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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01143753
First received: June 11, 2010
Last updated: August 4, 2014
Last verified: August 2014

June 11, 2010
August 4, 2014
July 2010
October 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01143753 on ClinicalTrials.gov Archive Site
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 ]
  • 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 ]
  • Dose-escalating phase: Preliminary evidence of anti-tumour activity according to RECIST criteria, tumour assessments by CT/MRI [ Time Frame: from baseline to disease progression ] [ Designated as safety issue: No ]
  • Pharmacodynamic impact on mitogen activated protein kinase (MAPK) inhibition, assessed by tumour biopsy [ Time Frame: from baseline to disease progression ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of RO5212054 (PLX3603) in Patients With BRAF V600-mutated Advanced Solid Tumours
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

This open-label, multi-center study will evaluate the safety, tolerability, and pharmacokinetics of RO5212054 [PLX3603] in patients with BRAF V600-mutated advan ced solid tumours. Cohorts of patients will receive escalating oral doses of RO5 212054. Anticipated time on study treatment is until disease progression or unac ceptable toxicity occurs.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer, Malignant Melanoma, Neoplasms
Drug: RO5212054
cohorts receiving escalating doses orally
Experimental: Single group
Intervention: Drug: RO5212054
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Denmark,   Spain
 
NCT01143753
NP25247, 2010-018330-42
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP