A Study of RO5212054 (PLX3603) in Patients With BRAF V600-mutated Advanced Solid Tumours

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: June 11, 2010
Last updated: February 1, 2016
Last verified: February 2016
This open-label, multi-center study will evaluate the safety, tolerability, and pharmacokinetics of RO5212054 [PLX3603] in patients with BRAF V600-mutated advanced solid tumours. Cohorts of patients will receive escalating oral doses of RO5212054. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Condition Intervention Phase
Colorectal Cancer, Malignant Melanoma, Neoplasms
Drug: RO5212054
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multiple Ascending Dose (MAD) Study of the Selective BRAF Inhibitor RO5212054 (PLX3603) to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With BRAF V600-mutated Advanced Solid Tumours

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Dose-escalation phase: Safety and tolerability, dose-limiting toxicities, maximum tolerated dose (adverse events, ECG, vital signs, dermatological evaluation, haematology, serum chemistry, urinalysis) [ Time Frame: from baseline to 28 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Cmax, Tmax, AUC, elimination [ Time Frame: from baseline to 28 days after last dose of stdy drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall safety profile: Adverse events, ECG, vital signs, dermatological evaluation, haematology, serum chemistry, urinalysis [ Time Frame: through to end of study ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: July 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single group Drug: RO5212054
cohorts receiving escalating doses orally


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • advanced solid tumour
  • dose-escalation phase: either relapsed/refractory disease after prior therapy or melanoma patients with newly diagnosed (treatment-naïve) unresectable AJCC stage IIIC or stage IV disease are eligible
  • melanoma extension phase: newly diagnosed unresectable AJCC stage IIIC or IV disease
  • colorectal cancer extension phase: relapsed/refractory metastatic disease
  • confirmed BRAF V600 mutation status; for extension phases confirmation by Cobas test required
  • ECOG performance status 0-1
  • adequate liver, renal and bone marrow function

Exclusion Criteria:

  • patients for whom standard therapy exists and is considered appropriate by the investigator
  • prior treatment with an inhibitor of BRAF (sorafenib allowed)
  • active 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143753

Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
Parkville, Victoria, Australia, 3052
København, Denmark, 2100
Barcelona, Spain, 08035
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01143753     History of Changes
Other Study ID Numbers: NP25247  2010-018330-42 
Study First Received: June 11, 2010
Last Updated: February 1, 2016
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on February 07, 2016