Active, not recruiting • Phasen I, II • Stufe IV • Medical Oncology • Post-Menopausal • Interventionell

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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

• 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.

Ausschlusskriterien

• 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