Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

NCT01483586 | Terminated Phase 2 DMC

• 1 other identifier: C10-069
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• prostate specific antigen doubling time (PSADT)

  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

  over 12 months on study drug

Secondary Outcomes (2)

• PSA objective response

  over 12 months on study drug

• KLTc intake compliance

  each month, up to 12 months on study drug

Study Arms (2)

KLTc high dose

EXPERIMENTAL

6 KLTc gelcaps taken four times a day

Drug: Kanglaite gelcap

KLTc low dose

EXPERIMENTAL

3 KLTc gelcaps taken four times a day

Drug: kanglaite gelcap

Interventions

Kanglaite gelcap DRUG

3 KLTc gelcap capsules four times a day throughout the study (12 months). Each gelcap contains .45g KLT per capsule

KLTc low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KangLaiTe USA: lead

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

Location

North Shore University

Evanston, Illinois, 60201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 1, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

US (5)