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

Phase 1
18 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

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

Inclusion Criteria:

- Confirmed metastatic or unresectable, resistant solid tumor. Gynecologic tumors

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies.

Outcome Time Frame:

Four bi-weekly 5 day courses

Safety Issue:


Principal Investigator

Janet Rader, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

December 2009

Related Keywords:

  • Solid Tumors
  • malignant
  • resistant
  • solid tumor
  • Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110