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Protein Kinase Inhibitor

Onalespib + Dabrafenib + Trametinib for Skin Cancer

Phase 1

Waitlist Available

Led By Ryan J Sullivan

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to swallow and retain oral medication, and must not have any clinically significant gastrointestinal abnormalities

All prior anti-cancer treatment-related toxicities must be less than or equal to grade 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing onalespib, dabrafenib, and trametinib to see if they help treat BRAF-mutant melanoma or metastatic solid tumors. Onalespib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for adults with BRAF-mutant melanoma or solid tumors that have spread (metastatic) or can't be surgically removed. They should have manageable side effects from previous cancer treatments, good physical health, and a life expectancy over 3 months. Women must test negative for pregnancy and use birth control. Participants must not have had HSP90 inhibitors before, no uncontrolled illnesses, no recent anti-cancer therapies within 3 weeks, and no history of certain severe reactions or diseases.Check my eligibility

What is being tested?

The trial tests the combination of Onalespib with Dabrafenib and Trametinib to find the safest dose and see how it affects tumor growth in patients with advanced melanoma or solid tumors carrying a specific mutation (BRAF V600E/K). It's an early-phase study focusing on dosage safety rather than effectiveness.See study design

What are the potential side effects?

Potential side effects include issues related to blocking enzymes needed by tumor cells which may affect normal cell functions too. This could lead to problems like fatigue, digestive disturbances, skin reactions, liver enzyme changes, heart complications among others depending on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take pills and don't have major stomach or intestine problems.

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My side effects from previous cancer treatments are mild.

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I am fully active and can carry on all pre-disease activities without restriction.

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My cancer is BRAF V600E/K mutant, cannot be surgically removed, and has spread.

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I have previously been treated with full-dose BRAF or BRAF and MEK inhibitors, or I have never received BRAF-targeted therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose of onalespib in combination with dabrafenib and trametinib, defined as the highest dose level at which 0 or 1 of six patients has experienced a dose limiting toxicity

Secondary outcome measures

Disease-free survival

Objective response rate, defined as the proportion of patients with complete or partial response as their best response to therapy assessed according to Response Evaluation Criteria in Solid Tumors version 1.1

Overall survival

+1 more

Other outcome measures

Changes in the expression of the key signaling proteins

Pharmacokinetic parameters (maximal plasma or serum concentration, area under the curve to the last collection point, area under the curve for dose interval, and time of maximal concentration)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (dabrafenib, trametinib, onalespib)Experimental Treatment5 Interventions

Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28, and onalespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dabrafenib

2011

Completed Phase 3

~4120

Onalespib

2017

Completed Phase 1

~30

Trametinib

2014

Completed Phase 2

~1550

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,131 Total Patients Enrolled

557 Trials studying Melanoma

193,211 Patients Enrolled for Melanoma

Ryan J SullivanPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

75 Total Patients Enrolled

1 Trials studying Melanoma

75 Patients Enrolled for Melanoma

Media Library

Dabrafenib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02097225 — Phase 1

Melanoma Research Study Groups: Treatment (dabrafenib, trametinib, onalespib)

Melanoma Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT02097225 — Phase 1

Dabrafenib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02097225 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available to individuals seeking participation in this research?

"This trial is not currently accepting new patients, as its last update was on June 28th 2022. However, you may be interested in other medical studies; there are presently 3107 active recruitment trials related to BRAF V600K mutation and 98 studies involving Onalespib that need volunteers."

Answered by AI

Are there any extant investigations utilizing Onalespib?

"Currently, there are 98 clinical trials actively underway for Onalespib with 6 at the Phase 3 level. A majority of these studies are conducted in Honolulu, Hawaii yet a total of 5821 locations have registered to conduct research on this drug."

Answered by AI

How many participants are actively enrolled in this scientific experiment?

"This study is no longer recruiting participants, with the first posting on May 29th 2014 and last update occurring on June 28th 2022. For those exploring alternative trials, there are 3107 clinical studies actively seeking patients with a BRAF V600K mutation present and 98 Onalespib investigations currently in need of volunteers."

Answered by AI