A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00817518

Enrollment

145

Registered

2009-01-06

Start date

2009-01-31

Completion date

2014-12-31

Last updated

2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Brief summary

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.

Interventions

DRUGRO4987655

Administered po daily for 28 days, at escalating doses, with a starting dose of 1mg (Part 1) maximum tolerated dose administered po daily until disease progression(Part 2)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (Part 1)	Reviewed after each 4 week cycle
Tumor assessments (Part 2)	Every 8 weeks

Secondary

Measure	Time frame
Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2)	Reviewed after each 4 week cycle

Countries

France, Germany, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026