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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Early Recognition Center
  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 September 30, 2014