Metastatic Castration Resistant Prostate Cancer (CRPC) Clinical Trial
— TLH-202Official title:
A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
| NCT number | NCT00684970 |
| Other study ID # | TLH-202 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 2 |
| First received | May 22, 2008 |
| Last updated | December 4, 2013 |
| Start date | March 2009 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Bnei Tzion Medical Center | Haifa | |
| Israel | Rambam Medical Center | Haifa | |
| Israel | Sheba Medical Center | Tel Hashomer | |
| Israel | Sourasky Medical Center | Tel-Aviv | |
| Israel | Asaf Harofe Medical Center | Tzrifin |
| Lead Sponsor | Collaborator |
|---|---|
| Tiltan Pharma Ltd. |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression free survival (PFS) measured 24 weeks after treatment initiation | 24 weeks and up to 3 years | No | |
| Secondary | Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients. | 52 weeks and up to 3 years | No | |
| Secondary | Safety and tolerability | Throughout study | Yes |