Efficacy and Safety of LGX818 in Patients With Advanced o... | NCT02109653

Studies
Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC

NCT02109653

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Status

Withdrawn

Last Update Posted

Nov 13, 2020Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Non-Small Cell Lung Cancer

Interventions

LGX818

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-005014-34	EudraCT Number

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never started - transferred to Array.

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Nov 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Mar 25, 2014

First Submission Date that Met QC Criteria

Apr 7, 2014

First Posted Date

Apr 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2020

Last Update Posted Date

Nov 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LGX818	Experimental	Adult patients, with confirmed diagnosis of BRAF V600E mutant advanced or metastatic NSCLC who have progressed on or after at least one prior systemic anticancer therapy.	Drug: LGX818

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LGX818	Drug	Oral LGX818 300mg daily	LGX818

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator	up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)	baseline, every 6 weeks up to 24 weeks
Progression-Free Survival (PFS)	PFS determined by investigator and BIRC.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of BRAF V600E mutation in tumor tissue
Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
At least one measurable lesion as defined by RECIST v1.1
Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2

Exclusion Criteria:

Patients with symptomatic Central Nervous System (CNS) metastases
History of leptomeningeal metastases
Prior therapy with a BRAF inhibitor
Patients taking prohibited medication listed in the protocol
Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
Impaired cardiovascular function or clinically significant cardiovascular diseases
Pregnant or lactating women or woman of childbearing potential

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	1-800-718-1021	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago Medical Center SC-2		Chicago	Illinois	60546	United States

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided