MK-0646 Insulin Growth Factor 1 Receptor Antibody in Stage IIIb or IV Metastatic Non-Squamous Lung Cancer (IMPACT)
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|ClinicalTrials.gov Identifier: NCT00799240|
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : November 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Arm A: Pemetrexed Cisplatin Drug: Arm B Pemetrexed, Cisplatin and MK-0646||Phase 2|
Insulin-like Growth factor 1 receptor (IGF-1R) is a tyrosine kinase receptor that regulates cell growth, proliferation and apoptosis.(4) Increased IGF1 signaling results in upregulation of proliferation and inhibition of apoptosis through RAF and PI3K pathways.(5) Several types of cancer, including non-small cell lung cancer, express IGF-1R and its ligand. The sequestration of IGF by IGF binding protein was associated with improved survival in patients with resected stage I lung cancer.(6) High expression of IGF-1R is associated with poor survival in surgically resected stage I lung cancer, specifically adenocarcinoma subtype. Patients with adenocarcinoma and never smoker had higher expression of IGF-1R vs. squamous cell carcinoma and smokers.(7). Low IGF-1R expression was associated with significant improvement in survival in the adenocarcinoma lung cancer but there was a lack of correlation between expression of IGF1R and survival in patients with squamous cell histology.
Monoclonal antibodies target the extracellular domain of IGF-IR and small molecules inhibit IGF-1R kinase. This is a potential new strategy in the treatment of lung cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MK-0646 IMPACT Study: MK-0646, Insulin Growth Factor 1 Receptor Antibody in Stage IIIB or IV Metastatic Non-Squamous Lung Cancer, Combined With Pemetrexed (Alimta) and Cisplatin, a Randomized Phase II Trial.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||July 2014|
Active Comparator: Arm A Pemetrexed Cisplatin
Arm A: Pemetrexed, cisplatin: pemetrexed and cisplatin chemotherapy at standard doses given IV every 21 days. Patients will be treated for a maximum of 6 cycles.
Drug: Arm A: Pemetrexed Cisplatin
Pemetrexed: 500mg/m2 IV on day 1 and Cisplatin: 75 mg/m2 IV on day 1 every 21 days x 6 cycles.
Other Name: MK-0646
Experimental: Arm B Permetrexed, Cisplatin, MK-0646
Pemetrexed and cisplatin chemotherapy at standard doses given IV every 21 days in combination with MK-0646 given IV, 10 mg/Kg, Days 1, 8 and 15 weekly
Drug: Arm B Pemetrexed, Cisplatin and MK-0646
Pemetrexed 500 mg/m2 IV on Day 1 and Cisplatin 75 mg/m2 IV on Day 1 every 21 days for 6 cycles in combination with MK-0646 will be given IV, 10 mg/KG, Days 1, 8 and 15 weekly.
Other Name: MK-0646
- Compare response rate between the two arms. [ Time Frame: 31 months ]
- Progression-free survival, overall survival and Toxicity profile [ Time Frame: 31 months ]
- Exploratory Objectives: Assess biomarkers of Pemetrexed, IGF-1R and immunogenicity of MK-0646. [ Time Frame: 31 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799240
|United States, Kansas|
|Hutchinson Clinic, PA|
|Hutchinson, Kansas, United States, 67502|
|Kansas University Cancer Center|
|Kansas City, Kansas, United States, 66160|
|Stormont Vail Healthcare|
|Topeka, Kansas, United States, 66606|
|United States, Missouri|
|VA Medical Center|
|Kansas City, Missouri, United States, 64128|
|Principal Investigator:||Chao H Huang, MD, FACP||University of Kansas Medical Center|