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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00773526

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: RO5126766	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Maximum tolerated dose (Part 1) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Tumor assessments (Part 2) [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2). [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Estimated Study Completion Date:	January 2011

Arms	Assigned Interventions
1: Experimental	Drug: RO5126766 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).

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, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773526

Contacts

Contact: Please reference Study ID Number: NO21895	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

France
	Not yet recruiting
VILLEJUIF, France, 94805
Spain
	Recruiting
BARCELONA, Spain, 08003
United Kingdom
	Not yet recruiting
SUTTON, United Kingdom, SM2 5PT

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NO21895, 2008-002298-11
Study First Received:	October 15, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00773526
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 14, 2009