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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Once daily Hamsa-1™ TL-118
Bnei Tzion Medical Center
Haifa, Israel
RECRUITINGRambam Medical Center
Haifa, Israel
RECRUITINGSourasky Medical Center
Tel Aviv, Israel
RECRUITINGSheba Medical Center
Tel Litwinsky, Israel
RECRUITINGAsaf Harofe Medical Center
Tzrifin, Israel
RECRUITINGProgression free survival (PFS) measured 24 weeks after treatment initiation
Time frame: 24 weeks and up to 3 years
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
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