NCT00100685

Brief Summary

This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

2.9 years

First QC Date

January 4, 2005

Last Update Submit

April 25, 2012

Conditions

Renal Cell CarcinomaMetastases

Keywords

Kidneyrenalcancercarcinomacellmetastaticmetastatic renal cell carcinomaRCC

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with a confirmed tumor response at any time during the study

    Any time during the study

Secondary Outcomes (4)

  • Time to disease progression

    Up to 104 weeks

  • Duration of tumor response

    Up to 104 weeks

  • Pharmacokinetics (PK) of M200

    Day 0 through Study Termination

  • Immunogenicity

    Day 0 through Study Termination

Study Arms (2)

Arm 1

EXPERIMENTAL

Volociximab administered intravenously at a dose of 10 mg/kg qowk

Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)

Arm 2

EXPERIMENTAL

Volociximab administered intravenously at a dose of 15 mg/kg qwk

Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)

Interventions

Volociximab (anti-α5β1 integrin monoclonal antibody)DRUG

Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first.

Arm 1Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females of at least 18 years of age with metastatic RCC of predominantly clear cell histology who have received 0 to 2 prior treatment regimens for metastatic disease.
  • Measurable disease according to Response Criteria for Solid Tumors.
  • Negative pregnancy test (women of childbearing potential only).
  • Pretreatment laboratory levels that meet specific criteria.
  • Signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations
  • Patients must have failed at least one approved or investigational tyrosine kinase inhibitor (TKI).

You may not qualify if:

  • Any of the following histologies of RCC: papillary, chromophobe, collecting duct, or unclassified.
  • Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
  • Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
  • Systemic chemotherapy, immunotherapy, radiation therapy, or monoclonal antibody therapy within 4 weeks of M200 administration.
  • Documented central nervous system (CNS) tumor or CNS metastasis.
  • History of thromboembolic events and bleeding disorders within the past year.
  • Medical conditions that may be exacerbated by bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site Reference ID/Investigator# 70400

Los Angeles, California, 90095, United States

Location

Site Reference ID/Investigator# 70401

New York, New York, 10021, United States

Location

Site Reference ID/Investigator# 70399

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasm MetastasisNeoplasmsCarcinoma

Interventions

volociximab

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mihail Obrocea, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2005

First Posted

January 5, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(3)