Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC) (TLH-202)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Tiltan Pharma Ltd.
Sponsor:
Information provided by (Responsible Party):
Tiltan Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT00684970
First received: May 22, 2008
Last updated: December 4, 2013
Last verified: December 2013

May 22, 2008
December 4, 2013
March 2009
February 2014   (final data collection date for primary outcome measure)
Progression free survival (PFS) measured 24 weeks after treatment initiation [ Time Frame: 24 weeks and up to 3 years ] [ Designated as safety issue: No ]
Primary Endpoint at 16 weeks: Median time to progression, where progression is defined as an increase of PSA level of 25% or greater above baseline or other evidence of disease progression. Primary Endpoint at 52 weeks: Median overall survival. [ Time Frame: 16 weeks and 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00684970 on ClinicalTrials.gov Archive Site
  • Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients. [ Time Frame: 52 weeks and up to 3 years ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Proportion of patients with objective response within 16 weeks. Where response is defined as a decrease of 50% or more in PSA without evidence of disease progression otherwise [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)

Hamsa-1™ is an anti-angiogenic drug combination designed for the treatment of cancer. The investigational product Hamsa-1™ comprises of four well-known active components. The therapy is administrated at a unique dosing regimen that was found to be effective and advantageous in terms of safety.The product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. This Phase IIb clinical trial aims to evaluate the efficacy of Hamsa-1™ for the treatment of metastatic Castration Resistant Prostate Cancer (CRPC) patients.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Castration Resistant Prostate Cancer (CRPC)
Drug: Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118
Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118 (single arm)
Intervention: Drug: Hamsa-1™ TL-118
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects willing and able to give written informed consent
  2. Confirmed metastatic castration resistant prostate cancer and rising PSA
  3. ECOG performance status ≤ 1
  4. Adequate renal function, hepatic function and bone marrow reserve.
  5. Subjects capable of swallowing.

Exclusion Criteria:

  1. Hypersensitivity to one or more of the Hamsa-1™ active components
  2. Glucose-6-phosphate-dehydrogenase deficiency (G6PD)
  3. Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
  4. Subjects who received any investigational medication, antineoplastic therapy, or any significant change in treatment within 1 month prior to screening
  5. Subjects with visceral metastases (e.g. liver, lung)
  6. Subjects who received more than 2 prior chemotherapies for the treatment of prostate cancer
  7. Subjects suffering from circumstances likely to interfere with absorption of orally administrated drugs
  8. Subjects unwilling to or unable to comply with study protocol
Male
18 Years and older
No
Contact: Dan Goldstaub, Ph.D. 972-54-555-8573 dan@tiltanpharma.com
Israel
 
NCT00684970
TLH-202
Yes
Tiltan Pharma Ltd.
Tiltan Pharma Ltd.
Not Provided
Study Director: Dan Goldstaub, PhD Chief Operating Officer, Tiltan Pharma LtD
Tiltan Pharma Ltd.
December 2013

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