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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
Open (Enrolling)
Both
Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma, Ovarian Cancer, Osteosarcoma

Thank you

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