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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the safety profile of MDX 1411

Outcome Time Frame:

duration of study

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

MDX1411-01

NCT ID:

NCT00656734

Start Date:

April 2008

Completion Date:

June 2010

Related Keywords:

  • Kidney Cancer
  • Medarex Inc.
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Montefiore Medical CenterBronx, New York  10467-2490
Providence Portland Medical CenterPortland, Oregon  97213-3635
Nevada Cancer InstituteLas Vegas, Nevada  89135
Beth Israel Deaconness Medical CenterBoston, Massachusetts  02215