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Pancreatic CancerPhase 2NCT00733850

Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer

A Phase 2 study testing Kanglaite Injection plus gemcitabine and Gemcitabine in people with Pancreatic Cancer, run by KangLaiTe USA at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Kanglaite Injection plus gemcitabine and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
42 sitesUnited States
Study dates
Aug 2008to Jun 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have a life expectancy of at least 84 days (12 weeks)
  • Must be ambulatory and have either a Karnofsky performance status of 60 or higher or ECOG performance status of 0, 1 or 2
  • Must have histologically confirmed pancreatic cancer, either locally invasive or metastatic, and not amenable to potentially curative resection
  • Must have measurable or evaluable target lesions, by RECIST 1.1 criteria
  • Must not have previously received chemotherapy for metastatic disease
  • If female, must have negative pregnancy test, be at least one year post menopausal, or have undergone surgical sterilization and must be willing to use appropriate birth control measures unless post menopausal or post surgical sterilization
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  • Must be judged by the Investigator to have the initiative and means to be compliant with the protocol including the return for follow-up visits on schedule
  • Must give written informed consent prior to any testing under this protocol
  • Must have Hemoglobin > 9 gm/dl, WBC>2 x109/ml, and platelets >100,000/ul
  • Must have Alkaline Phosphatase < 2.5 x ULN, ALT < 2.0 x ULN, AST< 2.0 x ULN and bilirubin < 2.0
  • Must have stable renal function appropriate for age. A patient must have a serum creatinine of < 1.5mg/dl or a GFR > 60 mL/minute
  • Must have a central venous catheter if randomized to the G + K arm of study, or if the patient does not have one, must agree to have one placed if randomized to the G+K arm.

Who cannot join

  • Patient has a history of cancer within 5 years other than pancreatic cancer (excluding resected non melanoma skin carcinoma
  • Patient has active (untreated or still receiving corticosteroids) brain metastases
  • Patient has had prior chemotherapy for metastatic disease
  • Patient has received prior gemcitabine < 12 months previously
  • Patient is currently taking a bile acid sequestrant drug (such as Questran, Colestid or Welchol) or a fibric acid derivative drug (such as Lopid, Tricor, Antara, Lofibra and Trilipix) - Patients with disturbances of lipid metabolism such as pathologic hyperlipidemia (including congenital hypertriglyceridemia or cholesterolemia), lipoid nephrosis, or acute pancreatitis
  • Patient has uncontrolled Type 1 or 2 diabetes mellitus
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  • Patient has another active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome (e.g., survival) evaluation of the study drugs
  • Patient or physician plans surgical treatment of malignancy, radiation therapy, or biological treatment for cancer including immunotherapy while on study, other than surgical bypass or stent insertion for relief of bile flow blockage
  • Patient has a known allergy to soybeans (used in production of Kanglaite Injection) or Job's Tear (source of active ingredient of Kanglaite Injection), or to gemcitabine
  • Patient has NYHA congestive heart failure Class II or higher from any cause
  • Patient has unstable angina or history of an MI within 12 months
  • Patient is pregnant or lactating
  • Patient has used or plans to use another investigational agent within four weeks prior to screening through the entire study period including study termination and the follow-up visits.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • McFarland Clinic

    Ames, Iowa, 50010

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70509

  • New Jersey Hematology Oncology Associates

    Brick, New Jersey, 08724

  • East Valley Hematology & Oncology Medical Group

    Burbank, California, 91505

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Donald W. Hill, MD

    Casa Grande, Arizona, 85222

  • The Oncology Institute of Hope and Innovation

    Downey, California, 90241

  • Hematology and Oncology Associates of NE PA

    Dunmore, Pennsylvania, 18512

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Broward Oncology Associates

    Fort Lauderdale, Florida, 33308

  • Cancer Care Associates of Fresno Medical Group (California Cancer Care)

    Fresno, California, 93720

  • Medical and Surgical Specialists

    Galesburg, Illinois, 61401

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Las Vegas Cancer Center

    Henderson, Nevada, 89052

  • Oncology Consultants PA

    Houston, Texas, 77024

  • Oncology Consultants

    Houston, Texas, 77024

  • St. Luke's Cancer Center

    Houston, Texas, 77030

  • Regional Cancer Care Associates

    Howell Township, New Jersey, 07731

  • Hematology Oncology of Indiana

    Indianapolis, Indiana, 46260

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Arena Oncology Associates

    Lake Success, New York, 11042

  • Central Pennsylvania Hematology and Medical Oncology Assoc

    Lemoyne, Pennsylvania, 17043

  • Southeast Nebraska Hematology & Oncology Consultants

    Lincoln, Nebraska, 68510

  • Kentuckiana Cancer Institute

    Louisville, Kentucky, 40202

  • Atlantic Hematology Oncology Associates

    Manasquam, New Jersey, 08736

  • The West Clinic

    Memphis, Tennessee, 38120

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Pasco Pinellas Cancer Center

    New Port Richey, Florida, 34652

  • Morton Coleman, MD

    New York, New York, 10021

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Abraham Mittelman, MD

    Purchase, New York, 10577

  • Loma Linda Oncology Medical Group, Inc.

    Redlands, California, 92374

  • Hematology / Oncology of the North Shore

    Skokie, Illinois, 60076

  • Cancer Prevention and Treatment Center

    Soquel, California, 95073

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • Promedica Cancer Institute

    Sylvania, Ohio, 43560

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Bruckner Oncology

    The Bronx, New York, 10469

  • Blood And Cancer Center of East Texas

    Tyler, Texas, 75701

  • Tyler Hematology Oncology

    Tyler, Texas, 75701

Other trials in United States

About this study

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

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.

Being tested
Kanglaite Injection plus gemcitabine, Gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kanglaite Injection plus gemcitabineDrug

    Also called KLT

    Intravenous repeating dose

  • GemcitabineDrug

    Also called Gemzar

    Intravenous repeating dose

Study groups in NCT00733850
Study groupRoleWhat they receive
1ExperimentalKanglaite Injection plus Gemcitabine
Receives: Drug: Kanglaite Injection plus gemcitabine
2Active comparatorGemcitabine
Receives: Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: Length of study

Secondary outcomes (2)

  1. Objective Response Rate

    Measured: Length of study

  2. Survival

    Measured: From randomization until death from any cause

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00733850
Sponsor's protocol ID
KLT-PANC-001
Status last verified
Jun 2015
First submitted
11 Aug 2008
Last updated
19 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Schwartzberg LS, Arena FP, Bienvenu BJ, Kaplan EH, Camacho LH, Campos LT, Waymack JP, Tagliaferri MA, Chen MM, Li D. A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection (KLTi) plus Gemcitabine versus Gemcitabine in Patients with Advanced Pancreatic Cancer. J Cancer. 2017 Jul 3;8(10):1872-1883. doi: 10.7150/jca.15407. eCollection 2017.

    PubMed 28819385

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Kanglaite Injection plus gemcitabine and Gemcitabine in people with Pancreatic Cancer, run by KangLaiTe USA at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Length of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00733850, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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