TERMINATED • Phasen I, II • Stufe IV • Post-Menopausal • Interventionell

Folgendes wird aus ClinicalTrials.gov importiert:

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

Brief 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.

Beschreibung

Studiendesign

Zulassungskriterien

Arms and Intervention

• Rebastinib

• Paclitaxel

Einschlusskriterien

• 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. eastern cooperative oncology group performance status (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

Ausschlusskriterien

• 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 central nervous system (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. qt interval corrected by fridericia's formula (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. human immunodeficiency virus (hiv) or hepatitis c (hcv) infection only if taking medications excluded per protocol, active hepatitis b (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