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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Advanced Cancers

Treatments: Drug: Ridaforolimus Intravenous (IV) Infusion; Drug: Ridaforolimus Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00836927

8669-038

MK-8669-038 (Other Identifier)

AP23573-08-901 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 5 patient groups

Ridaforolimus 10 mg Days 1-5

Experimental group

Description:

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.

Treatment:

Drug: Ridaforolimus Tablet

Drug: Ridaforolimus Intravenous (IV) Infusion

Ridaforolimus 10 mg Days 1-6

Experimental group

Description:

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.

Treatment:

Drug: Ridaforolimus Tablet

Drug: Ridaforolimus Intravenous (IV) Infusion

Ridaforolimus 20 mg Days 1-5

Experimental group

Description:

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.

Treatment:

Drug: Ridaforolimus Tablet

Drug: Ridaforolimus Intravenous (IV) Infusion

Ridaforolimus 30 mg Days 1-5

Experimental group

Description:

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.

Treatment:

Drug: Ridaforolimus Tablet

Drug: Ridaforolimus Intravenous (IV) Infusion

Ridaforolimus 40 mg Days 1-5

Experimental group

Description:

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.

Treatment:

Drug: Ridaforolimus Tablet

Drug: Ridaforolimus Intravenous (IV) Infusion