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A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer

Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009

Inclusion Criteria:

- You must have confirmed metastatic or advanced cancer that has not responded to
standard therapy or where standard therapy does not exist

- In Part C, patients must have a diagnosis of advanced or metastatic colorectal
adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but
no more than three prior systemic therapy treatment regimens

- You must be over the age of 18 years old

- You must have a ECOG status performance of 0 or 1

- You must have good organ function

- You must be willing to have skin and/or tumor biopsies

Exclusion Criteria:

- You have had cancer treatment within 4 weeks prior to entering the study or you still
have bad side effects from previous therapies

- You have an active infection that requires treatment

- You are HIV positive or have a history of Hepatitis B or C

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.

Outcome Time Frame:

MTD from Day 1 to Day 28 in Cycle 1 for disease progression

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

November 2010

Related Keywords:

  • Neoplasms
  • Neoplasms