E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non Small Cell Lung Cancer |
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E.1.1.1 | Medical condition in easily understood language |
Non Small Cell Lung Cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Phase I: To determine the safety and tolerability of erlotinib in combination with MK-0646 in patients with recurrent NSCLC.
Phase II: To evaluate the effect of the combination of erlotinib and MK-0646 on PFS in patients with recurrent NSCLC.
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E.2.2 | Secondary objectives of the trial |
Radiological: To quantify response rate (RR) by response criteria in solid tumors (RECIST) criteria.
Clinical: To determine overall survival (OS).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age greater than or equal to 18 years
• Histologically/cytologically documented, unresectable, locally advanced, recurrent or relapsed metastatic Stage IIIB/IV NSCLC
• Measurable disease
• ECOG performance status 0-2
• Adequate hematologic, renal, and hepatic function: ANC greater than or equal to 1,500/μl, platelet greater than or equal to 100,000/ μl, Creatinine <1.5mg/ml; T.bilirubin ≤ ULN, AST/ALT ≤ 1.5x ULN, etc.
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E.4 | Principal exclusion criteria |
• Prior EGFR – TKI inhibitor/anti-EGFR mAb therapy is not allowed
• Prior IGF1R - TKI inhibitor/anti-IGF1R mAb therapy is not allowed
• No more than 2 prior systemic therapies
• Patient who has not completed radiotherapy with complete resolution of toxicities at least 2 weeks prior to beginning this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The difference in progression-free survival (PFS) between treatment groups. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation/ Scans should be performed every 6 weeks for the first 48 weeks and thereafter every 3 months.
For amendment 11 we are not evaluating time points for endpoint. |
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E.5.2 | Secondary end point(s) |
Secondary endpoints include OS and RR.
Overall survival (OS): defined as the time from randomization to death due to any cause.
Response rate (RR): defined as the proportion of patients in the analysis population who have complete response (CR) or partial response (PR) during the course of the study.
For amendment 11 we are not evaluating any time points for endpoint. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For (OS) Overall survival, post study evaluations will be done at 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the last dose of study drug. A follow-up contact will be conducted for patients every three months until death, or the cut-off date for the last protocol mandated analysis, whichever occurs first.
For Response rate (RR): Evaluation/ Scans should be performed every 6 weeks for the first 48 weeks and thereafter every 3 months.
For amendment 11 we are not evaluating any time points. Survival follow up will be discontinued. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Brazil |
Canada |
Denmark |
France |
Germany |
Italy |
Netherlands |
Russian Federation |
Spain |
Sweden |
Switzerland |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |