A Study For Patients With EGFRm (Epidermal Growth Factor Receptor Mutant) Lung Cancer

Pfizer

Status and phase

Withdrawn

Phase 2

Conditions

Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC

Treatments

Drug: PF-06459988

Study type

Interventional

Funder types

Industry

Identifiers

NCT02297425

B7711001

T790M (Other Identifier)

Details and patient eligibility

About

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, L858R, +/- T790M). The resulting PF-06459988 dose selected from the phase 1 portion will undergo a series of sub-studies to fully characterize the impact of food, antacid and CYP3A4 inhibitors/inducers. The PK studies are in addition to the MTD expansion and will be completed prior to the initiation of Phase 2. Phase 2 is an open label, multi-center single-arm study of PF-06459988 for the assessment of antitumor activity in patients with advanced EGFRm (del 19 or L858R) NSCLC with T790M.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).