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.
- Locally Advanced or Metastatic Solid Tumor
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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
- Phase 1/Phase 2
- Study Type
- Intervention Model
- Sequential Assignment
- Primary Purpose
- None (Open Label)
|Dose comparison between 50 or 100 mg BID of rebastinib orally (PO) in combination with paclitaxel administered by IV infusion at 80 mg/m2 in repeated 28-day cycles.||
|Dose expansion in the following tumor types at the recommended Phase 2 dose (RP2D) of rebastinib in combination with paclitaxel Triple-negative and Stage IV inflammatory breast cancer Ovarian cancer Endometrial cancer Gynecological Carcinosarcoma||
- Deciphera Pharmaceuticals LLC
Study ContactClinical Trials