Who is sponsoring NCT00830869?

NCT00830869 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT00830869?

Interventions in NCT00830869: IXAZOMIB.

What condition does NCT00830869 study?

NCT00830869 studies Advanced Non-hematologic Malignancies.

Is NCT00830869 still recruiting?

NCT00830869 is currently completed. Last updated 9 September 2019.

Are results published for NCT00830869?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-09-09 · How we verify

NCT00830869

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies

Completed Phase 1 Results posted Last updated 9 September 2019

What this trial tests

Phase 1 trial testing IXAZOMIB in Advanced Non-hematologic Malignancies in 116 participants. Completed in 20 April 2012.

Timeline

2 March 2009

Primary endpoint
20 April 2012

20 April 2012

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	116
Start date	2 March 2009
Primary completion	20 April 2012
Estimated completion	20 April 2012
Sites	7 locations across Canada, United States

Drugs / interventions tested

IXAZOMIB (IXAZOMIB) — full drug profile →

Conditions studied

Advanced Non-hematologic Malignancies — all drugs for Advanced Non-hematologic Malignancies →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Non-hematologic Malignancies. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Number of Participants With Dose Limiting Toxicity (DLT) Primary · Part 1: Cycle 1 Day 1 up to Cycle 1 Day 21

Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLT is any of following related to ixazomib:Grade (GR) 4 neutropenia (absolute neutrophil count\<500 cells/cubic meter\[cells/mm\^3\])for\>7 days; GR 3 neutropenia with coincident fever and/or infection; GR 4 thrombocytopenia (platelets \<25,000 cells/mm3)for\>7 days; GR 3 thrombocytopenia with clinically significant bleeding; Platelet count\<10,000 cells/mm3; GR 3 peripheral neuropathy;\>=GR 3 nausea/emesis in absence of optimal antiemetic therapy; \>=GR 3 diarrhoea in abse

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	1
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	1
Part 1: Ixazomib 2.34 mg/m^2	3

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs) Primary · Part 1: Cycle 1 Day 1 up to Cycle 10 Day 41; Part 2: Cycle 1 Day 1 up to Cycle 12 Day 41

TEAEs

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	1
Part 1: Ixazomib 0.25 mg/m^2	1
Part 1: Ixazomib 0.5 mg/m^2	1
Part 1: Ixazomib 1 mg/m^2	7
Part 1: Ixazomib 1.33 mg/m^2	4
Part 1: Ixazomib 1.76 mg/m^2	6
Part 1: Ixazomib 2.34 mg/m^2	3
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	20
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	22
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	19
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	11
Part 2: Ixazomib 1.76 mg/m^2-TPEC	20

SAEs

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	1
Part 1: Ixazomib 0.25 mg/m^2	1
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	1
Part 1: Ixazomib 1.33 mg/m^2	1
Part 1: Ixazomib 1.76 mg/m^2	4
Part 1: Ixazomib 2.34 mg/m^2	3
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	9
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	10
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	7
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	6
Part 2: Ixazomib 1.76 mg/m^2-TPEC	11

Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities Primary · Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)

Liver function analyses

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	2
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	1
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	1
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	1
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	1
Part 2: Ixazomib 1.76 mg/m^2-TPEC	1

Renal function analyses

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	0
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	2
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	0
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	4
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	0
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	0
Part 2: Ixazomib 1.76 mg/m^2-TPEC	1

Tissue enzyme analyses notelsewhereclassified(NEC)

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	2
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	0
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	0
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	0
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	2
Part 2: Ixazomib 1.76 mg/m^2-TPEC	2

Red blood cell analyses

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	1
Part 1: Ixazomib 1 mg/m^2	1
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	0
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	2
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	0
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	1
Part 2: Ixazomib 1.76 mg/m^2-TPEC	0

Platelet analyses

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	0
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	2
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	0
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	1
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	1
Part 2: Ixazomib 1.76 mg/m^2-TPEC	0

Mineral and electrolyte analyses

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	0
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	0
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	0
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	0
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	0
Part 2: Ixazomib 1.76 mg/m^2-TPEC	2

Metabolism tests NEC

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	0
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	0
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	0
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	0
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	1
Part 2: Ixazomib 1.76 mg/m^2-TPEC	0

Urinalysis NEC

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	0
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	0
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	0
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	0
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	0
Part 2: Ixazomib 1.76 mg/m^2-TPEC	1

Number of Participants With Clinically Significant Change From Baseline in Vital Signs Primary · Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)

Vital sign measurements included diastolic and systolic blood pressure, heart rate, weight and oral temperature.

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	0
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	0
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	0
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	0
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	0
Part 2: Ixazomib 1.76 mg/m^2-TPEC	0

Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib Secondary · Part 1: Cycle 1 Days 1 and 11: pre-dose and at multiple time points (up to 72 hours) post-dose

AUC (0-72) is a measure of the area under the plasma concentration-time curve from time 0 to 72 hours post-dose for ixazomib.

Cycle 1 Day 1

Group	Value	95% CI
Part 1: Ixazomib 0.5 mg/m^2	91.6	± NA
Part 1: Ixazomib 1 mg/m^2	191.87	± 40.211
Part 1: Ixazomib 1.33 mg/m^2	391.46	± 92.446
Part 1: Ixazomib 1.76 mg/m^2	522.74	± 120.122
Part 1: Ixazomib 2.34 mg/m^2	620.0	± NA

Cycle 1 Day 11

Group	Value	95% CI
Part 1: Ixazomib 0.25 mg/m^2	60.9	± NA
Part 1: Ixazomib 0.5 mg/m^2	301.00	± NA
Part 1: Ixazomib 1 mg/m^2	579.91	± 246.505
Part 1: Ixazomib 1.33 mg/m^2	1161.92	± 424.774
Part 1: Ixazomib 1.76 mg/m^2	1542.64	± 454.015
Part 1: Ixazomib 2.34 mg/m^2	3800.0	± NA

Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration Secondary · Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

C0 is the plasma drug concentration at time zero following bolus intravenous injection.

Cycle 1 Day 1

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	15.1	± NA
Part 1: Ixazomib 0.25 mg/m^2	82.5	± NA
Part 1: Ixazomib 0.5 mg/m^2	192.0	± NA
Part 1: Ixazomib 1 mg/m^2	346.70	± 170.208
Part 1: Ixazomib 1.33 mg/m^2	366.16	± 146.167
Part 1: Ixazomib 1.76 mg/m^2	579.54	± 210.672
Part 1: Ixazomib 2.34 mg/m^2	901.0	± NA

Cycle 1 Day 11

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	27.1	± NA
Part 1: Ixazomib 0.25 mg/m^2	69.0	± NA
Part 1: Ixazomib 0.5 mg/m^2	83.8	± NA
Part 1: Ixazomib 1 mg/m^2	272.57	± 64.044
Part 1: Ixazomib 1.33 mg/m^2	390.08	± 209.538
Part 1: Ixazomib 1.76 mg/m^2	648.97	± 597.508
Part 1: Ixazomib 2.34 mg/m^2	869.0	± NA

Part 1: Rac: Accumulation Ratio for Ixazomib Secondary · Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose

Rac was estimated as the ratio of AUC (0-72) on Day 11 and AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time 0 to 72 hours post-dose.

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	2.210	± NA
Part 1: Ixazomib 0.25 mg/m^2	5.160	± NA
Part 1: Ixazomib 0.5 mg/m^2	3.290	± NA
Part 1: Ixazomib 1 mg/m^2	2.996	± 1.5948
Part 1: Ixazomib 1.33 mg/m^2	2.831	± 0.7228
Part 1: Ixazomib 1.76 mg/m^2	3.086	± 0.4998
Part 1: Ixazomib 2.34 mg/m^2	6.130	± NA

Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib Secondary · Part 1: Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

T1/2 is the time required for half of the drug to be eliminated from the plasma.

Group	Value	95% CI
Part 1: Ixazomib 1 mg/m^2	171.90	± 38.070
Part 1: Ixazomib 1.33 mg/m^2	144.69	± 27.647
Part 1: Ixazomib 1.76 mg/m^2	104.84	± 39.646
Part 1: Ixazomib 2.34 mg/m^2	90.80	± NA

Part 1: E Max: Maximum Observed Effect for Ixazomib Secondary · Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

E max is the maximum inhibition of 20S proteasome activity in whole blood.

Cycle 1 Day 1

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	7.70	± NA
Part 1: Ixazomib 0.25 mg/m^2	17.90	± NA
Part 1: Ixazomib 0.5 mg/m^2	28.20	± NA
Part 1: Ixazomib 1 mg/m^2	35.22	± 8.592
Part 1: Ixazomib 1.33 mg/m^2	46.73	± 9.424
Part 1: Ixazomib 1.76 mg/m^2	62.20	± 9.862
Part 1: Ixazomib 2.34 mg/m^2	67.40	± NA

Cycle 1 Day 11

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	4.50	± NA
Part 1: Ixazomib 0.25 mg/m^2	10.00	± NA
Part 1: Ixazomib 0.5 mg/m^2	46.10	± NA
Part 1: Ixazomib 1 mg/m^2	39.33	± 8.868
Part 1: Ixazomib 1.33 mg/m^2	54.30	± 4.058
Part 1: Ixazomib 1.76 mg/m^2	61.90	± 9.042
Part 1: Ixazomib 2.34 mg/m^2	70.40	± NA

Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib Secondary · Part 1: Cycle 1 Days 1 and 11 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose

TEmax is the time to reach the Emax, equal to time (hours) to Emax.

Cycle 1 Day 1

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	1.000	1.00 – 1.00
Part 1: Ixazomib 0.25 mg/m^2	0.100	0.10 – 0.10
Part 1: Ixazomib 0.5 mg/m^2	0.250	0.25 – 0.25
Part 1: Ixazomib 1 mg/m^2	0.100	0.08 – 0.10
Part 1: Ixazomib 1.33 mg/m^2	0.250	0.10 – 0.25
Part 1: Ixazomib 1.76 mg/m^2	0.080	0.07 – 0.10
Part 1: Ixazomib 2.34 mg/m^2	0.080	0.08 – 0.08

Cycle 1 Day 11

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	24.000	24.00 – 24.00
Part 1: Ixazomib 0.25 mg/m^2	0.080	0.08 – 0.08
Part 1: Ixazomib 0.5 mg/m^2	0.100	0.10 – 0.10
Part 1: Ixazomib 1 mg/m^2	0.110	0.10 – 0.12
Part 1: Ixazomib 1.33 mg/m^2	0.080	0.08 – 0.10
Part 1: Ixazomib 1.76 mg/m^2	0.120	0.08 – 0.18
Part 1: Ixazomib 2.34 mg/m^2	0.100	0.10 – 0.10

Number of Participants With Best Overall Response Secondary · Day 18 up to Day 21 of each cycle (Part 1: up to Cycle 10; Part 2: up to Cycle 12)

Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the baseline sm

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	0
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	0
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	0
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	0
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	0
Part 2: Ixazomib 1.76 mg/m^2-TPEC	0

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	0
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	0
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	0
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	1
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	0
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	0
Part 2: Ixazomib 1.76 mg/m^2-TPEC	0

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	0
Part 1: Ixazomib 0.25 mg/m^2	1
Part 1: Ixazomib 0.5 mg/m^2	0
Part 1: Ixazomib 1 mg/m^2	1
Part 1: Ixazomib 1.33 mg/m^2	0
Part 1: Ixazomib 1.76 mg/m^2	2
Part 1: Ixazomib 2.34 mg/m^2	2
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	5
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	5
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	8
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	3
Part 2: Ixazomib 1.76 mg/m^2-TPEC	3

Progressive disease

Group	Value	95% CI
Part 1: Ixazomib 0.125 mg/m^2	1
Part 1: Ixazomib 0.25 mg/m^2	0
Part 1: Ixazomib 0.5 mg/m^2	1
Part 1: Ixazomib 1 mg/m^2	5
Part 1: Ixazomib 1.33 mg/m^2	3
Part 1: Ixazomib 1.76 mg/m^2	3
Part 1: Ixazomib 2.34 mg/m^2	0
Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)	10
Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)	8
Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)	8
Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)	7
Part 2: Ixazomib 1.76 mg/m^2-TPEC	14

Part 2: Ixazomib Concentration in Postdose Clinical Tumor Samples in Ixazomib 1.76 mg/m^2-TPEC Secondary · Cycle 1 Days 1 and 4: Predose and (from 4-20 hours) post-dose

The average data of Days 1 and 4 of Cycle 1 was reported.

Group	Value	95% CI
Part 2: Ixazomib 1.76 mg/m^2-TPEC	525	± 342

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Part 1: Cycle 10 Day 41, Part 2: Cycle 12 Day 41). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Ixazomib 0.125 mg/m^2

Serious: 1/1 (100%)

Deaths: 0/1

Part 1: Ixazomib 0.25 mg/m^2

Serious: 1/1 (100%)

Deaths: 0/1

Part 1: Ixazomib 0.5 mg/m^2

Serious: 0/1 (0%)

Deaths: 0/1

Part 1: Ixazomib 1 mg/m^2

Serious: 1/7 (14%)

Deaths: 1/7

Part 1: Ixazomib 1.33 mg/m^2

Serious: 1/4 (25%)

Deaths: 1/4

Part 1: Ixazomib 1.76 mg/m^2

Serious: 4/6 (67%)

Deaths: 0/6

Part 1: Ixazomib 2.34 mg/m^2

Serious: 3/3 (100%)

Deaths: 1/3

Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)

Serious: 9/20 (45%)

Deaths: 0/20

Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)

Serious: 10/22 (45%)

Deaths: 2/22

Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)

Serious: 7/20 (35%)

Deaths: 1/20

Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)

Serious: 6/11 (55%)

Deaths: 0/11

Part 2: Ixazomib 1.76 mg/m^2-TPEC

Serious: 11/20 (55%)

Deaths: 1/20

Serious adverse events (58 terms)

Reaction	System	Part 1: Ixazomib 0.125 mg/…	Part 1: Ixazomib 0.25 mg/m^2	Part 1: Ixazomib 0.5 mg/m^2	Part 1: Ixazomib 1 mg/m^2	Part 1: Ixazomib 1.33 mg/m^2	Part 1: Ixazomib 1.76 mg/m^2	Part 1: Ixazomib 2.34 mg/m^2	Part 2:Ixazomib 1.76 mg/m^…	Part 2: Ixazomib 1.76 mg/m…	Part 2: Ixazomib 1.76 mg/m…	Part 2: Ixazomib 1.76 mg/m…	Part 2: Ixazomib 1.76 mg/m…
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (209 terms — click to expand)

Reaction	System	Part 1: Ixazomib 0.125 mg/…	Part 1: Ixazomib 0.25 mg/m^2	Part 1: Ixazomib 0.5 mg/m^2	Part 1: Ixazomib 1 mg/m^2	Part 1: Ixazomib 1.33 mg/m^2	Part 1: Ixazomib 1.76 mg/m^2	Part 1: Ixazomib 2.34 mg/m^2	Part 2:Ixazomib 1.76 mg/m^…	Part 2: Ixazomib 1.76 mg/m…	Part 2: Ixazomib 1.76 mg/m…	Part 2: Ixazomib 1.76 mg/m…	Part 2: Ixazomib 1.76 mg/m…
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash pruritic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash erythematous	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oral candidiasis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Gingival bleeding	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Retching	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Swelling face	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Thrombocytopenia, Pneumonia, Dehydration, Dyspnoea, Pyrexia, Presyncope, Anaemia, Nausea.

Data from ClinicalTrials.gov NCT00830869 adverse events section.

Sponsor's own description

This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in participants with nonhematologic malignancies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Marizomib, a proteasome inhibitor for all seasons: preclinical profile and a framework for clinical trials.
Potts BC, Albitar MX, Anderson KC, Baritaki S, et al · · 2011 · cited 168× · PMID 21247382 · DOI 10.2174/156800911794519716
The proteasome as a druggable target with multiple therapeutic potentialities: Cutting and non-cutting edges.
Tundo GR, Sbardella D, Santoro AM, Coletta A, et al · · 2020 · cited 78× · PMID 32442437 · DOI 10.1016/j.pharmthera.2020.107579
The 26S proteasome is a multifaceted target for anti-cancer therapies.
Grigoreva TA, Tribulovich VG, Garabadzhiu AV, Melino G, et al · · 2015 · cited 55× · PMID 26295307 · DOI 10.18632/oncotarget.4619
Pharmacological Modulation of Ubiquitin-Proteasome Pathways in Oncogenic Signaling.
Sharma A, Khan H, Singh TG, Grewal AK, et al · · 2021 · cited 51× · PMID 34769401 · DOI 10.3390/ijms222111971
Switching from body surface area-based to fixed dosing for the investigational proteasome inhibitor ixazomib: a population pharmacokinetic analysis.
Gupta N, Zhao Y, Hui AM, Esseltine DL, et al · · 2015 · cited 45× · PMID 25377318 · DOI 10.1111/bcp.12542
Targeting Myc-driven stress addiction in colorectal cancer.
Saeed H, Leibowitz BJ, Zhang L, Yu J. · · 2023 · cited 35× · PMID 37119690 · DOI 10.1016/j.drup.2023.100963
Phase 1 study of ixazomib, an investigational proteasome inhibitor, in advanced non-hematologic malignancies.
Smith DC, Kalebic T, Infante JR, Siu LL, et al · · 2015 · cited 32× · PMID 25777468 · DOI 10.1007/s10637-015-0230-x
Population Pharmacokinetic Analysis of Ixazomib, an Oral Proteasome Inhibitor, Including Data from the Phase III TOURMALINE-MM1 Study to Inform Labelling.
Gupta N, Diderichsen PM, Hanley MJ, Berg D, et al · · 2017 · cited 31× · PMID 28290121 · DOI 10.1007/s40262-017-0526-4

Verify or expand the search:

Other trials of IXAZOMIB

Trials testing the same drug.

NCT01953783 — Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB · Phase 1 · completed
NCT01939899 — Phase 2 Study of Oral IXAZOMIB in Adult Participants With Relapsed and/or Refractory Follicular Lymphoma · Phase 2 · completed
NCT01659658 — Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Ligh · Phase 3 · terminated

Other Millennium Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob · Phase 1 · withdrawn
NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati · Phase 1 · completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab · Phase 1 · completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys · Phase 1 · completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00830869 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
Last refreshed: 9 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00830869.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00830869

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (58 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of IXAZOMIB

Other Millennium Pharmaceuticals, Inc. trials

Verify against primary sources