This trial is active, not recruiting.

Condition colorectal cancer, malignant melanoma, neoplasms
Treatment ro5212054
Phase phase 1
Sponsor Hoffmann-La Roche
Start date July 2010
End date September 2016
Trial size 45 participants
Trial identifier NCT01143753, 2010-018330-42, NP25247


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
cohorts receiving escalating doses orally

Primary Outcomes

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
Pharmacokinetics: Cmax, Tmax, AUC, elimination
time frame: from baseline to 28 days after last dose of stdy drug

Secondary Outcomes

Overall safety profile: Adverse events, ECG, vital signs, dermatological evaluation, haematology, serum chemistry, urinalysis
time frame: through to end of study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.