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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: Completed Phase 1 study, sponsored by Rakuten Medical.
NCT02422979 is a Phase 1 study that has completed, run by Rakuten Medical. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine the MTD or MFD of RM-1929
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 |
What the finished NCT02422979 record still lists
NCT02422979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
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 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02422979's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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