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.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer (CRPC) Drug: Hamsa-1™ TL-118 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
Study Start Date : March 2009
Estimated Primary Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118 (single arm)
Drug: Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118

Primary Outcome Measures :
  1. Progression free survival (PFS) measured 24 weeks after treatment initiation [ Time Frame: 24 weeks and up to 3 years ]

Secondary Outcome Measures :
  1. Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients. [ Time Frame: 52 weeks and up to 3 years ]
  2. Safety and tolerability [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00684970

Contact: Dan Goldstaub, Ph.D. 972-54-555-8573

Bnei Tzion Medical Center Recruiting
Haifa, Israel
Contact: Prof. Ofer Nativ   
Principal Investigator: Prof. Ofer Nativ, MD         
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Avivit Peer, MD   
Principal Investigator: Dr. Avivit Peer, MD         
Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Dr. Raanan Berger, M.D.   
Principal Investigator: Dr. Raanan Berger, MD, PhD         
Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Contact: Dr. Eliahu Gez, MD   
Principal Investigator: Dr. Eliahu Gez, MD         
Asaf Harofe Medical Center Recruiting
Tzrifin, Israel
Contact: Prof. Avishay Sella, MD   
Principal Investigator: Prof. Avishay Sella, MD         
Sponsors and Collaborators
Tiltan Pharma Ltd.
Study Director: Dan Goldstaub, PhD Chief Operating Officer, Tiltan Pharma LtD

Responsible Party: Tiltan Pharma Ltd. Identifier: NCT00684970     History of Changes
Other Study ID Numbers: TLH-202
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: December 2013

Keywords provided by Tiltan Pharma Ltd.:
metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents, Non-Steroidal