NCT01582997

Brief Summary

BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This study will be designed to assess safety, tolerability, single and repeat dose PK profile and preliminary efficacy of GSK2118436 in Japanese subjects with BRAF V600 mutation positive solid tumors using continuous daily dosing schedule.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started May 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 23, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

May 11, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2015

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

April 5, 2012

Last Update Submit

November 8, 2017

Conditions

Cancer

Keywords

BRAFAdvance solid tumors

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    Adverse Events will be graded by the investigator according to the NCI-CTCAE (version 4.0)

    First 28 days for Dose-limiting toxicity, Adverse Events for 1 year

Secondary Outcomes (5)

  • Pharmacokinetics (PK) parameters of GSK2118436 and its metabolites including blood concentration, Cmax and AUC

    For 1 year

  • Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    For 1 year

  • Serum levels of cytokines

    For 1 year

  • Expression levels of pERK and Ki67 in tumor tissues if possible

    For 1 year

  • Gene mutation in tumor tissues, including BRAF and KRAS

    For 1 year

Study Arms (1)

Dose Escalation Part

EXPERIMENTAL

Dose escalation will be conducted to assess safety, tolerability, single and repeat dose PK profile and preliminary efficacy of GSK2118436 . The dose may be escalated to the overseas recommended phase III dose.

Drug: GSK2118436

Interventions

GSK2118436DRUG

Dose escalation with GSK2118436 may proceed until the overseas recommended phase III dose.

Dose Escalation Part

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of a solid tumor that is not responsive to standard therapies or for which there is no approved or curative therapy.
  • Subjects must have BRAF V600E or K mutant positive tumors.
  • Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication.
  • Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication.
  • Must have adequate organ function.
  • Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

You may not qualify if:

  • Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery).
  • Use of an investigational anti-cancer drug within 28 days preceding the first dose of GSK2118436.
  • A history of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of complete resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  • History of Human Immunodeficiency Virus (HIV) infection.
  • Certain cardiac abnormalities.
  • Pregnant or lactating female.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Shizuoka, 411-8777, Japan

Location

GSK Investigational Site

Tokyo, 104-0045, Japan

Location

Related Publications (1)

  • Fujiwara Y, Yamazaki N, Kiyohara Y, Yoshikawa S, Yamamoto N, Tsutsumida A, Nokihara H, Namikawa K, Mukaiyama A, Zhang F, Tamura T. Safety, tolerability, and pharmacokinetic profile of dabrafenib in Japanese patients with BRAF V600 mutation-positive solid tumors: a phase 1 study. Invest New Drugs. 2018 Apr;36(2):259-268. doi: 10.1007/s10637-017-0502-8. Epub 2017 Sep 7.

    PMID: 28879519DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

dabrafenib

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 23, 2012

Study Start

May 11, 2012

Primary Completion

August 1, 2014

Study Completion

April 16, 2015

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

JP(2)