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

The Washington University logo

The Washington University

Status and phase

Completed
Phase 1

Conditions

Solid Tumors

Treatments

Biological: rBBX-01

Study type

Interventional

Funder types

Other

Identifiers

NCT00869388
08-0961

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 4 patient groups

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems