Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00073125

Collaborator

(none)

103

Enrollment

Locations

5.7

Patients Per Site

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess the safety and efficacy of ABT-510 in subjects with advanced renal cell carcinoma.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: ABT-510/Thrombospondin-1 mimetic	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma

Study Start Date :

May 1, 2003

Outcome Measures

Primary Outcome Measures

Progression free survival [One year]

Secondary Outcome Measures

Response rate [One year]
Overall survival [One year]
Performance status [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A subject will be eligible for study participation if all of the following criteria are met:

The subject is at least 18 years of age.
The subject has advanced histologically documented renal cell carcinoma. Advanced disease is defined as locally recurrent disease or metastatic disease that is not amendable to curative resection.
The subject has not received prior therapy (anti-tumor radiotherapy, immunotherapy, chemotherapy, or investigational therapy) for metastatic renal cell carcinoma other than excision of primary tumor where appropriate. Local radiation for supportive reasons will be allowed; however, not within 28 days from Study Day 1.
The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1
The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
The subject must have adequate bone marrow, renal, and hepatic function as follows:
Bone Marrow: White blood cell count (WBC) ≥ 3,000/mm3 (3.0 X 109/L); Platelets ≥ 100,000/mm3 (100 X 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L)
Renal function: serum creatinine ≤ 2.0 mg/dL (0.81 mmol/L)
Hepatic function: AST and ALT ≤ 1.5 X ULN unless liver metastases are present, then AST and ALT ≤ 5.0 X ULN; LDH ≤ 1.5 X ULN; bilirubin ≤ 1.5 mg/dL (0.026 mmol/L) Corrected calculated calcium ≤ 10 mg/dL (2.5 mmol/L) Calculation = total calcium - 0.707 (albumin -3.4)Albumin ≥ 3.0 g/dL (0.45 mmol/L)
The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.
The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Exclusion Criteria:

A subject will be ineligible for study participation if any of the following criteria are met:

The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.
The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose Coumadin) for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding.
The subject exhibits evidence of clinically significant uncontrolled conditions(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
The subject has history of other previous malignancies within 5 years, with the exception of: Adequately treated in situ carcinoma of the cervix uteri or Basal or squamous cell carcinoma of the skin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia G. Piper Cancer Center	Scottsdale	Arizona	United States	85258
2	Arizona Cancer Center	Tucson	Arizona	United States	85724
3	UCLA School of Medicine	Los Angeles	California	United States	90024
4	Clinical Trials and Research Associates	Montebello	California	United States	90640
5	The Center for Hematology-Oncology	Boca Raton	Florida	United States	33486
6	University of Chicago Medical Center	Chicago	Illinois	United States	60637
7	Central indiana Cancer Center	Indianapolis	Indiana	United States	46227
8	Kansas City Cancer Centers Southwest	Overland Park	Kansas	United States	66210
9	University of Michigan	Ann Arbor	Michigan	United States	48109
10	Kansas City Oncology and Hematology Group	Kansas City	Missouri	United States	64111
11	Albany Regional Cancer Center	Albany	New York	United States	12208
12	Raleigh Hematology Oncology Clinic	Cary	North Carolina	United States	27511
13	US Oncology, P.A.	Dallas	Texas	United States	75246
14	Texas Cancer Center	Fort Worth	Texas	United States	66210
15	Texas Cancer Center	Fort Worth	Texas	United States	76104
16	MD Anderson Cancer Center	Houston	Texas	United States	77030
17	Baylor College of Medicine	Houston	Texas	United States
18	Academic Hospital Groningen	Groningen		Netherlands

Sponsors and Collaborators

Abbott

Investigators

Study Director: Rod Humerickhouse, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00073125

Other Study ID Numbers:

M02-428
NCT00080704

First Posted:

Nov 18, 2003

Last Update Posted:

Aug 15, 2007

Last Verified:

Aug 1, 2007

Keywords provided by , ,

Advanced histologically documented renal cell carcinoma

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Renal Cell

Study Results

No Results Posted as of Aug 15, 2007