Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice
1 other identifier
interventional
12
1 country
4
Brief Summary
This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.
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 Nov 2010
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 12, 2010
CompletedFirst Posted
Study publicly available on registry
November 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 18, 2012
July 1, 2012
2.1 years
November 12, 2010
July 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the safety profile
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
21 Days
Secondary Outcomes (2)
Determine the maximum tolerated dose
Up to 21 days
Assess early signs of efficacy
duration of study
Study Arms (1)
PaCE
EXPERIMENTALPalifosfamide, Carboplatin and Etoposide
Interventions
Eligibility Criteria
You may qualify if:
- years old or greater
- Malignancy scheduled to receive etoposide and carboplatin therapy
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
- Adequate bone marrow, liver, renal function and coagulation status
- Informed consent
- Agree to use birth control through 28 days of last treatment dose
- Pregnancy test for women of child-bearing potential
- No available standard therapy
You may not qualify if:
- Allergy to the the study treatment drugs
- Unstable current medical condition
- Presence or history of injury to the urinary tract
- Active infection
- Major surgery within 4 weeks prior to treatment
- Minor surgery within 2 weeks prior to treatment
- Current acute steroid therapy or taper
- Currently pregnant or nursing
- Substance abuse or condition that may interfere with participation
- Received other investigational drugs within 30 days
- Within 4 weeks of their last chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Horizon Oncology Research
Lafayette, Indiana, 47905, United States
Medical Consultants, PC
Muncie, Indiana, 47303, United States
Washington University
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2010
First Posted
November 16, 2010
Study Start
November 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 18, 2012
Record last verified: 2012-07