EUCTR2013-004482-14-ES
Active, not recruiting
Phase 1
A phase I/II, multicenter, open-label study of EGFRmut?TKI EGF816,administered orally in adult patients with EGFRmut solid malignancies
ovartis Farmacéutica, S.A.0 sites211 target enrollmentMay 12, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Solid tumors
- Sponsor
- ovartis Farmacéutica, S.A.
- Enrollment
- 211
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Written informed consent must be obtained prior to any screening
- •\-ALL PATIENTS PARTICIPATING IN THIS CLINICAL TRIAL MUST HAVE RECURRED OR PROGRESSED FOLLOWING STANDARD THERAPY, UNLESS NO STANDARD THERAPY CURRENTLY EXISTS, IS TOLERATED OR APPROPRIATE
- •ADDITIONALLY FOR PHASE I:
- •\- PATIENTS MUST HAVE NSCLC HARBORING A DOCUMENTED EGFR T790M MUTATION
- •ADDITIONALLY FOR PHASE II:
- •\- Group 1: patients must have advanced NSCLC with EGFR mutation (L858R or ex19del, not T790M) AND ARE INTOLERANT TO AN APPROVED EGFR TKI (E.G., ERLOTINIB, GEFITINIB, AFATINIB); AND/OR FOR WHOM THESE DRUGS ARE NOT APPROPRIATE.
- •\- Group 2: patients must have advanced NSCLC with an acquired T790M EGFR mutation
- •\- Group 3: patients must have advanced NSCLC with a de novo T790M EGFR mutation.
- •\- Group 4: patients must have an advanced solid tumor harboring any EGFR mutation and NOT be otherwise eligible for groups 1\-3
- •\- ECOG performance status ? 2
Exclusion Criteria
- •Phase I part only:
- •\- Patient have received more than 3 previous anti\-neoplastic therapies in the advanced setting
- •Phase II part only:
- •\- Group 1: More than total of 3 previous anti\-neoplastic treatments in the advanced setting
- •\- Group 2: More than total of 2 previous anti\-neoplastic therapies in theadvanced setting
- •\- Group 3: More than total of 2 previous anti\-neoplastic therapies in the advanced setting
- •\- Group 4: More than total of 3 previous anti\-neoplastic treatments in the advanced setting.
- •\- Patients with brain metastases
- •\- Any medical condition that would, in the investigator's judgment,prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- •\- Patient have out of range laboratory values defined as
Outcomes
Primary Outcomes
Not specified
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