An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid Tumors
Trial 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 Requirements
Inclusion Criteria:
1. Male or female patients ≥18 years of age at the time of informed consent.
2. Part 1 Histologically confirmed diagnosis of a locally advanced or metastatic solid
tumor for which paclitaxel is considered appropriate treatment.
3. 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
4. ECOG PS of ≤2.
5. Able to provide an archival tumor tissue sample
6. Adequate organ function and bone marrow reserve
7. If a female of childbearing potential, must have a negative pregnancy test prior to
enrollment.
8. Patient must provide signed consent to participate in the study and is willing to
comply with study-specific procedures.
Exclusion Criteria:
1. Received prior anticancer or other investigational therapy within 28 days or 5× the
half-life prior to the first dose.
2. Not recovered from prior-treatment toxicities to Grade ≤1.
3. Peripheral neuropathy of any etiology >Grade 1.
4. Concurrent malignancy.
5. Known active CNS metastases.
6. Use of systemic corticosteroids.
7. Known retinal neovascularization, macular edema or macular degeneration.
8. History or presence of clinically relevant cardiovascular abnormalities.
9. QTcF >450 ms in males or >470 ms in females.
10. Left ventricular ejection fraction (LVEF) <50% at screening.
11. Arterial thrombotic or embolic events.
12. Venous thrombotic event.
13. Active infection ≥Grade 3.
14. HIV or HCV infection only if taking medications excluded per protocol, active HBV, or
active HCV infection.
15. Use of proton pump inhibitors.
16. If female, the patient is pregnant or lactating.
17. Major surgery 4 weeks prior to the first dose of study drug
18. Malabsorption syndrome or other illness which could affect oral absorption.
19. Known allergy or hypersensitivity to any component of rebastinib or any of its
excipients.
20. Any other clinically significant comorbidities