Clinical trial · Interventional

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

NCT00836927CI-TRIAL-00037147terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Cancers	Malignant Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Ridaforolimus Intravenous (IV) Infusion	Drug	Ridaforolimus	ALIAS
Ridaforolimus Tablet	Drug	Ridaforolimus	ALIAS

Design

Arms and outcomes

Arms (5)

type
EXPERIMENTAL
label
Ridaforolimus 10 mg Days 1-5
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.
interventionNames
1. Drug: Ridaforolimus Tablet
2. Drug: Ridaforolimus Intravenous (IV) Infusion
type
EXPERIMENTAL
label
Ridaforolimus 10 mg Days 1-6
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.
interventionNames
1. Drug: Ridaforolimus Tablet
2. Drug: Ridaforolimus Intravenous (IV) Infusion
type

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 1 Year

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.