A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00532090
First received: September 18, 2007
Last updated: April 1, 2014
Last verified: April 2014
  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 1

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:


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: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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
Experimental: 2 Drug: RG4733
Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle
Experimental: 3 Drug: RG4733
Administered orally daily at ascending doses to successive cohorts of patients

  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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00532090     History of Changes
Other Study ID Numbers: NO21321
Study First Received: September 18, 2007
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 20, 2014