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

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.

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

Lead Organization
Deciphera Pharmaceuticals LLC

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