A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00532090

Purpose

This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.

Condition	Intervention	Phase
Neoplasms	Drug: RG4733	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:	Multiple Ascending Dose (MAD) Study of R4733 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid 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:

AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor assessments [ Time Frame: day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter ] [ Designated as safety issue: No ]
Pharmacokinetic profile [ Time Frame: After first dose and last dose (or day 15) of cycles 1 and 2 ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	November 2007
Study Completion Date:	January 2011

Arms	Assigned Interventions
Experimental: 1	Drug: RG4733 Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule Other Name: RO4929097
Experimental: 2	Drug: RG4733 Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle Other Name: RO4929097
Experimental: 3	Drug: RG4733 Administered orally daily at ascending doses to successive cohorts of patients Other Name: RO4929097

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 solid tumor malignancy;
measurable or evaluable disease;
ECOG performance status 0 or 1.

Exclusion Criteria:

prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug. Dexamethasone may be allowed only as part of the supportive care measures;
major surgery within 28 days of first receipt of study drug.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532090

Locations

United States, Colorado

Aurora, Colorado, United States, 80045
United States, Massachusetts

Boston, Massachusetts, United States, 02115

Boston, Massachusetts, United States, 02114

Boston, Massachusetts, United States, 02215
United States, New Jersey

New Brunswick, New Jersey, United States, 08901
United States, Texas

Houston, Texas, United States, 77030

San Antonio, Texas, United States, 98229

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:	NCT00532090 History of Changes
Other Study ID Numbers:	NO21321
Study First Received:	September 18, 2007
Last Updated:	October 14, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012