Linsitinib in Treating Patients With Asymptomatic or Mildly Symptomatic Metastatic Prostate Cancer

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the prostate
• Surgically or medically castrated, with testosterone levels of 470 msec (mean QTc with Bazett's correction) or history of familial long QT syndrome
• No other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-906
• No uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements
• Patients with insulin-dependent diabetes are excluded
• Patients with known history of HIV on combination antiretroviral therapy are ineligible
• Patients with known infectious hepatitis A, B, or C are ineligible
• No condition that, in the opinion of the investigator, would preclude participation in this trial
• See Disease Characteristics
• Prior therapy with ketoconazole and steroids is allowed provided patients have been off treatment for 4 weeks
• Prior investigational agents with novel adrenal inhibitors (i.e., Abiraterone or TAK700) are allowed provided these agents have been discontinued at least 4 weeks prior to enrollment
• Prior investigational agents with novel antiandrogens (i.e., MDV 3100) are allowed provided these agents have been discontinued at least 6 weeks prior to enrollment
• Prior therapy with Sipuleucel-T is allowed provided patients have documented evidence of disease progression as stated above
• Patients receiving any other hormonal therapy, including any dose of Megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment; progressive disease (as defined above) must be documented after discontinuation of the hormonal therapy
• Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication at the discretion of the treating physician; however, patients are not allowed to initiate bisphosphonate therapy within 4 weeks prior to starting therapy or throughout the study
• No prior systemic chemotherapy for CRPC; prior neoadjuvant and adjuvant chemotherapy are allowed when completed at least 12 months prior to enrollment
• No use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
• No prior use of IGF-1R inhibitors (monoclonal antibody or small molecule)
• No palliative radiation therapy to bone metastasis or radionuclide therapy for treatment of metastatic CRPC within 4 weeks of Cycle 1 Day 1
• Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine are prohibited
• Other less potent CYP1A2 inhibitors/inducers are not excluded
• Supplements or complementary medicine/botanicals are not permitted while on protocol therapy, except for any combination of the following:
• Conventional multivitamin supplements
• Selenium
• Lycopene
• Soy supplements
• The use of concomitant steroids is not allowed unless patients are receiving physiological replacement disease for documented adrenal insufficiency
• Use of drugs that have a known risk of causing Torsades de Pointes (TdP) are prohibited within 14 days prior to study enrollment