A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: Comparator: ridaforolimus + dalotuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00730379

2008_538

8669-004

Details and patient eligibility

About

This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.

Full description

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

Enrollment

87 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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