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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073125
• Other study ID #: M02-428
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2003
• Last updated: August 13, 2007
• Start date: May 2003

Study information

• Verified date: August 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00080704

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• ABT-510/Thrombospondin-1 mimetic

Locations

Country	Name	City	State
Netherlands	Academic Hospital Groningen	Groningen
United States	Albany Regional Cancer Center	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	The Center for Hematology-Oncology	Boca Raton	Florida
United States	Raleigh Hematology Oncology Clinic	Cary	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	US Oncology, P.A.	Dallas	Texas
United States	Texas Cancer Center	Fort Worth	Texas
United States	Texas Cancer Center	Fort Worth	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Central indiana Cancer Center	Indianapolis	Indiana
United States	Kansas City Oncology and Hematology Group	Kansas City	Missouri
United States	UCLA School of Medicine	Los Angeles	California
United States	Clinical Trials and Research Associates	Montebello	California
United States	Kansas City Cancer Centers Southwest	Overland Park	Kansas
United States	Virginia G. Piper Cancer Center	Scottsdale	Arizona
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		One year
Secondary	Response rate		One year
Secondary	Overall survival		One year
Secondary	Performance status		One year