Who is sponsoring NCT03370302?

NCT03370302 is sponsored by Calithera Biosciences, Inc.

What drugs are being tested in NCT03370302?

Interventions in NCT03370302: TAK-228.

What condition does NCT03370302 study?

NCT03370302 studies Advanced Nonhematological Neoplasms.

Is NCT03370302 still recruiting?

NCT03370302 is currently terminated. Last updated 8 February 2023.

Are results published for NCT03370302?

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

Last reviewed 2023-02-08 · How we verify

NCT03370302

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

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of TAK-228 as Single Agent in Adult East Asian Participants With Advanced Nonhematological Malignancies

Terminated Phase 1 Results posted Last updated 8 February 2023

What this trial tests

Phase 1 trial testing TAK-228 in Advanced Nonhematological Neoplasms in 28 participants. Terminated before completion.

Timeline

17 January 2018

Primary endpoint
28 August 2019

28 August 2019

Quick facts

Lead sponsor	Calithera Biosciences, Inc
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	28
Start date	17 January 2018
Primary completion	28 August 2019
Estimated completion	28 August 2019
Sites	4 locations across Taiwan, Japan, South Korea

Drugs / interventions tested

TAK-228 — full drug profile →

Conditions studied

Advanced Nonhematological Neoplasms — all drugs for Advanced Nonhematological Neoplasms →

Sponsor

Calithera Biosciences, Inc — full company profile →

Who can join

18 and older, any sex, with Advanced Nonhematological Neoplasms. 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.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Primary · Baseline up to 30 days after the last dose of study drug (up to Cycle 12 Day 58) (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	3
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	6
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	7
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	6
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	3
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	3

Number of Participants With Grade 3 or Higher TEAEs Primary · Baseline up to 30 days after the last dose of study drug (up to Cycle 12 Day 58) (Cycle length= 28 days)

Adverse event (AE) Grades were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	1
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	2
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	6
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	5
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	3
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	1

Number of Participants With Serious TEAEs Primary · Baseline up to 30 days after the last dose of study drug (up to Cycle 12 Day 58) (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	0
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	2
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	3
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	1
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	2
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	1

Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 1 Primary · Baseline up to Day 28 in Cycle 1 (Cycle length= 28 days)

Toxicity was evaluated according to NCI CTCAE version 4.03. DLT was defined as any of the following occurred events within the first 28 days of the administration of TAK-228 that were considered by investigator to be possibly related to therapy: Grade \>=3 nonhematologic toxicity except for inadequately treated Grade 3 nausea and/or vomiting and diarrhea, Grade 3 hyperglycemia lasting \<=14 days, Grade 3 rash lasting \<=3 days; Grade 3 thrombocytopenia with hemorrhage or requiring platelet transfusion; Grade 3 anemia requiring blood transfusion; Grade 4 neutropenia lasting \>7 days; Grade \>=3

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	0
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	0
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	3
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	0
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	0

Number of Participants With TEAEs Leading to Study Drug Discontinuation Primary · Baseline up to 30 days after the last dose of study drug (up to Cycle 12 Day 58) (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	1
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	0
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	2
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	0
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	0
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	1

Cmax: Maximum Observed Plasma Concentration for TAK-228 on Cycle 1 Day 1 Primary · Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	23.83	± 9.6
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	41.35	± 29.6
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	55.25	± 26.2
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	41.78	± 23.7
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	252.29	± 75.2
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	268.61	± 57.8

Cmax: Maximum Observed Plasma Concentration for TAK-228 on Cycle 1 Day 15 Primary · Cycle 1 Day 15 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	31.07	± 48.6
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	46.85	± 31.6
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	52.68	± 47.2
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	45.02	± 44.5
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	182.75	± 70.5
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	364.58	± 37.1

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-228 on Cycle 1 Day 1 Primary · Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	0.870	0.50 – 2.03
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	0.990	0.42 – 1.77
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	1.000	0.50 – 2.00
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	0.500	0.40 – 1.02
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	0.470	0.40 – 2.08
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	1.970	1.00 – 2.02

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-228 on Cycle 1 Day 15 Primary · Cycle 1 Day 15 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	1.000	0.50 – 2.08
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	0.965	0.52 – 1.98
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	1.500	0.92 – 3.00
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	1.000	0.85 – 2.08
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	2.630	1.97 – 4.10
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	2.000	0.50 – 2.00

Daily Dosing Arms, AUC24: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours for TAK-228 on Cycle 1 Day 1 Primary · Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	131.0311	± 43.269
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	192.2467	± 32.263
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	295.5497	± 41.724
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	177.9464	± 38.813

Daily Dosing Arms, AUC24: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours for TAK-228 on Cycle 1 Day 15 Primary · Cycle 1 Day 15 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Daily Dosing Arm: TAK-228 2 mg	221.0132	± 47.912
Dose Escalation, Daily Dosing Arm: TAK-228 3 mg	250.4458	± 29.806
Dose Escalation, Daily Dosing Arm: TAK-228 4 mg	341.1219	± 44.219
Dose Expansion, Daily Dosing Arm: TAK-228 3 mg	278.5369	± 74.527

Weekly Dosing Arms, AUC168: Area Under the Concentration-time Curve From 0 to 168 Hours for TAK-228 on Cycle 1 Day 1 Primary · Cycle 1 Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (Cycle length= 28 days)

Group	Value	95% CI
Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg	1636.7580	± 49.907
Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg	2010.5661	± 53.631

Adverse events — posted to ClinicalTrials.gov

Time frame: TEAEs are AEs that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Cycle 12 Day 58). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose Escalation, Daily Dosing Arm: TAK-228 2 mg

Serious: 0/3 (0%)

Deaths: 0/3

Dose Escalation, Daily Dosing Arm: TAK-228 3 mg

Serious: 2/6 (33%)

Deaths: 0/6

Dose Escalation, Daily Dosing Arm: TAK-228 4 mg

Serious: 3/7 (43%)

Deaths: 0/7

Dose Expansion, Daily Dosing Arm: TAK-228 3 mg

Serious: 1/6 (17%)

Deaths: 0/6

Dose Escalation, Weekly Dosing Arm: TAK-228 20 mg

Serious: 2/3 (67%)

Deaths: 0/3

Dose Escalation, Weekly Dosing Arm: TAK-228 30 mg

Serious: 1/3 (33%)

Deaths: 0/3

Serious adverse events (10 terms)

Reaction	System	Dose Escalation, Daily Dos…	Dose Escalation, Daily Dos…	Dose Escalation, Daily Dos…	Dose Expansion, Daily Dosi…	Dose Escalation, Weekly Do…	Dose Escalation, Weekly Do…
Genital Herpes	Infections and infestations	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Jaundice cholestatic	Hepatobiliary disorders	—	—	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—	—
Renal impairment	Renal and urinary disorders	—	—	—	—	—	—
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Enteritis	Gastrointestinal disorders	—	—	—	—	—	—
Cholangitis acute	Hepatobiliary disorders	—	—	—	—	—	—

Other adverse events (90 terms — click to expand)

Reaction	System	Dose Escalation, Daily Dos…	Dose Escalation, Daily Dos…	Dose Escalation, Daily Dos…	Dose Expansion, Daily Dosi…	Dose Escalation, Weekly Do…	Dose Escalation, Weekly Do…
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Gastrointestinal inflammation	Gastrointestinal disorders	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Rash erythmatous	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—
Gamma-glutamyltransferase increases	Investigations	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—
Gingival pain	Gastrointestinal disorders	—	—	—	—	—	—
Haematochezia	Gastrointestinal disorders	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Erythema multiforme	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Blood cholesterol increased	Investigations	—	—	—	—	—	—
Blood creatinine phosphokinase increased	Investigations	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—
Weight increased	Investigations	—	—	—	—	—	—

Most-reported serious reactions: Genital Herpes, Sepsis, Acute myocardial infarction, Jaundice cholestatic, Cerebrovascular accident, Renal impairment, Malignant neoplasm progression, Metastases to central nervous system.

Data from ClinicalTrials.gov NCT03370302 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability, recommended phase 2 dose (RP2D), and to characterize PK of TAK-228 administered once daily or once weekly to East Asian participants with advanced nonhematological malignancies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies.
Shimizu T, Kuboki Y, Lin CC, Yonemori K, et al · · 2022 · cited 7× · PMID 34843044 · DOI 10.1007/s11523-021-00855-w

Verify or expand the search:

Other trials of TAK-228

Trials testing the same drug.

NCT03097328 — Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma · Phase 2 · completed
NCT03154294 — Evaluation of the Safety and Tolerability of TAK-228 With TAK-117 and Paclitaxel in Advanced Solid Tumors · Phase 1 · completed
NCT02988986 — TAK-228 Plus Tamoxifen in Patients With ER-Positive, HER2-negative Breast Cancer · Phase 2 · completed
NCT02619669 — Neoadjuvant Run-In Study With TAK-228 Followed by Letrozole/TAK-228 in Women With High-Risk ER+/HER2- Breast Cancer · Phase 1 · withdrawn
NCT02987959 — Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas · Phase 2 · terminated

Other Calithera Biosciences, Inc trials

Trials by the same sponsor.

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NCT04540965 — Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects · Phase 1 · completed
NCT04265534 — KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamo · Phase 2 · terminated

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 NCT03370302 (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 Calithera Biosciences, Inc
Last refreshed: 8 February 2023

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/NCT03370302.

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

NCT03370302

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 (10 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of TAK-228

Other Calithera Biosciences, Inc trials

Verify against primary sources