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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730379
• Other study ID #: 8669-004
• Secondary ID: 2008_538
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2008
• Last updated: February 9, 2015
• Start date: July 2008
• Est. completion date: November 2010

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Ariad Pharmaceuticals

References & Publications (1)

Di Cosimo S, Sathyanarayanan S, Bendell JC, Cervantes A, Stein MN, Braña 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No