Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)

Phase 2

• Conditions: Metastatic Castration Resistant Prostate Cancer (CRPC)
• Interventions: Drug: Hamsa-1™ TL-118

• Registration Number: NCT00684970
• Lead Sponsor: Tiltan Pharma Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Study Start: 2009-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-04
• Last Update Posted: 2013-12-05
• Primary Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hamsa-1™ TL-118	Hamsa-1™ TL-118	Once daily Hamsa-1™ TL-118 (single arm)

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS) measured 24 weeks after treatment initiation	24 weeks and up to 3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Rambam Medical Center; 🇮🇱 Haifa, Israel

Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel

Bnei Tzion Medical Center; 🇮🇱 Haifa, Israel

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Asaf Harofe Medical Center; 🇮🇱 Tzrifin, Israel