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NCT01183065 · ClinicalTrials.gov registry record · Phase 2
Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT01183065: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01183065 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01183065, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if the experimental drug pralatrexate with the vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer. The reason we are doing this study is because another drug called methotrexate has been used for a long time to treat head and neck cancer patients. Pralatrexate was designed by scientists to be a new drug that works better than methotrexate. Laboratory studies have shown that pralatrexate works better than methotrexate at killing cancer cells. Pralatrexate has already been studied in patients with other types of cancers, such as lymphoma and lung cancer. The results from those studies were promising. Pralatrexate was recently approved by the Food and Drug Administration (FDA) as a new treatment for a cancer called peripheral T cell lymphoma.
Primary Outcome
by RECIST version 1.1 criteria
Interventions
- DRUG Pralatrexate With Vitamin B12 and Folic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01183065 record still lists
NCT01183065 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Pralatrexate With Vitamin B12 and Folic Acid is the first listed.
NCT01183065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01183065 about?
NCT01183065 is a clinical study titled "Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)". The purpose of this study is to find out if the experimental drug pralatrexate with the vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer. The reason we are doing this study is because another drug called methotrexate has been used for a long time to treat ...
What is the current status of trial NCT01183065?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2010-08. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01183065?
The interventions under investigation include: Pralatrexate With Vitamin B12 and Folic Acid (DRUG).
Who is sponsoring clinical trial NCT01183065?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01183065's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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