A Phase II Study of AS1411 in Renal Cell Carcinoma

• Sponsor: Antisoma Research (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT00740441
• Collaborator: (none)
• Enrollment: 30
• Locations: 7
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma

Condition or Disease	Intervention/Treatment	Phase
Metastatic Renal Cell Carcinoma	Drug: AS1411	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma
• Study Start Date: Aug 1, 2008
• Anticipated Primary Completion Date: Sep 1, 2009
• Anticipated Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A AS1411 treatment	Drug: AS1411; AS1411 40 mg/kg/day) will be administered on days 1-4 via a continuous iv infusion every 28-day cycle for up to 2 cycles

Outcome Measures

Primary Outcome Measures

1. To determine the Overall Response Rate to AS1411 []

Secondary Outcome Measures

1. To measure progression free survival with AS1411 []

2. To measure time to disease progression with AS1411 []

3. To measure the duration of overall response and stable disease with AS1411 []

4. To determine the safety and tolerability of two cycles of AS1411 []

5. To assess the pharmacokinetic profile of AS1411 []

6. To assess pharmacodynamic markers of AS1411 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically confirmed renal cell carcinoma containing predominant clear cell histology

• Failed or intolerant to 1 or more previous lines of treatments (which must include a Tyrosine Kinase Inhibitor)

Exclusion Criteria:

• Collecting duct histology

• A history of bleeding disorders or currently taking oral vitamin K antagonise medication

• Unstable brain metastases

• History of prior or concomitant malignancy (except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	University of California, Davis Cancer Center	Sacramento	California	United States	95817
3	University of California San Francisco	San Francisco	California	United States	94143
4	St Francis Hospital	Beech Grove	Indiana	United States	46107
5	James Graham Brown Cancer Center, University of Louisville	Louisville	Kentucky	United States	40202
6	Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
7	Medical University of South Carolina	Charleston	South Carolina	United States	29403

Sponsors and Collaborators

• Antisoma Research

Investigators

• Principal Investigator: Greg Smith, MD, Saint Francis Memorial Hospital
• Principal Investigator: Harry Drabkin, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00740441
• Other Study ID Numbers: AS1411-C-202
• First Posted: Aug 25, 2008
• Last Update Posted: Sep 25, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: renal cell carcinoma; rcc; kidney cancer
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell

Study Results

No Results Posted as of Sep 25, 2009