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

July 12, 2013 updated by: Washington University School of Medicine
This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Four bi-weekly 5 day courses

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 bi-weekly 5 day courses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Premal Thaker, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 12, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0961

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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