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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00817518

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: RO4987655	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Maximum tolerated dose (Part 1) [ Time Frame: Reviewed after each 4 week cycle ] [ Designated as safety issue: No ]
Tumor assessments (Part 2) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2) [ Time Frame: Reviewed after each 4 week cycle ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2013

Arms	Assigned Interventions
Experimental: 1	Drug: RO4987655 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)
Experimental: 2	Drug: RO4987655 Administered po daily for 28 days, at escalating doses , with a starting dose of 1mg (Part 1). Optimal biological dose administered po daily until disease progression (Part 2)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817518

Contacts

Contact: Please reference Study ID Number: BO21189

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

France
	Active, not recruiting
Marseille, France, 13385
	Active, not recruiting
Paris, France, 75231
	Recruiting
Paris, France, 75651
	Active, not recruiting
Villejuif, France, 94805
Germany
	Completed
Essen, Germany, 45147
Netherlands
	Active, not recruiting
Amsterdam, Netherlands, 1066 CX
Spain
	Active, not recruiting
Barcelona, Spain, 08003
	Active, not recruiting
Madrid, Spain, 28050
	Recruiting
Sevilla, Spain, 41013
United Kingdom
	Recruiting
Cambridge, United Kingdom, CB2 2QQ
	Recruiting
London, United Kingdom, SW3 6JJ
	Active, not recruiting
Oxford, United Kingdom, OX3 7LJ

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00817518 History of Changes
Other Study ID Numbers:	BO21189, 2007-002021-77
Study First Received:	December 16, 2008
Last Updated:	January 17, 2012
Health Authority:	Netherlands: Medicines Evaluation Board

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012