NCT01485874

Doxorubicin + BIBF 1120 in Patients for Ovarian Cancer

A Phase I-II Clinical Trial of Pegylated Liposomal Doxorubicin (Doxil®) in Combination With BIBF 1120 in Patients With Ovarian Cancer: Hoosier Oncology Group GYN10-149

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine whether BIBF 1120 can be safely combined with pegylated liposomal doxorubicin (phase I), and to determine the clinical activity of the combination in patients with platinum-resistant ovarian cancer (phase II).

Detailed description

OUTLINE: This is a phase I/II multi-center study. Phase I: All patients will receive a fixed dose of pegylated liposomal doxorubicin (Doxil) of 40 mg/m2 administered IV every 28 days. The dose of BIBF 1120 will be escalated in successive cohorts of patients. A maximum of 12 cycles of combined therapy will be administered corresponding to maximum cumulative dose of PLD of 480 mg/m2. Continuation therapy with single agent BIBF 1120 may continue for selected patients. The escalation phase will follow the standard 3+3 design. Patients will be accrued to each dose level in cohorts of up to 3-6 evaluable patients. Escalation will continue until a DLT is observed, the highest dose level is reached, or medical judgment indicates. An expansion cohort of 3 to 6 patients will be treated at the MTD (or highest dose level if the MTD is not reached), in order to ensure tolerability of the regimen prior to initiating the Phase II component of the study. Phase II: Patients will receive a fixed dose of pegylated liposomal doxorubicin (Doxil) of 40 mg/m2 administered IV every 28 days. Patients will be treated at either dose Level +2 or the MTD dose level of BIBF 1120 as defined by the Phase I cohort. Each cycle will be 28 days. Patients will continue treatment with the combination therapy for a total of up to 12 cycles. ECOG Performance Status 0-1 Life Expectancy: Not specified Hematopoietic: * Absolute neutrophil count ≥ 1500 cells/mm3 * White cell blood count ≥ 3000 cells/mm3 * Hemoglobin ≥ 9.0 g/dL (can be post-transfusion) * Platelets ≥ 100,000/mm3 (can not be post-transfusion) Hepatic: * Aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times upper limit of normal (ULN) * Total serum bilirubin ≤ 1.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal: * Creatinine levels ≤ 1.5 times ULN Cardiovascular: * Baseline left ventricular ejection fraction greater than 50% * International Normalized ratio(INR) ≤ 1.5 times ULN, except patients on stable doses of coumadin or low molecular weight heparin NOTE: Patients on stable doses of coumadin or low molecular weight heparin are eligible if anticoagulant doses have been stable and no bleeding complications were recorded. * Partial thromboplastin time (PTT) ≤1.5 times ULN This study was terminated due to drug availability and Phase II never opened.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Doxil (Pegylated Liposomal Doxorubicin)	Phases I and II: 40 mg/m2 IV over 60 min (+/- 15 min) on day 1 of 28-day cycle
DRUG	BIBF 1120	Phase I: Escalating cohorts days -2 through +2, orally 100mg bid, 150mg bid, 200mg bid Phase II: MTD orally, bid, day 2 of 28-day cycle

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-12-06
• Last updated: 2022-02-15

Locations

2 sites across 1 country: United States