Breast Cancer Clinical Trial

A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel 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 paclitaxel 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 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel is considered appropriate treatment.

Part 2

Triple-negative and Stage IV inflammatory breast cancer.
Recurrent ovarian cancer.
Recurrent, metastatic or high-risk endometrial cancer.

Advanced (stage III or IV), or recurrent gynecological carcinosarcoma

Homologous or heterologous type carcinosarcoma (malignant mixed Mullerian tumor [MMMT] allowed
ECOG PS 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 prior to the first dose.
Not recovered from prior-treatment toxicities to Grade ≤1.
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.
Venous thrombotic event.
Active infection ≥Grade 3.
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:

177

Study ID:

NCT03601897

Recruitment Status:

Completed

Sponsor:

Deciphera Pharmaceuticals LLC

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There are 13 Locations for this study

See Locations Near You

University of Alabama Comprehensive Cancer Center
Birmingham Alabama, 35233, United States
University of Colorado Denver- Anschutz Medical Center
Aurora Colorado, 80045, United States
Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
The University of Kansas Clinical Research Center
Kansas City Kansas, 66160, United States
Dana-Farber
Boston Massachusetts, 02215, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Northwell Health/Monter Cancer Center
Lake Success New York, 11042, United States
Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Women & Infants Hospital
Providence Rhode Island, 02905, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Oncology Consultants- Texas Medical Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

177

Study ID:

NCT03601897

Recruitment Status:

Completed

Sponsor:


Deciphera Pharmaceuticals LLC

How clear is this clinincal trial information?

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