Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2027-05-31

Brief Summary

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Multicenter, open-label Phase 1b/2 study of ripretinib in combination with binimetinib in patients with gastrointestinal stromal tumor (GIST). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2).

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Detailed Description

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Conditions

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Gastrointestinal Stromal Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Escalation

Escalation Phase: Increasing doses of ripretinib in combination with increase doses of binimetinib in patients with advanced GIST who have progressed on at least imatinib or are intolerant to imatinib and are ripretinib naïve in repeated 28-day cycles.

Participants may remain on treatment until disease progression, unacceptable toxicity, or withdrawal of consent

Group Type EXPERIMENTAL

Ripretinib

Intervention Type DRUG

50 mg tablets

binimetinib

Intervention Type DRUG

15 mg tablets

Expansion

Ripretinib in combination with binimetinib at the recommended Phase 2 dose (RP2D) in patients with advanced GIST who have progressed on imatinib or are intolerant to imatinib and are naïve.

Participants may remain on treatment until disease progression, unacceptable toxicity, or withdrawal of consent

Group Type EXPERIMENTAL

Ripretinib

Intervention Type DRUG

50 mg tablets

binimetinib

Intervention Type DRUG

15 mg tablets

Interventions

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Ripretinib

50 mg tablets

Intervention Type DRUG

binimetinib

15 mg tablets

Intervention Type DRUG

Other Intervention Names

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DCC-2618, QINLOCK Mektovi

Eligibility Criteria

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Inclusion Criteria

1. Patients ≥18 years of age with advanced GIST (unresectable or metastatic).
2. Must have at least progressed on imatinib or have documented intolerance to imatinib.
3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
4. Patients must have a histologic diagnosis of GIST.
5. If a female of childbearing potential, must have a negative pregnancy test.
6. Adequate organ function and bone marrow function

Exclusion Criteria

1. Received prior anticancer therapy within 14 days or 5× the half-life whichever is longer) prior to the first dose.
2. Ongoing or prior participation in the DCC-2618-03-002 study.
3. Prior therapy with ripretinib.
4. Prior therapy with MEK inhibitor.
5. History of certain ocular disorders.
6. History of clinically significant hepatobiliary disease.
7. Known active central nervous system metastases.
8. History or presence of clinically relevant cardiovascular abnormalities.
9. Systemic arterial or venous thrombotic or embolic events within 6 months of first dose.
10. History of acute or chronic pancreatitis
11. History of chronic inflammatory bowel disease or Crohn's disease requiring intervention within 12 months of first dose.
12. Gastrointestinal abnormalities including but not limited to:

* inability to take oral medication,
* malabsorption syndromes

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No