EUCTR2013-004482-14-NL
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Solid tumors
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 211
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For all patients (unless otherwise specified):
- •1\. Written informed consent obtained prior to any screening procedures
- •2\. Patient (male or female) \= 18 years of age
- •3\. Patients must have histologically or cytologically confirmed locally
- •advanced (stage IIIB not amendable to definitive multi\-modality therapy
- •including surgery) or metastatic (stage IV) EGFR mutant NSCLC
- •AZD9291, CO\-1686, or ASP8273\); No more than 3 prior lines of systemic
- •antineoplastic therapies (including EGFR TKIs) in the advanced setting;
- •3rd\-generation EGFR TKI treatment must be the last prior treatment
- •before study entry.
Exclusion Criteria
- •For all patients (unless otherwise specified):
- •1\. Patients with a history or presence of interstitial lung disease or
- •interstitial pneumonitis, including clinically significant radiation
- •pneumonitis (i.e. affecting activities of daily living or requiring
- •therapeutic intervention)
- •2\. Patients with unstable brain metastases.
- •3\. Presence or History of another malignancy
- •Exception: Patients who have been disease\-free for 3 years, or patients
- •with a history of adequately treated in\-situ carcinoma of the uterine
- •cervix, basal or squamous cell carcinoma, non\-melanomatous cancer of
Outcomes
Primary Outcomes
Not specified
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