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Extension Trial of Deforolimus in Patients With Advanced Cancer (8669-038)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00836927
First received: February 3, 2009
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

To describe the long-term safety of deforolimus in patients for whom a clinical benefit has been established in a prior parent trial with deforolimus and/or in those who remain in long-term follow-up.


Condition Intervention
Advanced Cancers
 Drug: ridaforolimus

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Safety and tolerability of long-term deforolimus [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: February 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral or IV deforolimus, as described in the parent protocol. If the parent protocol involves a combination of deforolimus with one or several other drugs, the additional drug(s) may be continued as described in the parent protocol.
 Drug: ridaforolimus
Oral or IV deforolimus, as described in the parent protocol. If the parent protocol involves a combination of deforolimus with one or several other drugs, the additional drug(s) may be continued as described in the parent protocol.
Other Names:
  • deforolimus
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have participated on a deforolimus parent trial
  • Patients must have derived a clinical benefit from the parent trial
  • Patient is not on any other anti-cancer treatment(s) unless the therapy was allowed on the parent protocol
  • ECOG performance status less than or equal to 2 if the patient is scheduled to receive treatment with deforolimus; no requirement if the patient is included for follow-up purposes only
  • Patients of childbearing potential must have a negative pregnancy test within 7 days prior to screening and must use approved contraceptive from screening until 30 days after the last dose of study drug
  • Signed informed consent

Exclusion Criteria:

  • Has not participated on a parent trial
  • Women who are to receive study drug who are pregnant or lactating
  • Any condition in the Investigator's judgment that renders the patient unable to fully understand and provide informed consent and/or comply with the protocol
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00836927     History of Changes
Other Study ID Numbers: AP23573-08-901
Study First Received: February 3, 2009
Last Updated: November 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013