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
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma, Ovarian Cancer, Osteosarcoma
Both
Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma, Ovarian Cancer, Osteosarcoma
Trial Information
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
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assess the safety profile
Outcome Description:
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
Outcome Time Frame:
21 Days
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
IPM1004
NCT ID:
NCT01242072
Start Date:
November 2010
Completion Date:
December 2012
Related Keywords:
- Malignancy
- Cancer
- Non Small Cell Lung Cancer
- Small Cell Lung Cancer
- Testicular Cancer
- Thymoma
- Ovarian Cancer
- Osteosarcoma
- malignancy
- etoposide and carboplatin
- non small cell lung cancer
- small cell lung cancer
- testicular cancer
- thymoma
- ovarian cancer
- osteosarcoma
- Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Osteosarcoma
- Ovarian Neoplasms
- Testicular Neoplasms
- Thymoma
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Washington University | St. Louis, Missouri 63110 |
| Medical Consultants, PC | Muncie, Indiana 47304 |
| Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |
| Horizon Oncology Research | Lafayette, Indiana 47905 |
