AzTrials
AzTrials

Prostate CancerPhase 2NCT00110188

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

A Phase 2 study testing ridaforolimus in people with Prostate Cancer, run by Merck Sharp & Dohme LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
ridaforolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
4 sitesUnited States
Study dates
May 2005to Aug 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Beth Israel Deaconess Medical Center/MGH/DFCI

    Boston, Massachusetts, 02215

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Louis Warchaw Prostate Cancer Center, Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Wisconsin, Madison, WI

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: A Phase II Study of the Efficacy and Safety of AP23573 in Patients With Taxane-Resistant Androgen-Independent Prostate Cancer (AIPC)

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

Read the detailed description

The primary objective of this phase II study is to assess the anti-cancer activity of weekly ridaforolimus administration in participants with taxane-resistant AIPC. Other objectives include evaluating experimental parameters that may predict or indicate response to mTOR inhibition, such as effects on plasma VEGF, markers of tumoral PI3K/mTOR-pathway activity, and proteomic analysis. The inclusion of these evaluations in this trial may provide insight into the identification of markers that may be helpful in optimizing ridaforolimus treatment and in identifying patients with ridaforolimus-sensitive tumors.

Conditions
Prostate Cancer
Being tested
ridaforolimus
Keywords
prostate, cancer
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ridaforolimusDrug

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

Study groups in NCT00110188
Study groupRoleWhat they receive
RidaforolimusExperimental50 mg of ridaforolimis intravenously over 30 minutes, weekly
Receives: Drug: ridaforolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 24 months

Secondary outcomes (8)

  1. Number of Participants Experiencing at Least One Adverse Event

    Measured: Up to 25 months

  2. Change from Baseline in Prostate-Specific Antigen (PSA)

    Measured: Baseline and up to 24 months

  3. Time to Tumor Progression (TTP)

    Measured: Up to 24 months

  4. Progression-Free Survival (PFS)

    Measured: Up to 24 months

  5. Overall Survival (OS)

    Measured: Up to 24 months

  6. Duration of Response (DOR)

    Measured: Up to 24 months

  7. Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score

    Measured: Baseline and up to 24 months

  8. Change from Baseline in Plasma Vascular Endothelial Growth Factor (VEGF)

    Measured: Baseline and Day 28 of Cycles 1 and 2 (Up to 56 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionApr 2007
  4. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00110188
Sponsor's protocol ID
8669-017
Other IDs
AP23573-04-204
Status last verified
Nov 2015
First submitted
4 May 2005
Last updated
20 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22695254

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ridaforolimus in people with Prostate Cancer, run by Merck Sharp & Dohme LLC at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response (BOR) per Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00110188, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in