NCT02974803

Brief Summary

Dabrafenib and trametinib are drugs that are usually given for the treatment of melanoma. Combinations of dabrafenib and trametinib have also been studied and when used together have shown to increase tumour shrinkage in animals compared to either drug alone. Dabrafenib and trametinib have also shown potential to penetrate the blood-brain-barrier when given together and have an effect on brain metastases. Giving these drugs at the same time and then giving brain stereotactic radiosurgery (SRS) may also be preferred in patients with brain metastases

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

6 active sites

Status
terminated

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

November 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 9, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 17, 2021

Completed
Last Updated

August 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2.5 years

First QC Date

November 23, 2016

Results QC Date

May 5, 2021

Last Update Submit

August 18, 2021

Conditions

MelanomaBrain Metastases

Outcome Measures

Primary Outcomes (1)

  • Intracranial Objective Response Rate

    24 months

Secondary Outcomes (4)

  • Extra-cranial Objective Response Rate

    24 months

  • Duration of Response

    24 months

  • Intracranial Progression Free Survival

    24 months

  • Overall Progression Free Survival

    24 months

Other Outcomes (1)

  • Overall Objective Response Rate

    24 months

Study Arms (1)

Dabrafenib and Trametinib

EXPERIMENTAL

Dabrafenib, PO, 150mg BID Continuously Trameteinib, PO 2mg OD Continuously

Drug: DabrafenibDrug: Trametinib

Interventions

DabrafenibDRUG

Dabrafenib 150 mg twice a day until progression or unaccepted toxicity.

Dabrafenib and Trametinib
TrametinibDRUG

Trametinib 2 mg once daily until progression or unaccepted toxicity.

Dabrafenib and Trametinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed melanoma metastatic to brain and determined to be BRAF V600 mutated.
  • Age ≥ 18 years.
  • Karnofsky Performance Status of 70-100 (Appendix I).
  • Patients must have a life expectancy of at least 12 weeks.
  • Presence of measurable disease (i.e. present with at least one measurable CNS lesion per RECIST 1.1).
  • Presence of 1-10 brain metastases as confirmed on a thin slice axial T1 post-gadolinium MRI sequence. The maximum diameter of a single brain lesion should be ≤ 4 cm and presence of a measurable lesion ≥ 1cm based on baseline MRI of brain.
  • All CNS metastases amenable to single fraction SRS and or fractionated SRS. Hemorrhagic lesions are allowed if the treating radiation oncologist deems the lesion amenable to focal SRS.
  • Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
  • Laboratory requirements (within 14 days prior to registration):
  • ANC ≥ 1.2 x 10\^9/L
  • Hemoglobin ≥ 90 g/L
  • Platelet count ≥ 100 x 10\^9/L
  • PT/INR \& PTT ≤ 1.3 x ULN
  • Total bilirubin ≤ 1.5 x ULN
  • AST and ALT ≤ 2.5 x ULN
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

MelanomaBrain Neoplasms

Interventions

dabrafenibtrametinib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Lesely Seymour
Organization
Canadian Cancer Trials Group
lseymour@ctg.queensu.ca
6135336430

Study Officials

  • Arjun Sahgal

    Odette Cancer Centre, Toronto, ON Canada

    STUDY CHAIR

  • Teresa Petrella

    Odette Cancer Centre, Toronto, ON Canada

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 28, 2016

Study Start

February 9, 2018

Primary Completion

July 29, 2020

Study Completion

July 29, 2020

Last Updated

August 20, 2021

Results First Posted

August 17, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)