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

ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.0 sites199 target enrollmentMarch 8, 2012

ConditionsRecurrent Epithelial Ovarian Cancer and Other Solid Tumors MedDRA version: 14.1Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem 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: Not Applicable
Intervention: Not specified
Conditions: Recurrent Epithelial Ovarian Cancer and Other Solid Tumors
Sponsor: ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
Enrollment: 199
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 8, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

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. \- 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. \- 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\). \- Age \= 18 years. \- ECOG PS 0 \-1 \- Predicted life expectancy \= 12 weeks. \- Patients may have had prior therapy, providing the following conditions are met: 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. 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 (PD during chemotherapy) or resistant (PD within six months of completing chemotherapy) to their last platinum\-containing chemotherapy regimen. Radiation: Patients may have had prior radiation therapy provided they have recovered from the acute, toxic effects of radiotherapy prior to registration/randomization. A minimum of 21 days must have elapsed between the end of radiotherapy and registration/randomization into the study unless the radiation affected less than 25% of bone marrow. Surgery: Previous surgery is permitted provided that adequate wound healing has occurred prior to registration/randomization. \- Fasting glucose \= 150 mg/dL (8\.3 mmol/L). \- Adequate hematopoietic, hepatic, and renal function defined as follows: Neutrophil count \= 1\.5 x 10 ^9 /L and platelet count \> \= 100 x 10^9/L; Bilirubin \= 1\.5 x ULN; AST and/or ALT \= 2\.5 x ULN or \< \= 5 x ULN if patient has documented liver metastases; and Serum creatinine \= 1\.5 x ULN. \- Patients – (For phase 1 both males and females, for phase 2 females and male partners) – with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must agree to practice effective contraceptive measures (ie, barrier methods that include condom or diaphragm, with spermicide) throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration/randomization. \- Patients must provide verbal and written informed consent to participate in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 139
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 60

Exclusion Criteria

•Patients who meet any of the following exclusion criteria are not eligible for enrollment. \- Diabetes mellitus currently requiring medication (eg, insulin or oral hypoglycemics). \- During the phase 2 portion, patients with histology of abdominal adenocarcinoma of unknown origin or a diagnosis of a borderline ovarian tumor. \- Previous or concurrent malignancies (excluding curatively treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) unless the patient has been in remission for at least 3 years. \- History of significant cardiovascular disease unless the disease is wellcontrolled. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease; 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). \- History of cerebrovascular accident (CVA) within 6 months prior to registration/randomization or that is not stable. \- Prior therapy with an IGF1R inhibitor. \- Known or prior hypersensitivity to taxanes or drugs containing Cremophor. \- Gastro\-intestinal abnormalities, including bowel obstruction, inability to take oral medication, requirement for intravenous (IV) alimentation,active peptic ulcer or prior surgical procedures or bowel resection affecting absorption. \- Active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to registration/randomization) that would impair the ability of the patient to receive protocol treatment. \- History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent. \- Pregnancy or breast\-feeding. \- Symptomatic brain metastases that are not stable, require steroids, are potentially life threatening, or that have required radiation within 28 days prior to registration/randomization. \- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug. \- 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. \- Use of drugs that have a known risk of causing Torsade de Pointes (TdP) or that that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing are prohibited. \- Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded.