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RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

This study has been terminated.
(Low overall response rate)
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00630344
First received: February 28, 2008
Last updated: January 20, 2014
Last verified: January 2014

February 28, 2008
January 20, 2014
February 2008
December 2013   (final data collection date for primary outcome measure)
To Determine the Best Overall Response and Duration of Response, Taking Into Consideration Measurable Disease, Bone Metastases and PSA. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
The primary endpoint of this Phase II study is the best overall response, taking into consideration measurable disease, bone metastases, and PSA. A patient will be considered to have a favorable outcome if PSA declines in the absence of measurable disease without the appearance of new bone lesions, or if a response in measurable disease consistent with RECIST guidelines is observed, without an increase in PSA or the appearance of new bone lesions. Patients with stable disease lasting at least 6 months will also be considered to have favorable outcome.
To determine the best overall response and duration of response, taking into consideration measurable disease, bone metastases and PSA. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00630344 on ClinicalTrials.gov Archive Site
To Characterize the Toxicity Profile of RAD001 in Combination With Standard Dose Bicalutamide in Patients With Androgen Independent Prostate Cancer. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

The goal of this clinical trial is to learn if the study drug RAD001 in combination with Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with Bicalutamide will also be studied. RAD001 has been shown to kill prostate cancer cells. In addition, several hundred kidney and heart transplant patients have been treated with the same main ingredient as in RAD001 for many years.

  • Participants will be given a study medication-dosing calendar for each treatment cycle. Each treatment cycle lasts four weeks during which time participants will take RAD001 and bicalutamide orally, once per day. RAD001 will be provided from the research pharmacy at the hospital and a prescription will be given for bicalutamide to obtain from a local pharmacy.
  • A history, physical exam, and blood tests will be performed every four weeks. An assessment of the tumor by Chest CT scan, chest x-ray, bone scan, and abdomen/pelvis CT or MRI will be performed every 12 weeks.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: RAD001
    Taken orally once daily
  • Drug: Bicalutamide
    Taken orally once daily
Experimental: RAD-001 in combination with bicalutamide
RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
Interventions:
  • Drug: RAD001
  • Drug: Bicalutamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
36
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • Histologically documented prostate cancer
  • Castration resistant prostate cancer defined as two rising PSAs on castration therapy
  • Baseline PSA of 2ns/mL or greater
  • Testosterone of 50ng/mL or less
  • Patients on LHRH agonist/antagonist must continue therapy at the recommended dosing intervals
  • Prior bicalutamide is allowed as long as treatment was for 6 months or longer
  • Metastatic disease is not required
  • Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
  • ECOG Performance Status equal to or less than 2
  • Adequate bone marrow and liver function as outlined by parameters in the protocol

Exclusion Criteria:

  • Prior treatment with any investigational drug within the preceding 4 weeks
  • Prior treatment with an mTOR inhibitor
  • Fasting lipids over the parameters outlined in the protocol
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Other malignancies within the past 3 years except for adequately treated or basal squamous cell carcinomas of the skin
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
  • Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
  • Men able to conceive and unwilling to practice an effective method of birth control
  • Known hypersensitivity to RAD001 or other rapamycins or to its excipients
  • History of noncompliance to medical regimens
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00630344
07-316
Yes
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Novartis Pharmaceuticals
Study Chair: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP