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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2013 by Tiltan Pharma Ltd..
Recruitment status was  Recruiting
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
  Purpose
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 Intervention Phase
Metastatic Castration Resistant Prostate Cancer (CRPC)
Drug: Hamsa-1™ TL-118
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Tiltan Pharma Ltd.:

Primary Outcome Measures:
  • Progression free survival (PFS) measured 24 weeks after treatment initiation [ Time Frame: 24 weeks and up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118 (single arm)
Drug: Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684970

Contacts
Contact: Dan Goldstaub, Ph.D. 972-54-555-8573 dan@tiltanpharma.com

Locations
Israel
Bnei Tzion Medical Center Recruiting
Haifa, Israel
Contact: Prof. Ofer Nativ       ofer.nativ@b-zion.org.il   
Principal Investigator: Prof. Ofer Nativ, MD         
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Avivit Peer, MD       a_peer@rambam.health.gov.il   
Principal Investigator: Dr. Avivit Peer, MD         
Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Dr. Raanan Berger, M.D.       Raanan.Berger@sheba.health.gov.il   
Principal Investigator: Dr. Raanan Berger, MD, PhD         
Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Contact: Dr. Eliahu Gez, MD       eliahug@tasmc.health.gov.il   
Principal Investigator: Dr. Eliahu Gez, MD         
Asaf Harofe Medical Center Recruiting
Tzrifin, Israel
Contact: Prof. Avishay Sella, MD       Dr.AvishaySella@asaf.health.gov.il   
Principal Investigator: Prof. Avishay Sella, MD         
Sponsors and Collaborators
Tiltan Pharma Ltd.
Investigators
Study Director: Dan Goldstaub, PhD Chief Operating Officer, Tiltan Pharma LtD
  More Information

Responsible Party: Tiltan Pharma Ltd.
ClinicalTrials.gov Identifier: NCT00684970     History of Changes
Other Study ID Numbers: TLH-202 
Study First Received: May 22, 2008
Last Updated: December 4, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
United States: Food and Drug Administration

Keywords provided by Tiltan Pharma Ltd.:
CRPC
HRPC
metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cimetidine
Diclofenac
Sulfasalazine
Cyclophosphamide
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

ClinicalTrials.gov processed this record on September 23, 2016