A Phase 1b / 2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

Status: Active

Description

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.

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.
  • 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

Locations & Contacts

Colorado

Aurora
University of Colorado Hospital
Status: Approved
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Approved
Name Not Available

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Deciphera Pharmaceuticals LLC

Trial IDs

Primary ID DCC-2036-01-003
Secondary IDs NCI-2019-02623
Clinicaltrials.gov ID NCT03601897