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NCT Number: NCT01143753

A Study of RO5212054 (PLX3603) in Participants With BRAF V600-Mutated Advanced Solid Tumors

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Adelaide Hospital; Oncology, Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5212054

Drug

Participants will receive RO5212054 at a starting dose of 200 milligrams (mg) orally once daily in each 21 day cycle. Dose levels for escalation will be decided based on the safety assessment of previous cohort. Dose escalations in increments of 50-100 percent are planned.

Other names: PLX3603

Primary outcomes

  1. Percentage of Participants With Dose Limiting Toxicity

    Time frame: Baseline up to 21 days

  2. Maximal Tolerated Dose of RO5212054

    Time frame: Baseline up to 21 days

  3. Maximum Plasma Concentration of RO5212054

    Time frame: Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)

    Detailed timeframe:

    Pre-dose (0 hour [hr]): Day 1 of Cycles 1-10; Days 4, 8, 15 of Cycle 1. Post-dose: 1, 2, 4, 8, 12, 24 hr on Day 1 Cycle 1; Between 2-4 hr (1 sample) on Day 8 Cycle 1 and Day 1 Cycles 2-9; 1, 2, 4, 8, Between 10-12 hr (1 sample), 24 hr on Day 15 Cycle 1 (cycle length: 21 days)

  4. Time to Reach Maximum Plasma Concentration of RO5212054

    Time frame: Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)

    Detailed timeframe:

    Pre-dose (0 hr): Day 1 of Cycles 1-10; Days 4, 8, 15 of Cycle 1. Post-dose: 1, 2, 4, 8, 12, 24 hr on Day 1 Cycle 1; Between 2-4 hr (1 sample) on Day 8 Cycle 1 and Day 1 Cycles 2-9; 1, 2, 4, 8, Between 10-12 hr (1 sample), 24 hr on Day 15 Cycle 1 (cycle length: 21 days)

  5. Area Under The Plasma Concentration-Time Curve of RO5212054

    Time frame: Baseline up to cycle 10 (cycle length: 21 days) (detailed timeframe is given in description)

    Detailed timeframe:

    Pre-dose (0 hr): Day 1 of Cycles 1-10; Days 4, 8, 15 of Cycle 1. Post-dose: 1, 2, 4, 8, 12, 24 hr on Day 1 Cycle 1; Between 2-4 hr (1 sample) on Day 8 Cycle 1 and Day 1 Cycles 2-9; 1, 2, 4, 8, Between 10-12 hr (1 sample), 24 hr on Day 15 Cycle 1 (cycle length: 21 days)

Secondary outcomes

  1. Percentage of Participants With Adverse Events

    Time frame: Baseline up to approximately 7 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2017
First posted
Jun 14, 2010
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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