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

NCT00730379 | Completed Phase 1

• 2 other identifiers: 8669-0042008_538
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

• To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab

  At prescribed timepoints as defined in the protocol

Study Arms (1)

1

EXPERIMENTAL

ridaforolimus (MK8669) + dalotuzumab (MK0646)

Drug: Comparator: ridaforolimus + dalotuzumab

Interventions

Comparator: ridaforolimus + dalotuzumab DRUG

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).

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Ariad Pharmaceuticals: collaborator

Related Publications (1)

• Di Cosimo S, Sathyanarayanan S, Bendell JC, Cervantes A, Stein MN, Brana I, Roda D, Haines BB, Zhang T, Winter CG, Jha S, Xu Y, Frazier J, Klinghoffer RA, Leighton-Swayze A, Song Y, Ebbinghaus S, Baselga J. Combination of the mTOR inhibitor ridaforolimus and the anti-IGF1R monoclonal antibody dalotuzumab: preclinical characterization and phase I clinical trial. Clin Cancer Res. 2015 Jan 1;21(1):49-59. doi: 10.1158/1078-0432.CCR-14-0940. Epub 2014 Oct 15.

  PMID: 25320355 RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

dalotuzumab

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 10, 2015

Record last verified: 2015-02