Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer. (MDX1411-01)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00656734
First received: April 3, 2008
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: MDX 1411 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Open-Label, Multicenter Dose-escalation, Multidose Study of MDX1411 Administered Every 14 Days in Subjects With Advanced or Recurrent Clear Cell Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Determine the safety profile of MDX 1411 [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
- Determine the maximum tolerated dose of MDX 1411 [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Determine the best overall response rate (BORR) [ Time Frame: Day 38-42 of each cycle ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | April 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MDX 1411
Dose Escalation Cohorts
|
Biological: MDX 1411
MDX-1411 (fully human monoclonal antibody) administered as an i.v. infusion for up to 5 doses per cycle, with a maximum of 17 cycles total
|
Detailed Description:
Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of RCC with clear cell component
- Measurable disease
- Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy
- Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible
- At least 28 days since the last chemotherapy
- At least 28 days before the first dose of MDX 1411 since any major surgery
- ECOG performance status 0-2
- No known positivity for human immunodeficiency virus (HIV), Hep B or C
Exclusion Criteria:
- Previous treatment with any other anti-CD70 antibody
- Active infection requiring i.v systemic therapy within 28 days before first dose
- Evidence of bleeding diathesis or coagulopathy
- Active autoimmune disease requiring immunosuppressive therapy
- Known current drug or alcohol abuse
- Any underlying medical condition which will make the administration of MDX 1411 hazardous
- Psychiatric illness or social situation that would preclude study compliance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656734
Locations
| United States, Massachusetts | |
| Beth Israel Deaconness Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10466 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00656734 History of Changes |
| Other Study ID Numbers: | MDX1411-01, CA214-001 |
| Study First Received: | April 3, 2008 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Medarex Inc. |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013