An Imaging Phase I B Study Evaluating MK-0646 in Combination with Erlotinib for Patients with Advanced Non-Small Cell Lung Cancer
- Registration Number
- CTRI/2009/091/000139
- Lead Sponsor
- Merck & Co., Inc. One Merck DriveP.O. Box 100Whitehouse Station, NJ, 08889-0100, U.S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 106
Patients must meet all of the following criteria to participate in this study:
1.Patient has histologically or cytologically documented, unresectable, locally advanced or metastatic Stage IIIb/IV NSCLC.
2.Patient has measurable disease (at least one measurable primary or other intrathoracic/supraclavicular lesion ≥2 cm).
3.Patient has archival tumor tissue available (at site or confirmed at an off-site location) prior to drug administration.
4.Patient has had one or two prior systemic chemotherapy regimens for recurrent or metastatic disease.
5.(Part I only) Patient meets either of the following criteria:
a.Female non-smoker with non-squamous histology, who has had one or two prior systemic chemotherapies.
b.Documented EGFR mutation associated with EGFR inhibitor sensitivity, or EGFR gene amplification, regardless of other demographic or clinical characteristics, who has had no more than two prior systemic chemotherapies.
6.(Part II only) Patient has accessible tumor(s) and consents to undergo a tumor core needle biopsy.
7.Patient is male or female, and 18 years of age on the day of signing informed consent.
8.Patient has a performance status 0-2 on the ECOG Performance Scale.
9.Patient must have adequate organ function.
10.Female patient of childbearing potential has a negative serum or urine pregnancy test within 28 days of study enrollment.
11.Male and female patients agree to use adequate contraception during therapy with erlotinib alone or MK-0646 in combination with erlotinib. Note that simultaneous use of two reliable forms of contraception is recommended for the entire study period and ending 28 days after the last dose of study drug.
12.Patient, or the patient?s legal representative, has voluntarily agreed to participate by giving written informed consent.
A patient meeting any of the following criteria is not eligible to participate in this study:
1.Patient who has had chemotherapy within 2 weeks prior to entering the study, or biological therapy such as bevacizumab (Avastin®) within 4 weeks prior to entering the study, or who has not recovered to at least grade 1 or baseline from adverse events due to agents administered prior to entering the study.
2.Patient who has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within the 3 months prior to entering the study.
3.Patient who has received prior EGFR ? tyrosine kinase inhibitor/anti-EGFR mAb therapy or prior IGF1R ? tyrosine kinase inhibitor/anti-IGF1R mAb therapy.
4.Patient is currently participating or has participated in a study with an investigational compound or device within 30 days (or 5 half-lives of the investigational compound) of initial dosing with study drug.
5.Patients with untreated brain metastases or carcinomatous meningitis are excluded. However, patients who have stable CNS metastases for 4 weeks off of corticosteroids, and who are at least 4 weeks from the time of appropriate local therapy for CNS disease are eligible for protocol enrollment.
6.Patient has known hypersensitivity to the components of study drug or its analogs.
7.Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient?s participation for the full duration of the study, or is not in the best interest of the patient to participate.
8.Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
9.Patient has atelectasis that prevents delineation of primary tumor.
10.Patient has post-obstructive pneumonia.
11.Patient has pure bronchoalveolar carcinoma.
12.Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible.
13.Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.
14.Patient is known to be Human Immunodeficiency Virus (HIV)-positive.
15.Patient has active viral hepatitis.
16.Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA <1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, and who is deemed at low risk for recurrence by his/her treating physician.
17.Patient is concurrently using growth hormone (GH), or growth hormone inhibitors.
18.Patient has poorly controlled diabetes mellitus with fasting serum glucose 150 mg/dL at screening visit. This includes patients who are taking steroids that cause fasting serum glucose  150 mg/dL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method