Clinical trial · Interventional
A Phase 1 Pilot Study of the Subcutaneous (s.c.) Route to Facilitate the Administration of RRx-001
NCT02096341CI-TRIAL-00020617terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Subcutaneous administration of RRx-001 is no longer of interest.
Summary
Brief summary (as posted)
To investigate the dosage of RRx-001 by the subcutaneous route.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphomas | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RRx-001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RRx-001
- description
- RRx-001 will be administered as subcutaneous injections twice weekly for at least 8 weeks. At least three subjects must complete 2 weeks of treatment with RRx-001 at each dose level, before escalation to the next higher RRx-001 dose level; 2 doses-16 and 27 mg/m2- will be tested.
- interventionNames
- Drug: RRx-001
Primary outcomes (1)
- measure
- Number of Participants with Serious and Non-Serious Adverse Events
- timeFrame
- 10 weeks
Secondary outcomes (2)
- measure
- Area under the plasma concentration versus time curve (AUC) of RRx-001-glutathione conjugate
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years old. * ECOG (performance) status of 0, 1 or 2. * Histologically or cytologically confirmed primary or metastatic advanced solid tumors or lymphoma. Subjects with curative treatment options are not eligible for the protocol. * No active ongoing cancer treatment (except for prostate cancer subjects receiving luteinizing hormone-releasing hormone (LHRH) agonists and anti-androgens such as; Flutamide, Dutasteride, and Finasteride). * Adequate organ and bone marrow function. * Male and female subjects of childbearing potential must agree to use contraception. Exclusion Criteria: * Pregnant or breast-feeding. * Use of anti-coagulant therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.