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Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)

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ClinicalTrials.gov Identifier: NCT00836927
Recruitment Status : Active, not recruiting
First Posted : February 4, 2009
Results First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
To describe the long-term safety of deforolimus (ridaforolimus, MK-8669) in participants for whom a clinical benefit has been established in a prior parent trial (MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054) with deforolimus and/or in those who remain in long-term follow-up.

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: Ridaforolimus Tablet Drug: Ridaforolimus Intravenous (IV) Infusion Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer
Actual Study Start Date : February 1, 2009
Actual Primary Completion Date : April 3, 2017
Estimated Study Completion Date : July 9, 2018

Arm Intervention/treatment
Experimental: Ridaforolimus 10 mg Days 1-5
Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus intravenous (IV) infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
Drug: Ridaforolimus Tablet
Ridaforolimus 10 mg oral tablet
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: Ridaforolimus Intravenous (IV) Infusion
Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Experimental: Ridaforolimus 10 mg Days 1-6
Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
Drug: Ridaforolimus Tablet
Ridaforolimus 10 mg oral tablet
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: Ridaforolimus Intravenous (IV) Infusion
Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Experimental: Ridaforolimus 20 mg Days 1-5
Ridaforolimus 20 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
Drug: Ridaforolimus Tablet
Ridaforolimus 10 mg oral tablet
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: Ridaforolimus Intravenous (IV) Infusion
Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Experimental: Ridaforolimus 30 mg Days 1-5
Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
Drug: Ridaforolimus Tablet
Ridaforolimus 10 mg oral tablet
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: Ridaforolimus Intravenous (IV) Infusion
Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Experimental: Ridaforolimus 40 mg Days 1-5
Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week. Participants may continue ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.
Drug: Ridaforolimus Tablet
Ridaforolimus 10 mg oral tablet
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: Ridaforolimus Intravenous (IV) Infusion
Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).
Other Names:
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009



Primary Outcome Measures :
  1. Number of Participants Who Experienced an Adverse Event [ Time Frame: Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017) ]
    An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who experienced an adverse event is presented.

  2. Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017) ]
    An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who discontinued study drug due to an adverse event is presented.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017) ]
    PFS was defined as the time from randomization to the first documented progressive disease (PD), or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS for all participants is presented in days.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 2991 days (through data cut-off date of 03 Apr 2017) ]
    OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up.

  3. Duration of Response (DOR) [ Time Frame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017) ]
    For participants who demonstrated a confirmed response (Completed Response [CR] or Partial Response [PR]) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have participated on a deforolimus (ridaforolimus) parent trial
  • Must have derived a clinical benefit from the parent trial
  • Is not on any other anti-cancer treatment(s) unless the therapy was allowed on the parent protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 if the participant is scheduled to receive treatment with deforolimus; no requirement if the participant is included for follow-up purposes only
  • Participant 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 participant unable to fully understand and provide informed consent and/or comply with the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836927


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Ariad Pharmaceuticals
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme Corp.:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00836927     History of Changes
Other Study ID Numbers: 8669-038
AP23573-08-901 ( Other Identifier: Ariad Protocol Number )
MK-8669-038 ( Other Identifier: Merck Protocol Number )
First Posted: February 4, 2009    Key Record Dates
Results First Posted: May 3, 2018
Last Update Posted: May 3, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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