A Study of RO5212054 (PLX3603) in Patients With BRAF V600-mutated Advanced Solid Tumours
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01143753
First received: June 11, 2010
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
This open-label, multi-center study will evaluate the safety, tolerability, pharmacokinetics and efficacy 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 |
|---|---|---|
|
Malignant Melanoma, Neoplasms, Colorectal Cancer |
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 ]
- Extension cohort: Tumour response according to RECIST criteria (best overall response rate, duration of response, progression-free survival) assessed by CT or MRI [ Time Frame: from baseline to disease progression ] [ 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 ]
- 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 ]
| Enrollment: | 45 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single group |
Drug: RO5212054
cohorts receiving escalating doses orally
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
- for melanoma patients in the extension phase: prior systemic therapy for advanced disease (prior adjuvant immunotherapy allowed)
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143753
Locations
| Australia, South Australia | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Heidelberg, Victoria, Australia, 3084 | |
| Parkville, Victoria, Australia, 3052 | |
| Denmark | |
| Copenhagen, Denmark, 2100 | |
| Spain | |
| Barcelona, Spain, 08035 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| 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: | May 23, 2013 |
| Health Authority: | Spain: Ministry of Health |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Melanoma Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 23, 2013