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CASE 6810   |   CC00107
A Phase 2 Study of OSI-906 in Patients with Asymptomatic (Non-Opioid Requiring) Metastatic Castrate Resistant Prostate Cancer

Main Campus
Phase 2

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  1. Primary Objectives
    • To evaluate the clinical efficacy of OSI-906 in patients with asymptomatic or mildly symptomatic (non-Opioid requiring) CRPC with regards to:
      • Time to PSA progression based on Prostate cancer Working Group (PCWG2) criteria.
      • PSA response (Proportion of patients achieving a PSA decline ≥ 50% according to PCWG2 criteria in patients receiving OSI-906.
      • Overall response rate (ORR) in patients with RECIST-defined measurable disease receiving OSI-906.
  2. Secondary Objectives
    • To evaluate the effect of OSI-906 on time-to opiate use for cancer pain.
    • To evaluate the effect of OSI-906 on radiographic progression-free survival (rPFS) patients with asymptomatic or mildly symptomatic (non-Opioid requiring) CRPC.
    • To evaluate the overall survival (OS) of patients with asymptomatic or mildly symptomatic (non-Opiod requiring) CRPC receiving OSI-906.
    • To further evaluate the safety of OSI-906 in patients with patients with asymptomatic or mildly symptomatic (non-Opiod requiring) CRPC.
  3. Exporatory Objectives
    • To describe the effects of OSI-906 in the levels of androstenedione, dehydroepiandrostenedione, dehydropiandrostendione-sulfate, pIGF-IR and p-IR.
    • To describe the effects of OSI-906 in the levels of TGF-b1, IL-6, TNF-a, and MCP-1 as markers of metastatic progression.
    • To describe the effects of OSI-906 on the number of circulating tumor (CTCs) and endothelial cells (CECs)
    • To use RNA extracted from CTCs to evaluate effects on downstream targets of IGF-1R signaling after OSI-906 treatment.
    • To measure the effect of OSI-906 on the expression of IGF-1R on circulating tumor cells (CTCs).

Inclusion Criteria
  1. Understand and voluntarily sign an informed consent form.
  2. Age ≥18 years at the time of signing the informed consent form.
  3. Histologically confirmed adenocarcinoma of the prostate.
  4. Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with LHRH agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study.
  5. Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. If lymph node metastasis is the only evidence of metastasis, it must be > 2 cm in diameter.
  6. Prostate cancer progression documented by PSA according to PCWG2 (Appendix 1) or radiographic progression according to modified RECIST criteria.
  7. Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic. Appendix 2
  8. Patients who received combined androgen blockade or received second-line anti-androgen in the context of CRPC must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (≥ 4 weeks since last flutamide, ≥ 6 weeks since last bicalutamide or nilutamide) and have progressive disease according to section 3.1.7.
  9. Prior therapy with ketoconazole and steroids is allowed provided patients have been off treatment for 4 weeks.
  10. 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.
  11. 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.
  12. Prior therapy with Sipuleucel-T is allowed provided patients have documented evidence of disease progression as stated above.
  13. 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.
  14. 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.
  15. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 3)
  16. Patients must have normal organ and marrow function as defined below:
    • Hemoglobin ≥ 10.0 g/dL independent of transfusion
    • Absolute neutrophil count ≥1,500/mcL
    • Platelet count ≥100,000/µL
    • Serum albumin ≥ 3.5 g/dL
    • Serum Creatinine < 1.5 x ULN or a calculated Creatinine clearance ≥ 60 mL/min (Appendix 4)
    • Serum potassium ≥ 3.5 mmol/L
    • Liver function
    • Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert’s disease)
    • AST or ALT < 2.5 x ULN
  17. Able to swallow the study drug.
  18. Life expectancy of at least 6 months.
  19. The effects of OSI-906 on the developing human fetus are unknown. For this reason and because IGF-1R inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

Exclusion Criteria
  1. Prior systemic chemotherapy for CRPC. Prior neoadjuvant and adjuvant chemotherapy are allowed when completed at least 12 months prior to enrollment.
  2. Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1.
  3. Prior use of IGF-1R inhibitors (monoclonal antibody or small molecule)
  4. Palliative radiation therapy to bone metastasis or radionuclide therapy for treatment of metastatic CRPC within 4 weeks of Cycle 1 Day 1.
  5. The use of concomitant steroids is not allowed unless patients are receiving physiological replacement disease for documented adrenal insufficiency.
  6. History of clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline.
  7. Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months.
  8. 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
    • Patients should review the labels of any other supplements with their treating physician prior to enrollment and discontinue disallowed agents prior to study entry, based on treating physician’s discretion.
  9. Prolonged QTc >470 msec (mean QTc with Bazett’s correction) or history of familial long QT syndrome. QTc(Bazett) = QT/√RR
  10. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  11. Patients with Insulin-dependent Diabetes are excluded
  12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-906.
  13. Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine are prohibited. Other less potent CYP1A2 inhibitors/inducers are not excluded.
  14. Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that would limit compliance with study requirements.
  15. Patients with known history of HIV on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with OSI- 906. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  16. Patients with known infectious Hepatitis A, B or C are also ineligible because of the potential for pharmacokinetic interactions with OSI-906 and its impact in liver function.
  17. Use of drugs that have a known risk of causing Torsades de Pointes (TdP) (’Torsades List’ on; Appendix 6) are prohibited within 14 days prior to study enrollment.
  18. Any condition which, in the opinion of the investigator, would preclude participation in this trial.

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