Trial record 1 of 4 for:    kanglaite
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Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
KangLaiTe USA
ClinicalTrials.gov Identifier:
NCT01483586
First received: November 28, 2011
Last updated: April 11, 2014
Last verified: April 2014

November 28, 2011
April 11, 2014
November 2011
December 2013   (final data collection date for primary outcome measure)
prostate specific antigen doubling time (PSADT) [ Time Frame: over 12 months on study drug ] [ Designated as safety issue: No ]
PSADT is defined as the natural log of 2 (0.693)divided by the slope (beta- rate of change) of the relationship between the log of PSA and the time of PSA measurement using linear regression model
prostate specific antigen doubling time (PSADT) [ Time Frame: during 12 months of study period ] [ Designated as safety issue: No ]
PSADT is defined as the natural log of 2 (0.693)divided by the slope (beta- rate of change) of the relationship between the log of PSA and the time of PSA measurement using linear regression model
Complete list of historical versions of study NCT01483586 on ClinicalTrials.gov Archive Site
  • PSA objective response [ Time Frame: over 12 months on study drug ] [ Designated as safety issue: No ]
    a 50% or more decline in PSA level compared to baseline
  • KLTc intake compliance [ Time Frame: each month, up to 12 months on study drug ] [ Designated as safety issue: No ]
    actual number of capsules taken divided by the expected number of capsules taken multiplied by 100 to get a percentage of compliance
  • PSA objective response [ Time Frame: during 12 months of study ] [ Designated as safety issue: No ]
    a 50% or more decline in PSA level compared to baseline
  • KLTc intake compliance [ Time Frame: each month, up to 12 months of study period ] [ Designated as safety issue: No ]
    actual number of capsules taken divided by the expected number of capsules taken multiplied by 100 to get a percentage of compliance
Not Provided
Not Provided
 
Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer
Efficacy and Safety of Oral Kanglaite (KLTc)in Men With Prostate Cancer: Randomized, Dose-Ranging Study of the Effects of KLTc on Prostate Specific Antigen (PSA) Doubling Time Among Men With Rising PSA Levels After Definitive Local Therapy

This research is being done to evaluate the safety and efficacy of the investigational Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: kanglaite gelcap
    3 KLTc gelcap capsules four times a day throughout the study (12 months). Each gelcap contains .45g KLT per capsule
  • Drug: Kanglaite gelcap
    6 KLTc gelcaps taken four times a day throughout the study (12 months). Each gelcap contains .45g KLT
  • Experimental: KLTc high dose
    6 KLTc gelcaps taken four times a day
    Intervention: Drug: Kanglaite gelcap
  • Experimental: KLTc low dose
    3 KLTc gelcaps taken four times a day
    Intervention: Drug: kanglaite gelcap
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
90
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • confirmed adenocarcinoma of the prostate
  • undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor with a rising PSA
  • life expectancy greater than 6 months
  • has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc.) has been stable for at least 2 months prior to screening and the patient agrees not to stop or change the dose while participating in the study.
  • Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper institutional limits of normal, ALT and AST ≤ 2.5 times the upper institutional limits of normal
  • Adequate renal function with serum creatinine ≤ 1.5 times the upper institutional limits of normal
  • Adequate hematologic function (absolute neutrophil counts ≥ 1,500 mm3 and platelets ≥ 100,000 mm3)
  • All electrolytes (including potassium, sodium, and serum or ionized calcium) must be within normal limits

Exclusion Criteria:

  • Patients with evidence of metastatic disease would be excluded, except for presence of positive lymph nodes from the surgical pathology. Similarly, patients with radiological evidence of lymph nodes < 2 cm that lack pathological confirmation would be eligible
  • Patients with a PSA doubling time of <6months at screening would be excluded
  • Patients meeting Phoenix criteria for biochemical failure (nadir + ≥2ng/mL increase in serum PSA) who wish additional conventional therapy
  • Any concurrent malignancy other than adequately treated basal or squamous cell skin cancer or superficial bladder cancer
  • Any psychiatric or other disorders such as dementia that would prohibit the patient from understanding or rendering informed consent or from fully complying with protocol treatment and follow-up
  • Inability to swallow capsules
  • Patients with a known history of gastrointestinal disease, surgery or malabsorption that could potentially impact the absorption of the study drug
  • Patients requiring the use of a feeding tube
  • Receipt of prior chemotherapy
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01483586
C10-069
Yes
KangLaiTe USA
KangLaiTe USA
Not Provided
Not Provided
KangLaiTe USA
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP