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NCT00733850 · ClinicalTrials.gov registry record · Phase 2
Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer
A Phase 2 study of Pancreatic Cancer, sponsored by KangLaiTe U.
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
- 20
- Study locations
NCT00733850: Completed Phase 2 study of Pancreatic Cancer, sponsored by KangLaiTe U.
NCT00733850 is a Phase 2 study of Pancreatic Cancer that has completed, run by KangLaiTe U. The registered enrollment target is 85 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00733850, a Phase 2 study of Pancreatic Cancer, has completed, sponsored by KangLaiTe U.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
- 20
- Study locations
Study Summary
Gemcitabine is usually used to treat cancer of the pancreas. The purpose of this study is to determine if Kanglaite Injection (KLT) is safe in patients with cancer of the pancreas, and whether it improves the effectiveness of gemcitabine. Additionally, the effect, if any, of KLT on the signs and symptoms of cancer as well as the common side effects of chemotherapy will be evaluated. The research drug, KLT, is purified from a traditional Chinese medicine called coix seed. It is approved in China for use in combination with chemotherapy to treat patients with advanced lung cancer and liver cancer. It is also approved in China for use by itself to treat the symptoms of cancer in patients with advanced cancer of any kind. In the US, KLT is purely experimental and is not approved for any use. While a small number of cancer patients in the US have received KLT alone in a Phase I study, this is the first US protocol to evaluate whether or not KLT is useful in pancreatic cancer. This phase II clinical study was completed in the US in June 2014. The clinical study report was submitted to the FDA in January 2015. The designs of the phase III clinical study for KLT has been cleared by the FDA in May 2015 and will be launched soon.
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Kanglaite Injection plus gemcitabine
Study Locations (20)
California
- East Valley Hematology & Oncology Medical Group - Burbank
- The Oncology Institute of Hope and Innovation - Downey
- Cancer Care Associates of Fresno Medical Group (California Cancer Care) - Fresno
- Loma Linda Oncology Medical Group, Inc. - Redlands
- Cancer Prevention and Treatment Center - Soquel
Florida
- Broward Oncology Associates - Fort Lauderdale
- Baptist Cancer Institute - Jacksonville
- Pasco Pinellas Cancer Center - New Port Richey
- Tampa General Hospital - Tampa
Illinois
- Medical and Surgical Specialists - Galesburg
- Hematology / Oncology of the North Shore - Skokie
Alabama
- Northwest Alabama Cancer Center - Muscle Shoals
Arizona
- Donald W. Hill, MD - Casa Grande
Connecticut
- Norwalk Hospital - Norwalk
Indiana
- Hematology Oncology of Indiana - Indianapolis
Iowa
- McFarland Clinic - Ames
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2008-08 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT00733850 record still lists
NCT00733850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT00733850 names 20 study sites across 12 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00733850 about?
NCT00733850 is a clinical study titled "Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer". Gemcitabine is usually used to treat cancer of the pancreas. The purpose of this study is to determine if Kanglaite Injection (KLT) is safe in patients with cancer of the pancreas, and whether it improves the effectiveness of gemcitabine. Additionally, the effect, if any, of KLT on the signs and sym...
What is the current status of trial NCT00733850?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2008-08. Estimated completion is 2014-06.
What conditions does trial NCT00733850 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT00733850?
The interventions under investigation include: Gemcitabine (DRUG), Kanglaite Injection plus gemcitabine (DRUG).
Who is sponsoring clinical trial NCT00733850?
This trial is sponsored by KangLaiTe U, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00733850 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00733850's enrollment target sits among peer trials
85 115th of 278 higher than 163 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer 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.
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