Clinical trial NCT02297425: A Study For Patients With EGFRm (Epidermal Growth Factor Receptor Mutant) Lung Cancer
Official title: Phase 1/2 Open Label Study Of Pf 06459988 (Epidermal Growth Factor Receptor T790m Inhibitor) In Patients With Advanced Epidermal Growth Factor Receptor Mutant (Del 19 Or L858r + - T790m) Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC
Keywords: NSCLC, Non-Small Cell Lung Cancer, EGFRm, Epidermal Grown Factor Receptor mutation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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, 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of participants with Dose-limiting toxicities (DLT) (phase 1)
timeFrame: up to 21 days
measure: Number of Participants With Objective Response (phase 2)
timeFrame: Time from first dose of study drug to objective response of CR or PR up to 24 months
Secondary outcomes:
measure: Number of Participants With Objective Response for those patients with measurable disease (phase 1)
timeFrame: time from first dose of study drug until objective response of CR or PR up to 24 months
measure: Progression-Free Survival (PFS) - Phase 2
timeFrame: time from first dose of study drug until Disease Progression or death (whichever first) up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: