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

NCT ID: NCT00836927

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-01
• Study Completion Date: 2018-02-04

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.

Conditions

Advanced Cancers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ridaforolimus Tablet

Intervention Type: DRUG

Ridaforolimus 10 mg oral tablet

Ridaforolimus Intravenous (IV) Infusion

Intervention Type: DRUG

Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).

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.

Group Type: EXPERIMENTAL

Ridaforolimus Tablet

Intervention Type: DRUG

Ridaforolimus 10 mg oral tablet

Ridaforolimus Intravenous (IV) Infusion

Intervention Type: DRUG

Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).

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.

Group Type: EXPERIMENTAL

Ridaforolimus Tablet

Intervention Type: DRUG

Ridaforolimus 10 mg oral tablet

Ridaforolimus Intravenous (IV) Infusion

Intervention Type: DRUG

Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).

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.

Group Type: EXPERIMENTAL

Ridaforolimus Tablet

Intervention Type: DRUG

Ridaforolimus 10 mg oral tablet

Ridaforolimus Intravenous (IV) Infusion

Intervention Type: DRUG

Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).

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.

Group Type: EXPERIMENTAL

Ridaforolimus Tablet

Intervention Type: DRUG

Ridaforolimus 10 mg oral tablet

Ridaforolimus Intravenous (IV) Infusion

Intervention Type: DRUG

Ridaforolimus IV infusion administered once daily for 5 days every 2 weeks in a 28-day cycle (two 2-week courses equals 1 cycle).

Interventions

Ridaforolimus Tablet

Ridaforolimus 10 mg oral tablet

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009; AP23573; MK-8669; ridaforolimus was also known as deforolimus until May 2009

Eligibility 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

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ariad Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AP23573-08-901

Identifier Type: OTHER

Identifier Source: secondary_id

MK-8669-038

Identifier Type: OTHER

Identifier Source: secondary_id

8669-038

Identifier Type: -

Identifier Source: org_study_id