A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Biological: rBBX-01

• Registration Number: NCT00869388
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-12
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Confirmed metastatic or unresectable, resistant solid tumor. Gynecologic tumors preferred.
• 18 years and above
• GOG performance status greater than or equal to 2
• Life expectancy greater than 6 months
• Acceptable organ and marrow function
• Willingness to agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria

• Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Not receiving any other investigational agents
• Known brain metastasis
• Uncontrolled intercurrent illness including, but not limited to ongoing ore active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnancy
• Immunosuppression including subjects with known HIV infection on immunosuppressive drugs or having an autoimmune disorder
• Penicillin allergy
• Symptomatic prostate hypertrophy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	rBBX-01	rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
Arm 2	rBBX-01	rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
Arm 3	rBBX-01	rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
Arm 4 (optional)	rBBX-01	rBBX-01 8.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7

Primary Outcome Measures

Name	Time	Method
To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies.	Four bi-weekly 5 day courses

Secondary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetic and pharmacodynamics of bi-weekly rBBX-01. To correlate the inter-patient sensitivity to rBBX-01 with in vitro studies on patient blood. To describe any anti-tumor activity of rBBX-01.	4 bi-weekly 5 day courses

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States