Clinical trial NCT01143753: A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, multi-center study will evaluate the safety, tolerability, and pharmacokinetics of RO5212054 \[PLX3603\] in participants with BRAF V600-mutated advanced solid tumors. Cohorts of participants will receive escalating oral doses of RO5212054. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumor
* Dose-escalation phase: Histologically confirmed, newly diagnosed or relapsed/ refractory unresectable American Joint Committee on Cancer (AJCC) Stage IIIC or IV disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate liver, renal and bone marrow function

Exclusion Criteria:

* Participants for whom standard therapy exists and is considered appropriate by the investigator
* Prior treatment with an inhibitor of BRAF (sorafenib allowed)
* Active Central nervous system (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

Primary outcomes:
measure: Percentage of Participants With Dose Limiting Toxicity
timeFrame: Baseline up to 21 days
measure: Maximal Tolerated Dose of RO5212054
timeFrame: Baseline up to 21 days
measure: Maximum Plasma Concentration of RO5212054
timeFrame: Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)
measure: Time to Reach Maximum Plasma Concentration of RO5212054
timeFrame: Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)
measure: Area Under The Plasma Concentration-Time Curve of RO5212054
timeFrame: Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)
Secondary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to approximately 7 years
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital; Oncology
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Hospital; Medical Oncology
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital; Hematology and Medical Oncology
state: Victoria
city: København Ø
country: Denmark
facility: Rigshospitalet, Onkologisk Klinik
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dienstmann R, Lassen U, Cebon J, Desai J, Brown MP, Evers S, Su F, Zhang W, Boisserie F, Lestini B, Schostack K, Meresse V, Tabernero J. First-in-Man Dose-Escalation Study of the Selective BRAF Inhibitor RG7256 in Patients with BRAF V600-Mutated Advanced Solid Tumors. Target Oncol. 2016 Apr;11(2):149-56. doi: 10.1007/s11523-015-0381-x.