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A Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (0646-007)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00654420
First received: March 26, 2008
Last updated: April 24, 2012
Last verified: April 2012

March 26, 2008
April 24, 2012
March 2008
November 2009   (final data collection date for primary outcome measure)
Safety and tolerability of the combination treatment; progression-free survival will be assessed using physical examinations, vital signs, ECOG performance status, complete blood count with differential and platelets, serum chemistry, adverse experience [ Time Frame: After each dose of study drug ] [ Designated as safety issue: Yes ]
Safety and tolerability of the combination treatment; progression-free survival [ Time Frame: After each dose of study drug ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00654420 on ClinicalTrials.gov Archive Site
response rate and overall survival [ Time Frame: After each dose of study drug ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (0646-007)
An Open Label, Randomized Phase I/IIa Trial Evaluating MK0646 in Combination With Erlotinib for Patients With Recurrent Non-Small Cell Lung Cancer

This study will look for the highest tolerated dose of dalotuzumab given in combination with erlotinib. The study will also investigate how well dalotuzumab works in conjunction with erlotinib at treating recurrent non-small cell lung cancer.

  • Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the IGF-1R
  • Dalotuzumab may act through

    • Inhibition of IGF-1-mediated cell signaling to cause reductions in tumor growth and spread
    • Antibody dependent cell-mediated cytotoxicity
    • In preclinical studies, dalotuzumab improved the activity of an anti-EGFR mAb and the activity of Erlotinib, a small molecule inhibitor of EGFR

Trial Duration of Treatment: Subjects will continue on the study for as long as their disease is not progressing and they do not have unmanageable side effects from the treatment.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-small-cell Lung
  • Drug: Comparator: Dalotuzumab (MK0646)
    Dalotuzumab IV infusion over 60 minutes at 5 mg/kg weekly and then dose escalate to 10 mg/kg weekly following the dose limiting toxicity (DLT) then the dose will be considered. Phase II will be IV infusion over 60 minutes at 5 mg/kg weekly.
  • Drug: Comparator: erlotinib
    Erlotinib will be administrated orally by mouth (PO) at 150 mg daily.
Experimental: Phase 1 & 2
The Phase I part of the study will be a safety assessment of erlotinib in combination with dalotuzumab. Erlotinib will be administrated orally by mouth (PO) at 150 mg daily, and dalotuzumab IV at 5 mg/kg weekly and then dose escalate to 10 mg/kg weekly following the a dose limiting toxicity (DLT) then the dose will be considered. Phase II will be IV at 5 mg/kg weekly. The minimum Phase II dose of dalotuzumab will be 5 mg/kg weekly. If the 5 mg/kg dose is not tolerated, then Phase I will be terminated and Phase II will not be conducted.
Interventions:
  • Drug: Comparator: Dalotuzumab (MK0646)
  • Drug: Comparator: erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
February 2012
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer that has relapsed after chemotherapy/chemoratiotherapy.
  • Subject has had at least one chemotherapy regimen for recurrent or metastatic disease.
  • Subject is 18 years of age or older
  • Subject has a performance status of 0-2 on ECOG scale.
  • Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

  • Subject has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
  • Subject has not recovered from adverse events from previous therapy within 4 weeks
  • Subject has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
  • Subject has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
  • Subject has had more than 2 systemic chemotherapies for metastatic disease
  • Subject has not completed radiotherapy with complete resolution of toxicities at least 2 weeks before starting in the study
  • Subject is taking part in another clinical study
  • Subject has a primary central nervous system tumor
  • Subject abuses drugs or alcohol
  • Subject is pregnant or breastfeeding
  • Subject is HIV positive
  • Subject has a history of hepatitis B or C
  • Subject is using growth hormone or growth hormone inhibitors
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00654420
2007_605, MK0646-007
Not Provided
Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP