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

NCT ID: NCT00684970

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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

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Conditions

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Metastatic Castration Resistant Prostate Cancer (CRPC)

Keywords

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CRPC HRPC metastatic prostate cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hamsa-1™ TL-118

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

Group Type OTHER

Hamsa-1™ TL-118

Intervention Type DRUG

Once daily Hamsa-1™ TL-118

Interventions

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Hamsa-1™ TL-118

Once daily Hamsa-1™ TL-118

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Tiltan Pharma Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Goldstaub, PhD

Role: STUDY_DIRECTOR

Chief Operating Officer, Tiltan Pharma LtD

Locations

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Bnei Tzion Medical Center

Haifa, , Israel

Site Status RECRUITING

Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

Asaf Harofe Medical Center

Tzrifin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Dan Goldstaub, Ph.D.

Role: CONTACT

Phone: 972-54-555-8573

Email: [email protected]

Facility Contacts

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Prof. Ofer Nativ

Role: primary

Avivit Peer, MD

Role: primary

Dr. Eliahu Gez, MD

Role: primary

Dr. Raanan Berger, M.D.

Role: primary

Prof. Avishay Sella, MD

Role: primary

Other Identifiers

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TLH-202

Identifier Type: -

Identifier Source: org_study_id