Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Sirolimus

Temsirolimus

MTOR Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Immunosuppressive Agents

Immunologic Factors

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.

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.

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.

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.

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.

Ridaforolimus Tablet

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 Intravenous (IV) Infusion

Medical Director

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.

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

An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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.

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.

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.

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.

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.

Ariad Pharmaceuticals

Merck Sharp & Dohme LLC

MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded. All-cause mortality includes deaths not due to an adverse event. Analysis population includes all participants who received any study drug on this extension protocol according to their actual treatment.

Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.

Ridaforolimus 10 mg Days 1-5 (Up to Data Cut-Off)

Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.

Ridaforolimus 10 mg Days 1-6 (Up to Data Cut-Off)

Ridaforolimus 20 mg administered once daily on Days 1-5 per week.

Ridaforolimus 20 mg Days 1-5 (Up to Data Cut-Off)

Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.

Ridaforolimus 30 mg Days 1-5 (Up to Data Cut-Off)

Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.

Ridaforolimus 40 mg Days 1-5 (Up to Data Cut-Off)

Participants remaining on treatment after closure of the study database. Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.

Ridaforolimus 10 mg Days 1-6 (Post Data Cut-Off)

Participants remaining on treatment after closure of the study database. Ridaforolimus 20 mg administered orally once daily on Days 1-5 per week.

Ridaforolimus 20 mg Days 1-5 (Post Data Cut-Off)

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

Total

Age, Continuous

Sex: Female, Male

White

Hispanic or Latino

Race/Ethnicity, Customized

Senior Vice President, Global Clinical Development

All participants who received any study drug on this extension protocol according to their actual treatment.

Number of Participants Who Experienced an Adverse Event

Progression-free Survival (PFS)

Overall Survival (OS)

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

All participants who received any study drug on this extension protocol according to their actual treatment and who experienced a CR or PR.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial