Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112372
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2005-06-02
Brief Title:
Study of Oral Ridaforolimus AP23573 MK-8669 to Treat Patients With Refractory or Advanced Malignancies MK-8669-016 AM4COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase IIIa Sequential Cohort Dose Escalation Trial to Determine the Safety Tolerability and Maximum Tolerated Dose of AP23573 When Administered Orally in Patients With Refractory or Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this current phase I trial is to study the safety and tolerability of an orally administered dosage form of ridaforolimus This will be accomplished by an ascending dose study of several dosage regimens in patients with advanced malignancies
Detailed Description:
The advent of oral anticancer therapy has created a means to reduce dependency on a system for treating cancer that relies on hospital-based services to administer treatment While known disadvantages of oral therapies such as potential variable absorption unpredictable bioavailability and sometimes poor patient compliance pose challenges the use of orally administered compounds permits investigation of alternative or varied dose regimens which may ultimately enhance overall patient care
Ridaforolimus is currently being studied in phase 1 and phase II clinical trials in patients with advanced cancers Thus far these trials have demonstrated that ridaforolimus has a favorable safety profile and possesses anticancer activity when administered as a 30-minute intravenous IV infusion daily x 5 every-two-weeks or on a weekly schedule The primary objective of this current phase I trial is to study the safety and tolerability of an orally administered dosage form of ridaforolimus This will be accomplished by an ascending dose study of several dosage regimens in patients with advanced malignancies
Ridaforolimus is currently being studied in phase 1 and phase II clinical trials in patients with advanced cancers Thus far these trials have demonstrated that ridaforolimus has a favorable safety profile and possesses anticancer activity when administered as a 30-minute intravenous IV infusion daily x 5 every-two-weeks or on a weekly schedule The primary objective of this current phase I trial is to study the safety and tolerability of an orally administered dosage form of ridaforolimus This will be accomplished by an ascending dose study of several dosage regimens in patients with advanced malignancies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AP23573-05-106 | None | None | None |