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NCT02871843 · ClinicalTrials.gov registry record · Phase 1
RRx-001 + Radiation + Temozolomide In Newly Diagnosed Glioblastoma and Anaplastic Gliomas
A Phase 1 study, sponsored by EpicentRx.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT02871843 is a Phase 1 study that has completed, run by EpicentRx. The registered enrollment target is 19 participants.
The verdict
NCT02871843, a Phase 1 study, has completed, sponsored by EpicentRx.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By "add-on" what is meant is that the experimental intravenous therapy, RRx-001, is combined or "added on" to standard of care. In newly diagnosed GBM standard of care consists of radiotherapy + temozolomide (TMZ) for 6 weeks followed (after a 4-6 weeks break) by maintenance TMZ given until the tumor progresses or worsens. By "maintenance" therapy what is meant is that TMZ is given less frequently to prolong or extend the time during which the tumor remains stable. G-FORCE-1 will be conducted in two parts; in the first part of the study (Dose Escalation, Part A) patients will be entered or assigned sequentially (that is consecutively) to gradually escalating or increasing doses of RRx-001 after patients have been entered on the previous dose until such time as it is no longer tolerated. At each dose level, a separate cohort or small group of at least 3 evaluable patients will be treated. RRx-001 will be administered by intravenous infusion (in other words, by slow injection in the veins) over 30-45 minutes once weekly during radiotherapy for 6 weeks followed by the FDA-approved chemotherapy, temozolomide (TMZ) alone for up to 6 months or longer. In the second part of this study (Part B), new groups or cohorts of patients will receive RRx-001 at the dose established in Part A by intravenous infusion over 30-45 minutes once weekly during radiotherapy for 6 weeks. Then, after a 4-6 weeks break, each cohort will receive increasing doses of RRx-001 and temozolomide (in other words, a double dose escalation) to establish an acceptable safety and activity window, in other words, a dose range that is relatively free of toxicity as well as active against the tumor, although the primary purpose of this study is to assess or evaluate safety. The reason or rationale to "add on" RRx-001 to radiotherapy and TMZ, which is described in more detail below on this page, is as follows: RRx-001 i
Interventions
- RADIATION Radiation
- DRUG RRx-001 dose escalation with TMZ + RT
- DRUG Fixed dose Temozolomide (75 mg/m2)
- DRUG TMZ Maintenance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-02-14 |
| Est. Completion | 2021-09-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02871843
The ClinicalTrials.gov registry entry for NCT02871843 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EpicentRx, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Radiation is the first listed.
NCT02871843 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02871843 about?
NCT02871843 is a clinical study titled "RRx-001 + Radiation + Temozolomide In Newly Diagnosed Glioblastoma and Anaplastic Gliomas". This is a two-part Phase I add-on clinical trial in newly diagnosed glioblastoma or GBM. By "add-on" what is meant is that the experimental intravenous therapy, RRx-001, is combined or "added on" to standard of care. In newly diagnosed GBM standard of care consists of radiotherapy + temozolomide (TM...
What is the current status of trial NCT02871843?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2017-02-14. Estimated completion is 2021-09-19.
What interventions are being tested in trial NCT02871843?
The interventions under investigation include: Radiation (RADIATION), RRx-001 dose escalation with TMZ + RT (DRUG), Fixed dose Temozolomide (75 mg/m2) (DRUG), TMZ Maintenance (DRUG).
Who is sponsoring clinical trial NCT02871843?
This trial is sponsored by EpicentRx, which has 15 total clinical trials registered on ClinicalTrials.gov.
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