Clinical trial · Interventional
A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
A Phase I Study to Determine the Dose of the Combination of Yondelis and Doxorubicin for Which Neutropenia is Manageable With the Support of Granulocyte-Colony Stimulation Factor in Subjects With Recurrent or Persistent Soft Tissue Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Histologic Type | — | UNRESOLVED | — |
| Neoplasms, Connective and Soft Tissue | Connective and Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Trabectedin | Drug | Trabectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trabectedin and doxorubicin
- description
- Doxorubicin (50 to 75 mg/m2) administered intravenously on Day 1 followed by trabectedin (0.9 to 1.3 mg/m2) administered intravenously on Day 1 every 3 weeks for up to 6 cycles. Dexamethasone 20 mg administered intravenously will be given within 1 hour before the start of doxorubicin. Patients may receive filgrastim for unmanageable neutropenia.
- interventionNames
- Drug: Doxorubicin
- Drug: Trabectedin
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Number of patients with adverse events as a measure of safety
- timeFrame
- Up to approximately 19 weeks (six 3-week treatment cycles+30 day safety follow up)
Secondary outcomes (5)
- measure
- The number of patients with clinically relevant changes in clinically laboratory tests
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a diagnosis of soft tissue sarcoma, recurrent or persistent * Signed informed consent obtained for all patients before performing any study-related procedures Exclusion Criteria: * Patients treated with more than 1 prior chemotherapy regimen (including adjuvant (or other additional) therapy) * Previous exposure to anthracyclines (a class of drugs used in cancer chemotherapy, example is Doxorubicin) or trabectedin * Less than 4 weeks since radiation therapy * Known metastases (spread) of cancer to the central nervous system * Other ongoing serious illness present at the time of enrollment as determined by the Investigator
References
Publications (0)
Data not yet available