Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| palifosfamide-tris | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PaCE
- description
- Palifosfamide, Carboplatin and Etoposide
- interventionNames
- Drug: palifosfamide-tris
Primary outcomes (1)
- measure
- Assess the safety profile
- timeFrame
- 21 Days
- description
- Adverse events, vital signs, physical examination, laboratory data and concomitant medications
Secondary outcomes (2)
- measure
- Determine the maximum tolerated dose
- timeFrame
- Up to 21 days
- description
- Each dose level cohort will be 3 subjects. After 3 subjects have received a regimen, there will be a minimum observation period of 1 full cycle (21 days) for each of the 3 subjects before enrollment of the group of subjects at the next dose level.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available