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A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors

NCT ID: NCT03717415

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2022-11-01

Brief Summary

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This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic solid tumors.

Detailed Description

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Conditions

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Locally Advanced or Metastatic Solid Tumor

Keywords

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rebastinib breast cancer ovarian cancer mesothelioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5

Dose escalation with rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in 21-day cycles in combination with carboplatin administered by intravenous (IV) infusion at area under the curve (AUC)5 at Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

Rebastinib

Intervention Type DRUG

Administered orally

Carboplatin

Intervention Type DRUG

Administered by IV infusion

Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5

Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

Rebastinib

Intervention Type DRUG

Administered orally

Carboplatin

Intervention Type DRUG

Administered by IV infusion

Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6

Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

Rebastinib

Intervention Type DRUG

Administered orally

Carboplatin

Intervention Type DRUG

Administered by IV infusion

Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5

Dose expansion in triple-negative breast cancer (TNBC) participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

Rebastinib

Intervention Type DRUG

Administered orally

Carboplatin

Intervention Type DRUG

Administered by IV infusion

Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5

Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

Rebastinib

Intervention Type DRUG

Administered orally

Carboplatin

Intervention Type DRUG

Administered by IV infusion

Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5

Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

Rebastinib

Intervention Type DRUG

Administered orally

Carboplatin

Intervention Type DRUG

Administered by IV infusion

Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5

Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

Rebastinib

Intervention Type DRUG

Administered orally

Carboplatin

Intervention Type DRUG

Administered by IV infusion

Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5

Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

Rebastinib

Intervention Type DRUG

Administered orally

Carboplatin

Intervention Type DRUG

Administered by IV infusion

Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5

Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

Rebastinib

Intervention Type DRUG

Administered orally

Carboplatin

Intervention Type DRUG

Administered by IV infusion

Interventions

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Rebastinib

Administered orally

Intervention Type DRUG

Carboplatin

Administered by IV infusion

Intervention Type DRUG

Other Intervention Names

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DCC-2036

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients ≥18 years of age at the time of informed consent.
2. Part 1 (Dose Escalation). Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin is considered appropriate treatment.
3. Part 2 (Dose Expansion)

* Previously treated, triple-negative breast cancer.
* Recurrent platinum-sensitive ovarian cancer.
* Histologically confirmed pleural or peritoneal malignant mesothelioma.
4. ECOG performance status of ≤2.
5. Able to provide an archival tumor tissue sample.
6. Adequate organ function and bone marrow reserve.
7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment.
8. Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures.

Exclusion Criteria

1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life (whichever is shorter) prior to the first dose.
2. Not recovered from prior-treatment toxicities to Grade ≤1 or baseline.
3. Peripheral neuropathy of any etiology \>Grade 1.
4. Concurrent malignancy.
5. Known active CNS metastases.
6. Use of systemic corticosteroids.
7. Known retinal neovascularization, macular edema or macular degeneration.
8. History or presence of clinically relevant cardiovascular abnormalities.
9. QTcF \>450 ms in males or \>470 ms in females.
10. Left ventricular ejection fraction (LVEF) \<50% at screening.
11. Arterial thrombotic or embolic events.
12. Symptomatic venous thrombotic event.
13. Active infection ≥Grade 3.
14. Known HIV or HCV infection only if taking medications excluded per protocol, active HBV, or active HCV infection.
15. Use of proton pump inhibitors.
16. If female, the patient is pregnant or lactating.
17. Major surgery 4 weeks prior to the first dose of study drug.
18. Malabsorption syndrome or other illness which could affect oral absorption.
19. Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
20. Any other clinically significant comorbidities.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deciphera Pharmaceuticals, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California San Francisco (UCSF)

San Francisco, California, United States

Site Status

UCLA Medical Center

Santa Monica, California, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

NEXT Oncology

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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DCC-2036-01-004

Identifier Type: -

Identifier Source: org_study_id