A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)

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 elevated CA125 levels evaluable/assessable according to Gynecological Cancer Intergroup (GCIG) criteria (ie, \> 70 U/mL) documented by 2 measurements at least 1 week apart

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)

Eastern Cooperative Oncology Group (ECOG) performance status(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

1. Patient should have recovered from any drug-related toxicities (with the exception of grade 1 neuropathy and or alopecia)

2. 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

3. Phase 2: Patients must have received prior chemotherapy, which must have contained a platinum and a taxanes at some point. Any prior taxanes 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 computerized tomography (CT) scan progressive disease (PD) during chemotherapy) or resistant (radiologically confirmed by CT scan 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. Radiated lesions cannot be chosen as the target lesions

a. 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 Upper Limit of Normal (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

Female patient must be either:

* Of non childbearing potential:

1. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or

2. documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)

* Or, if of childbearing potential:

1. must have a negative urine pregnancy test at Screening, and

2. must use two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days \[or 5 half lives, whichever is longer\] after final study drug administration

Female patient must not be breastfeeding at Screening or during the study period and for 28 days \[or 5 half lives of the study drug whichever is longer\] after final study drug administration

Female patient must not donate ova starting at Screening and throughout the study period and for 28 days \[or 5 half lives of the study drug whichever is longer\] after final study drug administration

Patients must provide verbal and written informed consent to participate in the study

What this study is about