Clinical trial NCT00684970: Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
Official title: A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Castration Resistant Prostate Cancer (CRPC)
Keywords: CRPC
HRPC
metastatic prostate cancer
Lead sponsor: Tiltan Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Progression free survival (PFS) measured 24 weeks after treatment initiation
timeFrame: 24 weeks and up to 3 years
Secondary outcomes:
measure: Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients.
timeFrame: 52 weeks and up to 3 years
measure: Safety and tolerability
timeFrame: Throughout study
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnei Tzion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Tzrifin
country: Israel
facility: Asaf Harofe Medical Center
Study officials:
affiliation: Chief Operating Officer, Tiltan Pharma LtD
name: Dan Goldstaub, PhD
role: STUDY_DIRECTOR
References: