Status:
UNKNOWN
Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
Lead Sponsor:
Tiltan Pharma Ltd.
Conditions:
Metastatic Castration Resistant Prostate Cancer (CRPC)
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00684970
Start Date
March 1 2009
Last Update
December 5 2013
Active Locations (5)
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1
Bnei Tzion Medical Center
Haifa, Israel
2
Rambam Medical Center
Haifa, Israel
3
Sourasky Medical Center
Tel Aviv, Israel
4
Sheba Medical Center
Tel Litwinsky, Israel