Ridaforolimus (AP23573/MK-8669) in Participants With Taxane-Resistant Androgen-Independent Prostate Cancer (AIPC)(MK-8669-017)

NCT00110188 | Completed Phase 2

• 2 other identifiers: 8669-017AP23573-04-204
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the antitumor activity of weekly ridaforolimus study treatment in participants with taxane-resistant AIPC.

Conditions

Prostate Cancer

Keywords

prostate; cancer

Outcome Measures

Primary Outcomes (1)

• Best Overall Response (BOR) per Response Evaluation Criteria in Solid Tumors (RECIST)

  Up to 24 months

Secondary Outcomes (8)

• Number of Participants Experiencing at Least One Adverse Event

  Up to 25 months

• Change from Baseline in Prostate-Specific Antigen (PSA)

  Baseline and up to 24 months

• Time to Tumor Progression (TTP)

  Up to 24 months

• Progression-Free Survival (PFS)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Study Arms (1)

Ridaforolimus

EXPERIMENTAL

50 mg of ridaforolimis intravenously over 30 minutes, weekly

Drug: ridaforolimus

Interventions

ridaforolimus DRUG

Also known as: deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009

Ridaforolimus

Eligibility Criteria

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

You may qualify if:

• Male patients aged ≥ 18 years with histologically documented adenocarcinoma of the prostate.
• Clinically refractory to hormone therapy (orchiectomy or luteinizing hormone-releasing hormone agonist/antagonist).
• Presence of metastatic prostate cancer that fulfills at least one evaluation category as listed: \* Measurable Disease: Lesion(s) that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan (or otherwise at least twice the reconstruction interval for CT or MRI scans). \*Non-measurable disease: Lesions noted on imaging studies (including metastatic bone lesions on bone scan) or other non-measurable lesions as defined by the modified RECIST criteria. \*Progressive disease following a cytotoxic chemotherapy regimen for prostate cancer.
• Previous treatment with at least one taxane-containing chemotherapy regimen. Patients may have received treatment with not more than 3 additional regimens of cytotoxic chemotherapy prior to study entry.
• Orchiectomy, or castrate levels of testosterone maintained by LHRH agonist/antagonist \< 50 ng/mL.
• Predicted life expectancy \> 12 weeks.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2.
• Adequate renal and hepatic function, defined as: \*Total serum bilirubin ≤ 1.5 x ULN for the institution; \*AST and/or ALT ≤ 3 x ULN for the institution (≤ 5 x ULN if liver metastases are present); \*Serum albumin ≥ 2.5 g/dL; \*Serum creatinine ≤1.5 x ULN for the institution (or a calculated creatinine clearance ≥ 50 mL/min/1.73m2)
• Adequate bone marrow function, defined as: \*ANC ≥ 1.5 x 10\^9/L; \*Platelet count ≥ 100 x 10\^9/L
• Serum cholesterol \< 350 mg/dL and triglycerides \< 400 mg/dL.
• Male patients who are not surgically sterile must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug.
• Able to understand and give written informed consent.

You may not qualify if:

• Presence of active or progressive brain metastases.
• Prior therapy with rapamycin, rapamycin analogues or tacrolimus.
• Prior non-hormonal anticancer treatment (chemotherapy, radiotherapy, immunotherapy, biological response modifiers, signal transduction inhibitors, etc.) within 4 weeks prior to the first dose of ridaforolimus
• Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by NCI toxicity criteria).
• Another primary malignancy within the past three years (except for non-melanoma skin cancer).
• Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug.
• Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin).
• Significant uncontrolled cardiovascular disease.
• Active infection requiring systemic therapy.
• Known HIV infection.
• Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus
• Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study drug.
• Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus
• Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Ariad Pharmaceuticals: collaborator

Study Sites (4)

Louis Warchaw Prostate Cancer Center, Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Beth Israel Deaconess Medical Center/MGH/DFCI

Boston, Massachusetts, 02215, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

University of Wisconsin, Madison, WI

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Amato RJ, Wilding G, Bubley G, Loewy J, Haluska F, Gross ME. Safety and preliminary efficacy analysis of the mTOR inhibitor ridaforolimus in patients with taxane-treated, castration-resistant prostate cancer. Clin Genitourin Cancer. 2012 Dec;10(4):232-8. doi: 10.1016/j.clgc.2012.05.001. Epub 2012 Jun 12.

  PMID: 22695254 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

ridaforolimus

Condition Hierarchy (Ancestors)

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

Study Officials

• Frank Haluska, M.D.

  Ariad Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 4, 2005
• First Posted: May 5, 2005
• Study Start: May 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: August 1, 2007
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

US (4)