Clinical trial · Interventional
A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma
A Dose Escalation and Dose Expansion Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma - CEP-2
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
This is a Phase I, open-label, dose-escalation and dose-expansion study of NOX66 given rectally, in cohorts of patients with metastatic soft tissue sarcoma (STS) who have not been exposed to anthracycline therapy, using a fixed dose-escalation schema every 21 days to establish the maximum tolerated dose (MTD) of the combination of NOX66 and doxorubicin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Soft-tissue Sarcoma | Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| NOX66 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose-Escalation Cohort 1: NOX66 800 mg + Doxorubicin
- interventionNames
- Drug: NOX66
- Drug: Doxorubicin
- type
- EXPERIMENTAL
- label
- Dose-Escalation Cohort 2: NOX66 1200 mg + Doxorubicin
- interventionNames
- Drug: NOX66
- Drug: Doxorubicin
- type
- EXPERIMENTAL
- label
- Dose-Escalation Cohort 3: NOX66 1800 mg + Doxorubicin
- interventionNames
- Drug: NOX66
- Drug: Doxorubicin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with a histologically confirmed diagnosis of metastatic or recurrent soft tissue sarcoma * Patients for whom treatment with doxorubicin is considered to be appropriate * Left ventricular ejection fraction ≥ 50% * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Disease that is considered measurable according to RECIST v1.1. Exclusion Criteria: * Histologically or cytologically confirmed Kaposi's sarcoma, gastrointestinal stromal tumor (GIST), extra-skeletal myxoid chondrosarcoma, epithelioid hemangioendothelioma, and desmoid tumor * Untreated metastases to the central nervous system * Received previous treatment with anthracyclines and anthracenediones * Previous radiation therapy to the mediastinal or pericardial area * A known allergy to any of the treatment components * Patient not willing to use suppositories * Patients with a colostomy * Patients who have had a colectomy (total or left hemicolectomy) with re-anastomosis * Patients for whom administration of the suppositories are likely to cause pain (e.g., inflamed hemorrhoids, fissures, or lesions of the anus or rectum) * Patients with fecal impaction, chronic idiopathic constipation, or chronic diarrhea or alternating irritable bowel disease * Patients with inflammatory bowel disease * Previous treatment with an investigational agent or the non-approved use of a drug or device within 4 weeks before study entry * Uncontrolled diabetes mellitus * Patients who require concomitant use of strong inhibitors or inducers of CYP3A4, CYP2D6 or P- glycoprotein (P- gp)
References
Publications (0)
Data not yet available