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

February 9, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ridaforolimus (MK8669) + dalotuzumab (MK0646)
Drug: Comparator: ridaforolimus + dalotuzumab
Starting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.
Time Frame: MTD from Day 1 to Day 28 in Cycle 1 for disease progression
MTD from Day 1 to Day 28 in Cycle 1 for disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab
Time Frame: At prescribed timepoints as defined in the protocol
At prescribed timepoints as defined in the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Ariad Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 8669-004
  • 2008_538

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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