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

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ClinicalTrials.gov Identifier: NCT02297425
Recruitment Status : Withdrawn
First Posted : November 21, 2014
Last Update Posted : January 12, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC Drug: PF-06459988 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : January 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single agent - study drug
The study will evaluate single-agent PF-06459988
 Drug: PF-06459988
The study will evaluate PF-06459988 PO (tablets) continuous daily dosing in 21 day cycles. The starting dose for PF-06459988 will be 50 mg PO daily. The escalation/de-escalation rules will follow the modified toxicity probability interval method with adjustments using the DLT rate and maximum size per dose level of 10 patients


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Dose-limiting toxicities (DLT) (phase 1) [ Time Frame: up to 21 days ]
    The target probability of DLT at MTD will be 30%

  2. Number of Participants With Objective Response (phase 2) [ Time Frame: Time from first dose of study drug to objective response of CR or PR up to 24 months ]
    Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those as noted in the RECIST Criteria: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions


Secondary Outcome Measures :
  1. Number of Participants With Objective Response for those patients with measurable disease (phase 1) [ Time Frame: time from first dose of study drug until objective response of CR or PR up to 24 months ]
    Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those PR are those as noted in the RECIST Criteria: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions

  2. Progression-Free Survival (PFS) - Phase 2 [ Time Frame: time from first dose of study drug until Disease Progression or death (whichever first) up to 24 months ]
    The period from study entry until disease progression, death or date of last contact.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297425


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02297425    
Other Study ID Numbers: B7711001
T790M ( Other Identifier: Alias Study Number )
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: January 12, 2015
Last Verified: January 2015
Keywords provided by Pfizer:
NSCLC, Non-Small Cell Lung Cancer, EGFRm, Epidermal Grown Factor Receptor mutation
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases