A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00532090
First received: September 18, 2007
Last updated: June 11, 2013
Last verified: June 2013
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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 |
| Estimated Study Completion Date: | February 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, 02215 | |
| Boston, Massachusetts, United States, 02114 | |
| Boston, Massachusetts, United States, 02115 | |
| 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: | June 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 13, 2013