A Phase 1/2 Study Evaluating Intermittent and Continuous OSI 906 and Weekly Paclitaxel in Patients with Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)

Astellas Pharma Global Development, Inc.0 sites210 target enrollmentJune 5, 2009

ConditionsRecurrent Epithelial Ovarian Cancer and Other Solid Tumors MedDRA version: 14.1 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsPaclitaxel 6 mg/ml concentrate for solution for infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent Epithelial Ovarian Cancer and Other Solid Tumors
Sponsor: Astellas Pharma Global Development, Inc.
Enrollment: 210
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 5, 2009

End Date

October 31, 2013

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Astellas Pharma Global Development, Inc.

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following inclusion criteria to be eligible for participation in this study.
•1\. Histologically or cytologically confirmed epithelial ovarian carcinoma. Patients with fallopian or peritoneal cancer will also be eligible. Patients with any solid tumor that may be treated with weekly paclitaxel will be eligible for the phase 1 portion.
•2\. For the phase 2 portion, patients must have radiologically\-confirmed progressive disease by RECIST v1\.1 criteria within 6 months prior to randomization (patients must have measurable disease according to RECIST v1\.1\).
•3\. Age \>/\=18 years.
•4\. ECOG PS 0 – 1 (Appendix 13 2\).
•5\. Predicted life expectancy \>/\= 12 weeks.
•6\. Patients may have had prior therapy, providing the following conditions are met:
•a. Chemotherapy: Prior chemotherapy must have been completed at least 3 weeks prior to study enrollment (6 weeks for mitomycin C, nitrosoureas or high\-dose carboplatin \[\>/\= 600 mg/m²] and 4 weeks for investigational drugs) and the patient should have recovered from any drug\-related toxicities (with the exception of grade 1 neuropathy and or alopecia).
•Phase 1 – While there is no limit on the number of prior regimens for patients entered into the phase 1 portion, any prior taxane therapy must have been administered on a 3 week schedule.
•Phase 2 – Patients must have received prior chemotherapy, which must have contained a platinum and a taxane at some point. Any prior taxane therapy must have been administered on a 3 week schedule. A maximum of 2 prior chemotherapy regimens are permitted. Patients must be refractory (radiologically confirmed by CT scan PD during chemotherapy) or resistant (radilogically confirmed by CT scan PD within six months of completing chemotherapy) to their last platinum\-containing chemotherapy regimen.

Exclusion Criteria

•Patients are to be excluded for safety concerns, lack of suitability, or administrative reasons. Patients who meet any of the following exclusion criteria are not eligible for enrollment.
•1\. Diabetes mellitus currently requiring medication (eg, insulin or oral hypoglycemics).
•2\. During the phase 2 portion, patients with histology of abdominal adenocarcinoma of unknown origin or a diagnosis of a borderline ovarian tumor.
•3\. Previous or concurrent malignancies (excluding curatively treated basal or squamous cell carcinoma of the skin or cervical cacinoma in situ) unless the patient has been in remission for at least 3 years.
•4\. History of significant cardiovascular disease unless the disease is well\-controlled. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease; QTc interval \> 450 msec at baseline; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea).
•5\. History of arrhythmia (multifocal premature ventricular contractions \[PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (\= grade 3\), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded. Patients with mean QTcF interval \= 450 msec at screening are excluded.
•6\. Use of drugs that have a known risk of causing Torsade de Pointes (TdP) or that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing.
•7\. Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded.
•8\. History of cerebrovascular accident (CVA) within 6 months prior to registration/randomization or that is not stable.
•9\. Prior therapy with an IGF1R inhibitor.