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NCT02107235 · ClinicalTrials.gov registry record · Phase 1
Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer
A Phase 1 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02107235: Completed Phase 1 study, sponsored by Traws Pharma.
NCT02107235 is a Phase 1 study that has completed, run by Traws Pharma. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02107235, a Phase 1 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The working hypothesis is that oral rigosertib treatment when added to platinum-based Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck Squamous Cell Carcinoma. This study will determine the highest safe dose of oral rigosertib that can be used with cisplatin and CRT. This study will also record any side effects that may occur and measure tumor sizes and how long patients live.
Primary Outcome
The primary objective of the study is to determine the maximum tolerated dose (MTD) of oral rigosertib when administered with platinum-based chemoradiotherapy to patients with intermediate- and high-risk Head and Neck Squamous Cell Carcinoma. The MTD is defined as the dose level immediately below that at which 2 or more patients experience a dose limiting toxicity (DLT).
Interventions
- RADIATION Radiotherapy
- DRUG cisplatin
- DRUG oral rigosertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT02107235 record still lists
NCT02107235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Radiotherapy is the first listed.
NCT02107235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02107235 about?
NCT02107235 is a clinical study titled "Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer". The working hypothesis is that oral rigosertib treatment when added to platinum-based Chemoradiotherapy (CRT) will improve progression-free survival for first-line patients with intermediate- or high-risk human papillomavirus negative positive (HPV (+)) Head and Neck Squamous Cell Carcinoma. This st...
What is the current status of trial NCT02107235?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2014-01. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02107235?
The interventions under investigation include: Radiotherapy (RADIATION), cisplatin (DRUG), oral rigosertib (DRUG).
Who is sponsoring clinical trial NCT02107235?
This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02107235's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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