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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00684970
Recruitment Status : Unknown
Verified December 2013 by Tiltan Pharma Ltd..
Recruitment status was:  Recruiting
First Posted : May 28, 2008
Last Update Posted : December 5, 2013
Information provided by (Responsible Party):
Tiltan Pharma Ltd.

May 22, 2008
May 28, 2008
December 5, 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 ]
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 ]
Complete list of historical versions of study NCT00684970 on 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 ]
  • Safety and tolerability [ Time Frame: Throughout study ]
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 ]
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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.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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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