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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT02297425
Pfizer
Withdrawn
A Study For Patients With EGFRm (Epidermal Growth Factor Receptor Mutant) Lung Cancer

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A Study For Patients With EGFRm (Epidermal Growth Factor Receptor Mutant) Lung Cancer
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC
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
Experimental: Single agent - study drug
The study will evaluate single-agent PF-06459988
Intervention: Drug: PF-06459988
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2018
March 2018   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02297425
B7711001
T790M ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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