Metastatic Castration Resistant Prostate Cancer (CRPC)
Conditions
Keywords
CRPC, HRPC, metastatic prostate cancer
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.
Interventions
DRUGHamsa-1™ TL-118
Once daily Hamsa-1™ TL-118
Sponsors
Tiltan Pharma Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) measured 24 weeks after treatment initiation | 24 weeks and up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Israel
Contacts
Primary ContactDan Goldstaub, Ph.D.
Outcome results
None listed