EUCTR2013-004482-14-ESActive, not recruitingPhase 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 enrollmentStarted: May 12, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 211
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •- Presence of at least one measurable lesion according to RECIST v1.1
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 139
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
- •? Bone marrow function
- •? Absolute Neutrophil Count (ANC) <1.5 x 109/L
- •? Hemoglobin (Hgb) <9 g/dL
- •? Platelets <100 x 109/L
- •? Hepatic and renal function
- •? Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome total bilirubin >2.5 x upper limit of normal (ULN).
- •? Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN
- •- Patients with tumor involvement of the liver must have AST and/or ALT >5 x ULN
- •? Serum creatinine >1.5 x ULN and/or measured creatinine clearance <75% LLN - Patients receiving treatment with medications that are known to be 1) strong inhibitors or inducers of CYP3A4/5; 2) CYP2D6 substrate with narrow therapeutic index
- •Other protocol-defined exclusion criteria may apply
Investigators
Similar Trials
Active, not recruiting
Phase 1
An interventional study of oral EGF816 in adult patients with EGFRmut solid malignanciesSolid tumorsMedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864EUCTR2013-004482-14-DEovartis Pharma Services AG500
Active, not recruiting
Phase 1
An interventional study of oral EGF816 in adult patients with EGFRmut solid malignanciesSolid tumorsMedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864EUCTR2013-004482-14-NLovartis Pharma Services AG211
Completed
Not Applicable
A phase I/II, multicenter, open-label study of EGFRmut-TKI EGF816, administered orally in adult patients with EGFRmut solid malignancies (CEGF816X2101)1003866610029107non-small cell lung cancerlung cancerNL-OMON52991Antoni van Leeuwenhoek Ziekenhuis5
Active, not recruiting
Not Applicable
An interventional study of oral EGF816 in adult patients with EGFRmut solid malignanciesSolid tumorsMedDRA version: 18.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864EUCTR2013-004482-14-FRovartis Pharma AG211
Active, not recruiting
Phase 1
An interventional study of oral EGF816 in adult patients with EGFRmut solid malignanciesSolid tumorsMedDRA version: 19.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864EUCTR2013-004482-14-ITovartis Pharma Services AG500