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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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00836927
First received: February 3, 2009
Last updated: July 15, 2014
Last verified: July 2014
  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

Further study details as provided by Merck Sharp & Dohme Corp.:

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 2014
Estimated Primary Completion Date: October 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00836927     History of Changes
Other Study ID Numbers: 8669-038, AP23573-08-901
Study First Received: February 3, 2009
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014