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OpenTrials
Completed

NCT Number: NCT00773526

A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.

This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

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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

Villejuif, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients, >=18 years of age;
  • advanced and/or metastatic cancer not amenable to standard therapy;
  • any solid tumor type (Part 1); malignant melanoma, pancreatic cancer or non-small cell lung cancer (Part 2);
  • measurable and/or evaluable disease (Part 1), >=1 measurable lesion (Part 2);
  • ECOG performance status 0-1.

Exclusion criteria

  • prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
  • prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
  • known past or present CNS metastases;
  • acute or chronic infection.

Treatment and study plan

RO5126766

Drug

Administered orally daily for 28 days, at escalating doses (with a starting dose of 0.1mg) (Part 1). Optimal biological dose or maximum tolerated dose administered orally, daily (Part 2).

Primary outcomes

  1. Maximum tolerated dose (Part 1)

    Time frame: Throughout study

  2. Tumor assessments (Part 2)

    Time frame: Event driven

Secondary outcomes

  1. AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2).

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 16, 2008
Registry last updated
Nov 2, 2016

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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