Status:
COMPLETED
A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This open-label, multi-center study will evaluate the safety, tolerability, and pharmacokinetics of RO5212054 \[PLX3603\] in participants with BRAF V600-mutated advanced solid tumors. Cohorts of parti...
Eligibility Criteria
Inclusion
- Advanced solid tumor
- Dose-escalation phase: Histologically confirmed, newly diagnosed or relapsed/ refractory unresectable American Joint Committee on Cancer (AJCC) Stage IIIC or IV disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate liver, renal and bone marrow function
Exclusion
- Participants for whom standard therapy exists and is considered appropriate by the investigator
- Prior treatment with an inhibitor of BRAF (sorafenib allowed)
- Active Central nervous system (CNS) lesions, or history of or known carcinomatous meningitis
- Treatment with any chemotherapy, radiotherapy, immunotherapy or investigational agent within 28 days prior to first dose of study drug
- Anticipated or ongoing anti-cancer therapies other than those administered in this study
- Serious cardiovascular illness within the 6 months prior to study drug administration
Key Trial Info
Start Date :
July 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01143753
Start Date
July 27 2010
End Date
May 2 2017
Last Update
July 28 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Adelaide Hospital; Oncology
Adelaide, South Australia, Australia, 5000
2
Austin Hospital; Medical Oncology
Heidelberg, Victoria, Australia, 3084
3
Royal Melbourne Hospital; Hematology and Medical Oncology
Parkville, Victoria, Australia, 3052
4
Rigshospitalet, Onkologisk Klinik
København Ø, Denmark, 2100