Trials Sponsors Conditions Drugs Pricing

Conditions

Metastases Renal Cell Carcinoma

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Sponsors & Collaborators

Abbott
Industrylead

Study Sites (3)

Site Reference ID/Investigator# 70400

Los Angeles, California, 90095, United States

Site Reference ID/Investigator# 70401

New York, New York, 10021, United States

Site Reference ID/Investigator# 70399

Cleveland, Ohio, 44195, United States

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 Complications

Study Officials

Mihail Obrocea, MD
Abbott
STUDY DIRECTOR

Enrollment

48 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations