Trial · NCT02097225

Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

NCT02097225, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2024-10-16

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery. Trials, record NCT02097225. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02097225

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
NCT number: NCT02097225
Status: Terminated
Phases: Phase 1
Enrollment: 22 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: BRAF V600E Mutation Present, BRAF V600K Mutation Present, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Unresectable Solid Neoplasm
Interventions: Dabrafenib, Laboratory Biomarker Analysis, Onalespib, Pharmacological Study, Trametinib
First posted: 2014-03-27
Last updated: 2024-10-16
Results first posted: 2024-10-16

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose of Dabrafenib	28 days after start of treatment	Maximum tolerated dose is defined as the highest dose level at which 0 or 1 of six patients has experienced a dose limiting toxicity (DLT) within 28 days after start of treatment. Toxicities will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. Participant enrollment occurred from July 2015 to June 2018, spanning Dose Levels 1-4. * Dose Level 1 (starting dose): * Dabrafenib = 150 mg * Trametinib = 1 mg * Onalespib = 180 mg/m2 * Dose Level 2: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 180 mg/m2 * Dose Level 3: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 220 mg/m2 * Dose Level 4: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 260 mg/m2
Primary	Maximum Tolerated Dose of Trametinib	28 days after start of treatment	Maximum tolerated dose is defined as the highest dose level at which 0 or 1 of six patients has experienced a dose limiting toxicity (DLT) within 28 days after start of treatment. Toxicities will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. Participant enrollment occurred from July 2015 to June 2018, spanning Dose Levels 1-4. * Dose Level 1 (starting dose): * Dabrafenib = 150 mg * Trametinib = 1 mg * Onalespib = 180 mg/m2 * Dose Level 2: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 180 mg/m2 * Dose Level 3: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 220 mg/m2 * Dose Level 4: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 260 mg/m2
Primary	Maximum Tolerated Dose of Onalespib	28 days after start of treatment	Maximum tolerated dose is defined as the highest dose level at which 0 or 1 of six patients has experienced a dose limiting toxicity (DLT) within 28 days after start of treatment. Toxicities will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. Participant enrollment occurred from July 2015 to June 2018, spanning Dose Levels 1-4. * Dose Level 1 (starting dose): * Dabrafenib = 150 mg * Trametinib = 1 mg * Onalespib = 180 mg/m2 * Dose Level 2: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 180 mg/m2 * Dose Level 3: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 220 mg/m2 * Dose Level 4: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 260 mg/m2
Primary	Number of Dose Limiting Toxicities While Determining Maximum Tolerated Dose	28 days after start of treatment (1 cycle)	Dose limiting toxicities (DLTs) are at least possibly related to study treatment and graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) v5.0: * any grade 4 toxicity * grade 3 (or grade 2 intolerable) non-hematologic toxicity (including fatigue lasting \>1 week or that requires hospitalization) * grade 3 or higher hematologic toxicity with complications (e.g., thrombocytopenia with bleeding, neutropenia with fever) * toxicity that lead to missing a dose of onalespib or \>25% of dabrafenib/trametinib in the first cycle The following grade 3 toxicities are not considered DLTs: * cutaneous squamous cell carcinoma or keratoacanthoma * nausea, vomiting, or diarrhea persisting \</= 72 hours with maximum supportive care * electrolyte events that resolve with replacement within 24 hours * any grade lymphopenia * lab abnormalities that return to baseline within 7 days: elevated bilirubin, AST, ALT, cholesterol, amylase, lipase, creatinine, hypertriglyceridemia
Secondary	Objective Response Rate	up to 9 months	Objective response rate is defined as the number of participants with complete response or partial response as their best response to therapy assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1. * Complete response (CR) = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response (PR) = At least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters.
Secondary	Progression-free Survival	up to 9 months	Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progressive disease assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, or death, whichever occurs first. Progressive disease (PD) = At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the baseline sum of diameters. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progressions.
Secondary	Progression-free Survival at 6 Months	6 months	Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progressive disease assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, or death, whichever occurs first. PFS at 6 months will report the number of participants without progression at 6 months after starting treatment. Progressive disease (PD) = At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the baseline sum of diameters. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progressions.
Secondary	Overall Survival at 1 Year	1 year	Overall survival (OS) is defined as the time from start of treatment to death from any cause. OS at 1 year will report the number of participants alive at 1 year after starting treatment.
Other	Pharmacokinetics of Dabrafenib, Trametinib, and Onalespib Combination	1 hour immediately after Cycle 1, Day 1 infusion	Pharmacokinetics (PKs) represents the absorption, distribution, metabolism, and elimination of study drugs from the body. PKs for this study are reported a Area Under the Curve (AUC), which is estimated using the trapezoidal rule based on the average drug concentrations in blood samples, specifically blood plasma, at 1 hour immediately after study drug infusion. AUC gives insight into the extent of exposure to a drug and its clearance rate from the body.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose of Dabrafenib	28 days after start of treatment		mg	NUMBER
PRIMARY	Maximum Tolerated Dose of Trametinib	28 days after start of treatment		mg	NUMBER
PRIMARY	Maximum Tolerated Dose of Onalespib	28 days after start of treatment		mg/m2	NUMBER
PRIMARY	Number of Dose Limiting Toxicities While Determining Maximum Tolerated Dose	28 days after start of treatment (1 cycle)		dose limiting toxicities	NUMBER
SECONDARY	Objective Response Rate	up to 9 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-free Survival	up to 9 months		months	MEDIAN
SECONDARY	Progression-free Survival at 6 Months	6 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival at 1 Year	1 year		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Pharmacokinetics of Dabrafenib, Trametinib, and Onalespib Combination	1 hour immediately after Cycle 1, Day 1 infusion	There were 18 out of 21 total evaluable patients had blood samples analyzed on Cycle 1 Day 1.	ng*hr/mL	MEDIAN

Source ClinicalTrials.gov

Results by group35

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Maximum Tolerated Dose of Dabrafenib	Treatment (Dabrafenib, Trametinib, Onalespib)		150	mg
Maximum Tolerated Dose of Trametinib	Treatment (Dabrafenib, Trametinib, Onalespib)		2	mg
Maximum Tolerated Dose of Onalespib	Treatment (Dabrafenib, Trametinib, Onalespib)		260	mg/m2
Number of Dose Limiting Toxicities While Determining Maximum Tolerated Dose	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	Grade 3 toxicity	0	dose limiting toxicities
Number of Dose Limiting Toxicities While Determining Maximum Tolerated Dose	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	Grade 3 toxicity	0	dose limiting toxicities
Number of Dose Limiting Toxicities While Determining Maximum Tolerated Dose	Dose Level 3: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 220 mg/m2	Grade 3 toxicity	5	dose limiting toxicities
Number of Dose Limiting Toxicities While Determining Maximum Tolerated Dose	Dose Level 4: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 260 mg/m2	Grade 3 toxicity	1	dose limiting toxicities
Number of Dose Limiting Toxicities While Determining Maximum Tolerated Dose	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	Grade 4 toxicity	0	dose limiting toxicities
Number of Dose Limiting Toxicities While Determining Maximum Tolerated Dose	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	Grade 4 toxicity	0	dose limiting toxicities
Number of Dose Limiting Toxicities While Determining Maximum Tolerated Dose	Dose Level 3: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 220 mg/m2	Grade 4 toxicity	0	dose limiting toxicities

1 to 10 of 35Source ClinicalTrials.gov

See all 35 results by group

Participant flow60

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Dose Level 1	STARTED	Dose Level -1: Dabrafenib = 75 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	0
Dose Level 1	STARTED	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	3
Dose Level 1	STARTED	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	0
Dose Level 1	STARTED	Dose Level 3: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 220 mg/m2	0
Dose Level 1	STARTED	Dose Level 4: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 260 mg/m2	0
Dose Level 1	COMPLETED	Dose Level -1: Dabrafenib = 75 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	0
Dose Level 1	COMPLETED	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	3
Dose Level 1	COMPLETED	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	0
Dose Level 1	COMPLETED	Dose Level 3: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 220 mg/m2	0
Dose Level 1	COMPLETED	Dose Level 4: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 260 mg/m2	0

1 to 10 of 60Source ClinicalTrials.gov

See all 60 participant flow

Adverse events152

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Thromboembolic Event	Vascular disorders	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	1	3
other	Thromboembolic Event	Vascular disorders	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	1	4
other	Thromboembolic Event	Vascular disorders	Dose Level 3: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 220 mg/m2	0	6
other	Thromboembolic Event	Vascular disorders	Dose Level 4: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 260 mg/m2	0	8
other	Abdominal Pain	Gastrointestinal disorders	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	0	3
other	Abdominal Pain	Gastrointestinal disorders	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	2	4
other	Abdominal Pain	Gastrointestinal disorders	Dose Level 3: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 220 mg/m2	0	6
other	Abdominal Pain	Gastrointestinal disorders	Dose Level 4: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 260 mg/m2	0	8
other	Constipation	Gastrointestinal disorders	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	0	3
other	Constipation	Gastrointestinal disorders	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	1	4

1 to 10 of 152Source ClinicalTrials.gov

See all 152 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	3	3
Total, all-cause mortality	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	4	4
Total, all-cause mortality	Dose Level 3: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 220 mg/m2	6	6
Total, all-cause mortality	Dose Level 4: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 260 mg/m2	7	8
Total, other adverse events	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	3	3
Total, other adverse events	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	4	4
Total, other adverse events	Dose Level 3: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 220 mg/m2	6	6
Total, other adverse events	Dose Level 4: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 260 mg/m2	8	8
Total, serious adverse events	Dose Level 1: Dabrafenib = 150 mg, Trametinib = 1 mg, Onalespib = 180 mg/m2	1	3
Total, serious adverse events	Dose Level 2: Dabrafenib = 150 mg, Trametinib = 2 mg, Onalespib = 180 mg/m2	1	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37042037	DERIVED

Source PubMed

Grants3

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
P30CA006516	Dana-Farber/Harvard Cancer Center	EBERT, BENJAMIN LEVINE	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	1985 to 2025	NIH RePORTER
UM1CA186709	Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site)	SHAPIRO, GEOFFREY I.; FLAHERTY, KEITH T; KUFE, DONALD W.	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	2014 to 2025	NIH RePORTER
U01CA062490	Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis	KUFE, DONALD W.	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	1994 to 2013	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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