Who is sponsoring NCT02079740?

NCT02079740 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT02079740?

Interventions in NCT02079740: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Navitoclax, Positron Emission Tomography, Trametinib.

What condition does NCT02079740 study?

NCT02079740 studies Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm.

Is NCT02079740 still recruiting?

NCT02079740 is currently active, enrolled. Last updated 30 September 2025.

Are results published for NCT02079740?

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

Last reviewed 2025-09-30 · How we verify

NCT02079740

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

Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors

Active, enrolled Phase 1, PHASE2 Results posted Last updated 30 September 2025

What this trial tests

Phase 1, PHASE2 trial testing Biopsy Procedure in Metastatic Malignant Solid Neoplasm in 96 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 March 2014

Primary endpoint
1 December 2022

6 March 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	26 March 2014
Primary completion	1 December 2022
Estimated completion	6 March 2026
Sites	2 locations across United States

Drugs / interventions tested

Biopsy Procedure
Biospecimen Collection — full drug profile →
Computed Tomography
Magnetic Resonance Imaging
Navitoclax — full drug profile →
Positron Emission Tomography
Trametinib (trametinib) — full drug profile →

Conditions studied

Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →
Refractory Malignant Solid Neoplasm — all drugs for Refractory Malignant Solid Neoplasm →
Unresectable Malignant Solid Neoplasm — all drugs for Unresectable Malignant Solid Neoplasm →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Metastatic Malignant Solid Neoplasm or Refractory Malignant Solid Neoplasm. 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.

(Phase 1b) Maximal Tolerated Dose of Trametinib and Navitoclax Primary · Within the first 42 days of treatment

Dose escalation uses a 3+3 enrollment design per dose level. The occurrence of 1 dose limiting toxicity (DLT) will prompt expansion of a given dose level to 6 participants. The occurrence of 2 DLTs in a given dose level will indicate that the maximal tolerated dose (MTD) has been exceeded, and expansion of the prior dose level to 6 participants will occur, if not already performed. The recommended phase 2 dose (RP2D) will be the highest dose level at which no more than 1 out of 6 participants experiences a DLT. Dose escalation will proceed until the MTD/RP2D have been determined.

Trametinib on Days 1-14

Group	Value	95% CI
Treatment (Trametinib, Navitoclax)	2

Navitoclax on Days 1-28

Group	Value	95% CI
Treatment (Trametinib, Navitoclax)	250

(Phase 1b) Dose-Limiting Toxicities of Trametinib and Navitoclox Primary · Within the first 42 days of treatment

Dose-limiting toxicity (DLT) are adverse events (AEs) that are serious enough to prevent an increase in dose level of that treatment. Grading based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. CTCAE version 5.0 will be utilized beginning April 1, 2018.

Grade 3 AST/ALT increased

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 1B = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 3B = Trametinib 1.5 mg + Navitoclax 200 mg	1
Cohort 3C = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 4C = Trametinib 2 mg + Navitoclax 200 mg	0
Cohort 5C = Trametinib 2 mg + Navitoclax 250 mg	0
Cohort 6C = Trametinib 2 mg + Navitoclax 300 mg	0

Grade 4 hypokalemia

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 1B = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 3B = Trametinib 1.5 mg + Navitoclax 200 mg	1
Cohort 3C = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 4C = Trametinib 2 mg + Navitoclax 200 mg	0
Cohort 5C = Trametinib 2 mg + Navitoclax 250 mg	0
Cohort 6C = Trametinib 2 mg + Navitoclax 300 mg	0

Grade 3 Bilirubin increase

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 1B = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 3B = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 3C = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 4C = Trametinib 2 mg + Navitoclax 200 mg	0
Cohort 5C = Trametinib 2 mg + Navitoclax 250 mg	0
Cohort 6C = Trametinib 2 mg + Navitoclax 300 mg	1

Grade 3 Enterocolitis

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 1B = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 3B = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 3C = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 4C = Trametinib 2 mg + Navitoclax 200 mg	0
Cohort 5C = Trametinib 2 mg + Navitoclax 250 mg	0
Cohort 6C = Trametinib 2 mg + Navitoclax 300 mg	1

(Phase 2) Response Rate Primary · Up to 6 months

Response rate is defined as the number of participants who achieve complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1: * CR = Disappearance of target lesion(s). Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm * PR = At least a 30% decrease in the sum of the longest diameter(s) of target lesion(s) Participants are considered evaluable for response if they had measurable disease present at baseline, received at least one cycle of therapy, and had their

Complete Response

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	0
Expansion Cohort 2 = GYN Cancer	0
Expansion Cohort 3 = Lung Cancer	0
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	0

Partial Response

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	0
Expansion Cohort 2 = GYN Cancer	6
Expansion Cohort 3 = Lung Cancer	0
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	1

(Phase 2) Progression-free Survival Primary · Up to 31 months

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progressive disease (PD) or death, whichever occurs first. PD is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 as at least a 20% increase in the (sum of the) longest diameter(s) of target lesion(s), and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	1.37	0.60 – 2.87
Expansion Cohort 2 = GYN Cancer	5.87	0.37 – 31.60
Expansion Cohort 3 = Lung Cancer	6.57	1.33 – 26.77
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	5.17	0.03 – 30.97

(Phase 2) Treatment Emergent Adverse Events Primary · up to 29 months on treatment

Treatment emergent adverse events (TEAEs) are undesirable events not present prior to study treatment, or an already present event that worsens either in intensity or frequency while on treatment. TEAEs are assessed as grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0. CTCAE criteria version 5.0 will be utilized beginning April 1, 2018. TEAEs are also assessed as possibly, probably, or definitely related to study treatment.

Grade 3 abdominal pain

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	1
Expansion Cohort 2 = GYN Cancer	0
Expansion Cohort 3 = Lung Cancer	0
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	0

Grade 3 ALT increase

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	0
Expansion Cohort 2 = GYN Cancer	3
Expansion Cohort 3 = Lung Cancer	1
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	0

Grade 3 anemia

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	1
Expansion Cohort 2 = GYN Cancer	1
Expansion Cohort 3 = Lung Cancer	0
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	1

Grade 3 AST increase

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	0
Expansion Cohort 2 = GYN Cancer	2
Expansion Cohort 3 = Lung Cancer	0
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	0

Grade 3 blood bilirubin increased

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	0
Expansion Cohort 2 = GYN Cancer	1
Expansion Cohort 3 = Lung Cancer	0
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	0

Grade 3 dehydration

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	0
Expansion Cohort 2 = GYN Cancer	1
Expansion Cohort 3 = Lung Cancer	0
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	0

Grade 3 diarrhea

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	0
Expansion Cohort 2 = GYN Cancer	1
Expansion Cohort 3 = Lung Cancer	0
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	0

Grade 3 hypertension

Group	Value	95% CI
Expansion Cohort 1 = Pancreatic Cancer	0
Expansion Cohort 2 = GYN Cancer	0
Expansion Cohort 3 = Lung Cancer	0
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	1

(Phase 1b) Pharmacokinetic Parameter Cmax for Trametinib and Navitoclax When Administered in Combination Secondary · Cycle 1 day 7 and day 21

Pharmacokinetic blood draw samples collected for the following parameter and reported as mean values per day: maximum observed plasma drug concentration (Cmax). Schedule A: * C1 D7 = pre-nav (0h) then 2h, 4h, 6h, 8h * C1 D8 = pre-tram (-1h = 23h post-nav) * C1 D21 = pre-tram (-1h); pre-nav (0h); then 2h, 4h, 6h, 8h post-nav * C1 D22 = pre-tram (-1h = 23h post-nav) * D1 of Cycle 2,4,8,12 (single trough) = pre-tram (-1h) Schedule B: * C1 D7, D14 = pre-tram (-1h); pre-nav (0h); then 2h, 4h, 6h, 8h post-nav * C1 D8, D15 = pre-tram (-1h = 23h post-nav) * D1 of Cycle 2,4,8,12 (single trough) = p

Day 7 Navitoclax Cmax

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	3120.0	1710.0 – 4190.0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	2374.0	562.0 – 4480.0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	3040.0	2890.0 – 3190.0

Day 21 Navitoclax Cmax

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	2325.0	374.0 – 4740.0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	1349.0	347.0 – 1860.0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	1405.0	1380.0 – 1430.0

Day 21 Trametinib Cmax

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	12.2	8.37 – 20.5
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	19.6	14.2 – 29.8
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	23.2	21.5 – 25.0

(Phase 1b) Pharmacokinetic Parameter AUC for Trametinib and Navitoclax When Administered in Combination Secondary · Cycle 1 day 7 and day 21

Pharmacokinetic blood draw samples collected for the following parameter and reported as mean values per day: area under the concentration time curve from zero (pre-dose) to 24 hours (AUC 0-24). Schedule A: * C1 D7 = pre-nav (0h) then 2h, 4h, 6h, 8h * C1 D8 = pre-tram (-1h = 23h post-nav) * C1 D21 = pre-tram (-1h); pre-nav (0h); then 2h, 4h, 6h, 8h post-nav * C1 D22 = pre-tram (-1h = 23h post-nav) * D1 of Cycle 2,4,8,12 (single trough) = pre-tram (-1h) Schedule B: * C1 D7, D14 = pre-tram (-1h); pre-nav (0h); then 2h, 4h, 6h, 8h post-nav * C1 D8, D15 = pre-tram (-1h = 23h post-nav) * D1 of

Day 7 Navitoclax AUC

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	52219.0	26752.0 – 66795.0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	35451.0	9148.5 – 67610.0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	48714.0	48038.5 – 49390

Day 21 Navitoclax AUC

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	30575.0	7385.0 – 44056.0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	24224.0	6177.0 – 38322.0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	25804.0	24609.0 – 26999.0

Day 21 Trametinib AUC

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	206.0	160.0 – 308.0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	311.0	221.0 – 483.0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	305.0	283.0 – 329.0

(Phase 1b) Pharmacokinetic Parameter C0 for Trametinib and Navitoclax When Administered in Combination Secondary · Cycle 1 day 7 and day 21

Pharmacokinetic blood draw samples collected for the following parameter and reported as mean values per day: trough plasma drug concentration (C0). Schedule A: * C1 D7 = pre-nav (0h) then 2h, 4h, 6h, 8h * C1 D8 = pre-tram (-1h = 23h post-nav) * C1 D21 = pre-tram (-1h); pre-nav (0h); then 2h, 4h, 6h, 8h post-nav * C1 D22 = pre-tram (-1h = 23h post-nav) * D1 of Cycle 2,4,8,12 (single trough) = pre-tram (-1h) Schedule B: * C1 D7, D14 = pre-tram (-1h); pre-nav (0h); then 2h, 4h, 6h, 8h post-nav * C1 D8, D15 = pre-tram (-1h = 23h post-nav) * D1 of Cycle 2,4,8,12 (single trough) = pre-tram (-1h

Day 7 Navitoclax C0

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	1156.7	510 – 1520
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	1012.0	314 – 1710
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	910.5	551 – 1270

Day 21 Navitoclax C0

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	1110	221 – 1860
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	584	207 – 1080
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	949	857 – 1040

Day 21 Trametinib C0

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	6.4	4.8 – 9.43
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	9.7	7.5 – 14.9
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	9.9	8.8 – 11.1

(Phase 1b) Response Rate Secondary · Up to 4 months

Complete Response

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 1B = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 3B = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 3C = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 4C = Trametinib 2 mg + Navitoclax 200 mg	0
Cohort 5C = Trametinib 2 mg + Navitoclax 250 mg	0
Cohort 6C = Trametinib 2 mg + Navitoclax 300 mg	0

Partial Response

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	0
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 1B = Trametinib 1 mg + Navitoclax 150 mg	0
Cohort 3B = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 3C = Trametinib 1.5 mg + Navitoclax 200 mg	0
Cohort 4C = Trametinib 2 mg + Navitoclax 200 mg	0
Cohort 5C = Trametinib 2 mg + Navitoclax 250 mg	1
Cohort 6C = Trametinib 2 mg + Navitoclax 300 mg	0

(Phase 1b and 2) Percent Change in Levels of Proteins/Messenger Ribonucleic Acids Implicated in Mitogen-activated Protein Kinase Signaling Secondary · up to 50 days

Paired pre-treatment and on treatment tumor biopsies will be obtained to assess the pharmacodynamic response to therapy (e.g., change in levels of proteins/mRNAs implicated in MAPK signaling). Results will be reported as a mean percent (%) change in MAPK transcripts day 15 vs day 0. Pre-treatment tumor tissue for analysis will be obtained either from archival tissue remaining from a participant's prior surgery, diagnostic biopsy, or other procedure performed during routine clinical care. Alternatively, study-related pre-treatment biopsies will be obtained between days -21 and -1 of treatment

Group	Value	95% CI
Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg	15.2	± 0
Cohort 1B = Trametinib 1 mg + Navitoclax 150 mg	-98.3	± 0
Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg	-39.5	± 25
Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg	-98.3	± 0
Cohort 3B = Trametinib 1.5 mg + Navitoclax 200 mg	6.0	± 67
Cohort 3C = Trametinib 1.5 mg + Navitoclax 200 mg	8.7	± 19
Cohort 5C = Trametinib 2 mg + Navitoclax 250 mg	-49.0	± 50
Cohort 6C = Trametinib 2 mg + Navitoclax 300 mg	-42.5	± 0
Expansion Cohort 2 = GYN Cancer	6.8	± 99
Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types	132.0	± 0
Expansion Cohort 1 = Pancreatic Cancer	175.3	± 229

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 34 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1A = Trametinib 1 mg + Navitoclax 150 mg

Serious: 0/3 (0%)

Deaths: 3/3

Cohort 2A = Trametinib 1.5 mg + Navitoclax 150 mg

Serious: 0/3 (0%)

Deaths: 3/3

Cohort 3A = Trametinib 1.5 mg + Navitoclax 200 mg

Serious: 1/3 (33%)

Deaths: 2/3

Cohort 1B = Trametinib 1 mg + Navitoclax 150 mg

Serious: 1/3 (33%)

Deaths: 3/3

Cohort 3B = Trametinib 1.5 mg + Navitoclax 200 mg

Serious: 1/8 (13%)

Deaths: 7/8

Cohort 3C = Trametinib 1.5 mg + Navitoclax 200 mg

Serious: 0/3 (0%)

Deaths: 3/3

Cohort 4C = Trametinib 2 mg + Navitoclax 200 mg

Serious: 1/3 (33%)

Deaths: 3/3

Cohort 5C = Trametinib 2 mg + Navitoclax 250 mg

Serious: 0/8 (0%)

Deaths: 6/8

Cohort 6C = Trametinib 2 mg + Navitoclax 300 mg

Serious: 1/4 (25%)

Deaths: 3/4

Expansion Cohort 1 = Pancreatic Cancer

Serious: 1/12 (8%)

Deaths: 10/12

Expansion Cohort 2 = GYN Cancer

Serious: 2/25 (8%)

Deaths: 14/25

Expansion Cohort 3 = Lung Cancer

Serious: 0/6 (0%)

Deaths: 4/6

Expansion Cohort 4 = All Other NRAS Mutation-positive Solid Tumor Types

Serious: 0/10 (0%)

Deaths: 6/10

Serious adverse events (14 terms)

Reaction	System	Cohort 1A = Trametinib 1 m…	Cohort 2A = Trametinib 1.5…	Cohort 3A = Trametinib 1.5…	Cohort 1B = Trametinib 1 m…	Cohort 3B = Trametinib 1.5…	Cohort 3C = Trametinib 1.5…	Cohort 4C = Trametinib 2 m…	Cohort 5C = Trametinib 2 m…	Cohort 6C = Trametinib 2 m…	Expansion Cohort 1 = Pancr…	Expansion Cohort 2 = GYN C…	Expansion Cohort 3 = Lung …	Expansion Cohort 4 = All O…
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Creatinine increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Enterocolitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (84 terms — click to expand)

Reaction	System	Cohort 1A = Trametinib 1 m…	Cohort 2A = Trametinib 1.5…	Cohort 3A = Trametinib 1.5…	Cohort 1B = Trametinib 1 m…	Cohort 3B = Trametinib 1.5…	Cohort 3C = Trametinib 1.5…	Cohort 4C = Trametinib 2 m…	Cohort 5C = Trametinib 2 m…	Cohort 6C = Trametinib 2 m…	Expansion Cohort 1 = Pancr…	Expansion Cohort 2 = GYN C…	Expansion Cohort 3 = Lung …	Expansion Cohort 4 = All O…
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash acneiform	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
White blood cell decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Bloating	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Edema limbs	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Blurred vision	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Mucositis oral	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Paronychia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Bruising	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—
Bullous dermatitis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Creatinine increased, Dehydration, Enterocolitis, Fatigue, Hyperglycemia, Hypocalcemia, Hypokalemia.

Data from ClinicalTrials.gov NCT02079740 adverse events section.

Sponsor's own description

This phase Ib/II trial studies the side effects and best dose of trametinib and navitoclax and how well they work in treating patients with solid tumors that have spread to other places in the body (advanced or metastatic). Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Navitoclax inhibits members of the BCL2 family of proteins that are believed to play key roles in promoting the survival of cancer cells. It may stop the growth of cancer cells by blocking Bcl-2, Bcl-XL, and Bcl-w, proteins needed for cancer cell survival. Giving trametinib and navitoclax may help stop the growth of tumor cells.

Publications & conference data

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

Targeting apoptosis in cancer therapy.
Carneiro BA, El-Deiry WS. · · 2020 · cited 1823× · PMID 32203277 · DOI 10.1038/s41571-020-0341-y
Cellular senescence in ageing: from mechanisms to therapeutic opportunities.
Di Micco R, Krizhanovsky V, Baker D, d'Adda di Fagagna F. · · 2021 · cited 1687× · PMID 33328614 · DOI 10.1038/s41580-020-00314-w
Senescent cells: an emerging target for diseases of ageing.
Childs BG, Gluscevic M, Baker DJ, Laberge RM, et al · · 2017 · cited 994× · PMID 28729727 · DOI 10.1038/nrd.2017.116
The BCL2 Family: Key Mediators of the Apoptotic Response to Targeted Anticancer Therapeutics.
Hata AN, Engelman JA, Faber AC. · · 2015 · cited 472× · PMID 25895919 · DOI 10.1158/2159-8290.cd-15-0011
Cellular senescence: a key therapeutic target in aging and diseases.
Zhang L, Pitcher LE, Yousefzadeh MJ, Niedernhofer LJ, et al · · 2022 · cited 429× · PMID 35912854 · DOI 10.1172/jci158450
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
A combinatorial strategy for treating KRAS-mutant lung cancer.
Manchado E, Weissmueller S, Morris JP, Chen CC, et al · · 2016 · cited 342× · PMID 27338794 · DOI 10.1038/nature18600
Cancer-Associated Fibroblasts Build and Secure the Tumor Microenvironment.
Liu T, Zhou L, Li D, Andl T, et al · · 2019 · cited 337× · PMID 31106200 · DOI 10.3389/fcell.2019.00060

Verify or expand the search:

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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 NCT02079740 (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 National Cancer Institute (NCI)
Last refreshed: 30 September 2025

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/NCT02079740.

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NCT02079740

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 (14 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Biopsy Procedure

Other recruiting trials for Metastatic Malignant Solid Neoplasm

Other National Cancer Institute (NCI) trials

Verify against primary sources