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

• Status: Terminated
• Trial end date: 2018-02-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Ariad Pharmaceuticals
• Treatments: Sirolimus

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