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

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

This phase II trial studies how well linsitinib works in treating patients with asymptomatic or mild symptomatic metastatic prostate cancer. Linsitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT01533246

Run by

National Cancer Institute (NCI)

People needed

17

Starts

2012-02-01

Expected to finish

2012-11-01

Last updated by the study team

2015-03-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate
• Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM); if the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to course 1 Day 1 and must be continued throughout the study
• Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on computed tomography (CT) or magnetic resonance imaging (MRI); if lymph node metastasis is the only evidence of metastasis, it must be ≥ 2 cm in diameter
• Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
• Asymptomatic or mildly symptomatic from prostate cancer; a score of 0-1 on Brief Pain Inventory (BPI)-Short Form (SF) Question #3 (worst pain in last 24 hours) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic
• 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
• No patients with known brain metastases
• Understand and voluntarily sign an informed consent form
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• 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 times upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 60 mL/min
• Serum potassium ≥ 3.5 mmol/L
• Serum bilirubin < 1.5 times ULN (except for patients with documented Gilbert's disease)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 times ULN
• Able to swallow the study drug
• Life expectancy of at least 6 months
• 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
• No history of clinically significant heart disease as evidenced by myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, New York Heart Association (NYHA) Class II-IV heart disease, or cardiac ejection fraction measurement of < 50% at baseline
• No prolonged QTc > 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

Where it is running

• Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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