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

NCT00836927 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: 8669-038AP23573-08-901MK-8669-038
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced an Adverse Event

  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.

  Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)

• Number of Participants Who Discontinued Study Drug Due to an Adverse Event

  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.

  Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)

• Overall Survival (OS)

  Up to approximately 2991 days (through data cut-off date of 03 Apr 2017)

• Duration of Response (DOR)

  Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)

Study Arms (5)

Ridaforolimus 10 mg Days 1-5

EXPERIMENTAL

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; Drug: Ridaforolimus Intravenous (IV) Infusion

Ridaforolimus 10 mg Days 1-6

EXPERIMENTAL

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; Drug: Ridaforolimus Intravenous (IV) Infusion

Ridaforolimus 20 mg Days 1-5

EXPERIMENTAL

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; Drug: Ridaforolimus Intravenous (IV) Infusion

Ridaforolimus 30 mg Days 1-5

EXPERIMENTAL

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; Drug: Ridaforolimus Intravenous (IV) Infusion

Ridaforolimus 40 mg Days 1-5

EXPERIMENTAL

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; Drug: Ridaforolimus Intravenous (IV) Infusion

Interventions

Ridaforolimus Tablet DRUG

Ridaforolimus 10 mg oral tablet

Also known as: AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009

Ridaforolimus 10 mg Days 1-5; Ridaforolimus 10 mg Days 1-6; Ridaforolimus 20 mg Days 1-5; Ridaforolimus 30 mg Days 1-5; Ridaforolimus 40 mg Days 1-5

Ridaforolimus Intravenous (IV) Infusion 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).

Also known as: AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009

Ridaforolimus 10 mg Days 1-5; Ridaforolimus 10 mg Days 1-6; Ridaforolimus 20 mg Days 1-5; Ridaforolimus 30 mg Days 1-5; Ridaforolimus 40 mg Days 1-5

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Ariad Pharmaceuticals: collaborator

MeSH Terms

Interventions

ridaforolimus

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: February 1, 2009
• Primary Completion: April 3, 2017
• Study Completion: February 4, 2018
• Last Updated: February 18, 2019
• Results First Posted: May 3, 2018

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share