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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00869388
First received: March 25, 2009
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Solid Tumors
Biological: rBBX-01
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies. [ Time Frame: Four bi-weekly 5 day courses ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 4 bi-weekly 5 day courses ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
Biological: rBBX-01
Experimental: Arm 2
rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
Biological: rBBX-01
Experimental: Arm 3
rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
Biological: rBBX-01
Experimental: Arm 4 (optional)
rBBX-01 8.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
Biological: rBBX-01

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869388

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Premal Thaker, M.D. Washington University
  More Information

Additional Information:
Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00869388     History of Changes
Other Study ID Numbers: 08-0961
Study First Received: March 25, 2009
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
malignant
resistant
solid tumor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014