Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
TLH-202
A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
1 other identifier
interventional
100
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 28, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedDecember 5, 2013
December 1, 2013
4.9 years
May 22, 2008
December 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) measured 24 weeks after treatment initiation
24 weeks and up to 3 years
Secondary Outcomes (2)
Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients.
52 weeks and up to 3 years
Safety and tolerability
Throughout study
Study Arms (1)
Hamsa-1™ TL-118
OTHEROnce daily Hamsa-1™ TL-118 (single arm)
Interventions
Eligibility Criteria
You may qualify if:
- Subjects willing and able to give written informed consent
- Confirmed metastatic castration resistant prostate cancer and rising PSA
- ECOG performance status ≤ 1
- Adequate renal function, hepatic function and bone marrow reserve.
- Subjects capable of swallowing.
You may not qualify if:
- Hypersensitivity to one or more of the Hamsa-1™ active components
- Glucose-6-phosphate-dehydrogenase deficiency (G6PD)
- Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
- Subjects who received any investigational medication, antineoplastic therapy, or any significant change in treatment within 1 month prior to screening
- Subjects with visceral metastases (e.g. liver, lung)
- Subjects who received more than 2 prior chemotherapies for the treatment of prostate cancer
- Subjects suffering from circumstances likely to interfere with absorption of orally administrated drugs
- Subjects unwilling to or unable to comply with study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Bnei Tzion Medical Center
Haifa, Israel
Rambam Medical Center
Haifa, Israel
Sourasky Medical Center
Tel Aviv, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Asaf Harofe Medical Center
Tzrifin, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dan Goldstaub, PhD
Chief Operating Officer, Tiltan Pharma LtD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2008
First Posted
May 28, 2008
Study Start
March 1, 2009
Primary Completion
February 1, 2014
Last Updated
December 5, 2013
Record last verified: 2013-12