Status:
WITHDRAWN
A Study For Patients With EGFRm (Epidermal Growth Factor Receptor Mutant) Lung Cancer
Lead Sponsor:
Pfizer
Conditions:
Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase 1 - open label, multi-center, non-randomized, safety, pharmacokinetic and pharmacodynamics dose escalation study of PF-06459988 as a single agent in patients with advance EGFRm NSCLC (del 19, L8...
Eligibility Criteria
Inclusion
- Evidence of histological or cytologically confirmed diagnosis of locally advanced or metastatic EGFRm (del19 or L858R) NSCLC that is resistant to standard therapy. Patients must have progressed on treatment with an EGFR TKI, and may have also received other line of therapy.
- Tissue available (formalin fixed paraffin embedded (FFPE) block or 10 unstained sections (5 micron)
- Patients must be willing to participate in additional PK studies as required (cohort dependent); patients will be informed of which PK studies are required prior to consenting for study participation
- Adequate Bone Marrow Function (Complete Blood Count laboratory test results)
- Adequate Liver Function (Laboratory test)
Exclusion
- Previously diagnosed brain metastases, unless the patient has completed their treatment and has recovered from the acute effects of radiation therapy or surgery prior to the study registration, have discontinued corticosteroid treatment for these metastases for at least 2 weeks and are neurologically stable
- Systemic anti-cancer therapy within 4 weeks of starting study treatment excluding EGFR TKIs. Patients on EGFR TKIs must discontinue the agent for a minimum of 5 days prior to starting study drug
- Hypertension that cannot be controlled by medication (150/100 mmHg despite optimal medical therapy).
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02297425
Start Date
January 1 2015
End Date
March 1 2018
Last Update
January 12 2015
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