Breast Cancer Clinical Trial

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

Summary

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 patients with advanced or metastatic solid tumors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Part 2 (Dose Expansion)

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

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

117

Study ID:

NCT03717415

Recruitment Status:

Completed

Sponsor:

Deciphera Pharmaceuticals LLC

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There are 9 Locations for this study

See Locations Near You

University of California San Francisco (UCSF)
San Francisco California, 94115, United States
UCLA Medical Center
Santa Monica California, 90404, United States
University of Chicago
Chicago Illinois, 60637, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
The Ohio State University
Columbus Ohio, 43210, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
NEXT Oncology
San Antonio Texas, 78240, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

117

Study ID:

NCT03717415

Recruitment Status:

Completed

Sponsor:


Deciphera Pharmaceuticals LLC

How clear is this clinincal trial information?

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