Completed

An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors

What is being tested

RO4987655

Drug

Who is being recruted

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: January 2009

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: January 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily 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 metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Official TitleAn Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors

NCT00817518

Principal SponsorHoffmann-La Roche

Last updated: January 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

145 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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 or other responsive tumor type (Part 2); * measurable and/or evaluable disease (Part 1); \>=1 measurable lesion (Part 2); * ECOG performance status 0-2. 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; * active CNS lesions; * acute or chronic infection.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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CompletedNo study centers