Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer
Public ClinicalTrials.gov record NCT00733850. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection Plus Gemcitabine (G+K) Versus Gemcitabine in Patients With Advanced Pancreatic Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00733850
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 85 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2008
- Primary completion
- May 31, 2014
- Completion
- May 31, 2014
- Last update posted
- Jun 18, 2015
2008 – 2014
United States locations
- U.S. sites
- 42
- U.S. states
- 21
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwest Alabama Cancer Center | Muscle Shoals | Alabama | 35661 | — |
| Donald W. Hill, MD | Casa Grande | Arizona | 85222 | — |
| East Valley Hematology & Oncology Medical Group | Burbank | California | 91505 | — |
| The Oncology Institute of Hope and Innovation | Downey | California | 90241 | — |
| Cancer Care Associates of Fresno Medical Group (California Cancer Care) | Fresno | California | 93720 | — |
| Loma Linda Oncology Medical Group, Inc. | Redlands | California | 92374 | — |
| Cancer Prevention and Treatment Center | Soquel | California | 95073 | — |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | — |
| Broward Oncology Associates | Fort Lauderdale | Florida | 33308 | — |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | — |
| Pasco Pinellas Cancer Center | New Port Richey | Florida | 34652 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Medical and Surgical Specialists | Galesburg | Illinois | 61401 | — |
| Hematology / Oncology of the North Shore | Skokie | Illinois | 60076 | — |
| Hematology Oncology of Indiana | Indianapolis | Indiana | 46260 | — |
| McFarland Clinic | Ames | Iowa | 50010 | — |
| Kentuckiana Cancer Institute | Louisville | Kentucky | 40202 | — |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70509 | — |
| Research Medical Center | Kansas City | Missouri | 64132 | — |
| Southeast Nebraska Hematology & Oncology Consultants | Lincoln | Nebraska | 68510 | — |
| Las Vegas Cancer Center | Henderson | Nevada | 89052 | — |
| New Jersey Hematology Oncology Associates | Brick | New Jersey | 08724 | — |
| Regional Cancer Care Associates | Howell Township | New Jersey | 07731 | — |
| Atlantic Hematology Oncology Associates | Manasquam | New Jersey | 08736 | — |
| North Shore Hematology Oncology Associates | East Setauket | New York | 11733 | — |
| Arena Oncology Associates | Lake Success | New York | 11042 | — |
| Morton Coleman, MD | New York | New York | 10021 | — |
| Abraham Mittelman, MD | Purchase | New York | 10577 | — |
| Richmond University Medical Center | Staten Island | New York | 10310 | — |
| Bruckner Oncology | The Bronx | New York | 10469 | — |
| Southeastern Medical Oncology Center | Goldsboro | North Carolina | 27534 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| Promedica Cancer Institute | Sylvania | Ohio | 43560 | — |
| Hematology and Oncology Associates of NE PA | Dunmore | Pennsylvania | 18512 | — |
| Central Pennsylvania Hematology and Medical Oncology Assoc | Lemoyne | Pennsylvania | 17043 | — |
| The West Clinic | Memphis | Tennessee | 38120 | — |
| Oncology Consultants PA | Houston | Texas | 77024 | — |
| Oncology Consultants | Houston | Texas | 77024 | — |
| St. Luke's Cancer Center | Houston | Texas | 77030 | — |
| Blood And Cancer Center of East Texas | Tyler | Texas | 75701 | — |
| Tyler Hematology Oncology | Tyler | Texas | 75701 | — |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00733850, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 18, 2015 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00733850 live on ClinicalTrials.gov.