Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02422979 · ClinicalTrials.gov registry record · Phase 1
Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer
A Phase 1 study, sponsored by Rakuten Medical.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02422979 is a Phase 1 study that has completed, run by Rakuten Medical. The registered enrollment target is 40 participants.
The verdict
NCT02422979, a Phase 1 study, has completed, sponsored by Rakuten Medical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a two-part clinical study of patients with recurrent Head and Neck Cancer (HNC), who in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy. The purpose of the study is to determine the safety and anti-cancer activity of various doses and repeated cycles of the experimental treatment using the study drug RM-1929 and fixed amounts of red light applied at the tumor site to activate the pharmacodynamics of the drug. The part 1 of the study has been completed and consisted in a single cycle, 3+3 dose escalation safety study of the experimental drug RM-1929 using a fixed amount of 690 nm red light. The part 1 was designed to determine the safety of the treatment as set by the maximal feasible dose or the maximal tolerable dose of RM-1929. From the part 1 results, the maximal feasible dose of RM-1929 was determined. The part 2 of the study is currently ongoing and it is evaluating the safety and anticancer efficacy of up to four repeated treatments of Photoimmunotherapy with RM-1929 at the maximal feasible dose of RM-1929 activated with a fixed amount of red light.
Interventions
- COMBINATION_PRODUCT PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 160 mg/m^2
- COMBINATION_PRODUCT PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 320 mg/m^2
- COMBINATION_PRODUCT PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640 mg/m^2
- COMBINATION_PRODUCT PIT: 75 J/cm^2 for superficial lesions or 150 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2
- COMBINATION_PRODUCT PIT: 100 J/cm^2 for superficial lesions or 200 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-06 |
| Est. Completion | 2019-02-25 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02422979
The ClinicalTrials.gov registry entry for NCT02422979 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rakuten Medical, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 160 mg/m^2 is the first listed.
NCT02422979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02422979 about?
NCT02422979 is a clinical study titled "Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer". This is a two-part clinical study of patients with recurrent Head and Neck Cancer (HNC), who in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy. The purpose of the study is to determine the safety and anti-cancer activity of various d...
What is the current status of trial NCT02422979?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2015-06. Estimated completion is 2019-02-25.
What interventions are being tested in trial NCT02422979?
The interventions under investigation include: PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 160 mg/m^2 (COMBINATION_PRODUCT), PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 320 mg/m^2 (COMBINATION_PRODUCT), PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640 mg/m^2 (COMBINATION_PRODUCT), PIT: 75 J/cm^2 for superficial lesions or 150 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2 (COMBINATION_PRODUCT), PIT: 100 J/cm^2 for superficial lesions or 200 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT02422979?
This trial is sponsored by Rakuten Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.