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

NCT01533246 | Completed Phase 2 Results

• 5 other identifiers: NCI-2012-00247CDR0000724845CASE 68108872U01CA062502
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA Response Analyzed Using the PCWG2 Definition

  Number of patients with a PSA Response will be evaluated according to the recommendations from National Cancer Institute Prostate-Cancer Working Group 2 (PCWG2) criteria. PSA decline of at least 50% from baseline confirmed by a second measurement at least 4 weeks later.

  12 weeks

Secondary Outcomes (5)

• Incidence of Toxicities Based on CTCAE Version 4.0 Criteria

  Up to 2 years

• Number of Patients With Bidimensional Measurable Disease RECIST-based Response

  Up to 2 years

• Time to PSA Progression (TTPP) Analyzed Using the PCWG2 Definition

  assessed up to 12 weeks

• Overall Survival Based on the RECIST v1.1

  Up to 2 years

• Progression Free Survival

  assessed up to 2 years

Study Arms (1)

Treatment (linsitinib)

EXPERIMENTAL

Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.

Drug: linsitinib; Other: laboratory biomarker analysis

Interventions

linsitinib DRUG

Oral Linsitinib 150mg, twice a day, days 1- 28

Also known as: OSI-906

Treatment (linsitinib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (linsitinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Barata P, Cooney M, Tyler A, Wright J, Dreicer R, Garcia JA. A phase 2 study of OSI-906 (linsitinib, an insulin-like growth factor receptor-1 inhibitor) in patients with asymptomatic or mildly symptomatic (non-opioid requiring) metastatic castrate resistant prostate cancer (CRPC). Invest New Drugs. 2018 Jun;36(3):451-457. doi: 10.1007/s10637-018-0574-0. Epub 2018 Feb 23.

  PMID: 29476383 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

3-(8-amino-1-(2-phenylquinolin-7-yl)imidazo(1,5-a)pyrazin-3-yl)-1-methylcyclobutanol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Jorge Garcia
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

garciaj4@ccf.org

216-444-7774

Study Officials

• Jorge Garcia

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 15, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 13, 2015
• Results First Posted: March 13, 2015

Record last verified: 2013-12

Locations

US (2)