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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma, Neoplasms, Colorectal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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)

Outcome Time Frame:

from baseline to 28 days after last dose of study drug

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Ministry of Health

Study ID:

NP25247

NCT ID:

NCT01143753

Start Date:

July 2010

Completion Date:

October 2014

Related Keywords:

  • Malignant Melanoma, Neoplasms, Colorectal Cancer
  • Neoplasms
  • Colorectal Neoplasms
  • Melanoma

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