Study Stopped
Lack of enrollment
Study of Opebacan in Patients Undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
HSCT
A Phase I/II Study of the Safety and Pharmacokinetics of Opebacan (rBPI21) in Patients Undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
1 other identifier
interventional
6
1 country
1
Brief Summary
The objectives of this study are as follows: To demonstrate the safety of escalating doses of opebacan in subjects undergoing myeloablative allogeneic Hematopoietic Stem Cell Transplantation To determine the pharmacokinetics of opebacan in subjects undergoing myeloablative allogeneic Hematopoietic Stem Cell Transplantation To determine if IV administration of opebacan is associated with changes in biological markers for inflammation To develop preliminary descriptive data on the occurrence and severity of Hematopoietic Stem Cell Transplantation related complications, including aGvHD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2007
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 30, 2012
May 1, 2011
3.3 years
March 28, 2007
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Time to engraftment
100 days
Inflammatory markers
100 days
Inflammatory states
100 days
Transplant-related complications
100 days
The pharmacokinetics of opebacan
100 days
Study Arms (1)
Opebacan
EXPERIMENTALInterventions
4 mg/kg continuous IV infusion for 30 minutes followed immediately by 6 mg/kg/day continuous IV infusion for 3 days
Eligibility Criteria
You may qualify if:
- Age \<= 60 and undergoing allogeneic HSCT
- Life expectancy \> 8 weeks
- Scheduled for treatment with a conditioning regimen intended to be myeloablative
- Female subjects of child-bearing age must have a negative urine pregnancy test. Sexually active male and female subjects of reproductive age must be using a form of contraception considered effective and medically acceptable by the Investigator.
You may not qualify if:
- Cumulative lifetime exposure of \> 300 mg/M2 of anthracycline (expressed as doxorubicin equivalent dose) or receipt of anthracycline within 180 days prior to initiating conditioning for HSCT
- Active infection
- Prophylactic antibacterial antibiotics.
- Positive for HIV, HTLV-I, or HTLV-II
- Any prior stem cell transplant
- Prior history of CHF
- Cord blood is the source of a subject's transplanted cells.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XOMA (US) LLClead
Study Sites (1)
Unknown Facility
Boston, Massachusetts, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva C Guinan, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2007
First Posted
March 30, 2007
Study Start
February 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
July 30, 2012
Record last verified: 2011-05