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OpenTrials
Completed

NCT Number: NCT00730379

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

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Ariad Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 8, 2008
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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