Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC) (TLH-202)

December 4, 2013 updated by: Tiltan Pharma Ltd.

A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam Medical Center
        • Contact:
        • Principal Investigator:
          • Dr. Avivit Peer, MD
      • Haifa, Israel
        • Recruiting
        • Bnei Tzion Medical Center
        • Contact:
        • Principal Investigator:
          • Prof. Ofer Nativ, MD
      • Tel Hashomer, Israel
      • Tel-Aviv, Israel
        • Recruiting
        • Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Dr. Eliahu Gez, MD
      • Tzrifin, Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118 (single arm)
Drug: Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS) measured 24 weeks after treatment initiation
Time Frame: 24 weeks and up to 3 years
24 weeks and up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients.
Time Frame: 52 weeks and up to 3 years
52 weeks and up to 3 years
Safety and tolerability
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tiltan Pharma Ltd.

Investigators

  • Study Director: Dan Goldstaub, PhD, Chief Operating Officer, Tiltan Pharma LtD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ANTICIPATED)

February 1, 2014

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (ESTIMATE)

May 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2013

Last Update Submitted That Met QC Criteria

December 4, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLH-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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