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

Primary Purpose

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

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

PF-06459988

About this trial

This is an interventional basic science trial for Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC focused on measuring NSCLC, Non-Small Cell Lung Cancer, EGFRm, Epidermal Grown Factor Receptor mutation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single agent - study drug

Arm Description

The study will evaluate single-agent PF-06459988

Outcomes

Primary Outcome Measures

Number of participants with Dose-limiting toxicities (DLT) (phase 1)

The target probability of DLT at MTD will be 30%

Number of Participants With Objective Response (phase 2)

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

Number of Participants With Objective Response for those patients with measurable disease (phase 1)

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

Progression-Free Survival (PFS) - Phase 2

The period from study entry until disease progression, death or date of last contact.

Full Information

NCT ID

NCT02297425

First Posted

November 14, 2014

Last Updated

January 9, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02297425

Brief Title

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

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Withdrawn

Study Start Date

January 2015 (undefined)

Primary Completion Date

March 2018 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

NSCLC, Non-Small Cell Lung Cancer, EGFRm, Epidermal Grown Factor Receptor mutation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single agent - study drug

Arm Type

Experimental

Arm Description

The study will evaluate single-agent PF-06459988

Intervention Type

Drug

Intervention Name(s)

PF-06459988

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with Dose-limiting toxicities (DLT) (phase 1)

Description

The target probability of DLT at MTD will be 30%

Time Frame

up to 21 days

Title

Number of Participants With Objective Response (phase 2)

Description

Time Frame

Time from first dose of study drug to objective response of CR or PR up to 24 months

Secondary Outcome Measure Information:

Title

Number of Participants With Objective Response for those patients with measurable disease (phase 1)

Description

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

Time Frame

time from first dose of study drug until objective response of CR or PR up to 24 months

Title

Progression-Free Survival (PFS) - Phase 2

Description

The period from study entry until disease progression, death or date of last contact.

Time Frame

time from first dose of study drug until Disease Progression or death (whichever first) up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7711001&StudyName=A%20Study%20For%20Patients%20With%20EGFRm%20%28Epidermal%20Growth%20Factor%20Receptor%20Mutant%29%20Lung%20Cancer

Description

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

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