Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC) (TLH-202)
Primary Purpose
Metastatic Castration Resistant Prostate Cancer (CRPC)
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Hamsa-1™ TL-118
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer (CRPC) focused on measuring CRPC, HRPC, metastatic prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects willing and able to give written informed consent
- Confirmed metastatic castration resistant prostate cancer and rising PSA
- ECOG performance status ≤ 1
- Adequate renal function, hepatic function and bone marrow reserve.
- Subjects capable of swallowing.
Exclusion Criteria:
- Hypersensitivity to one or more of the Hamsa-1™ active components
- Glucose-6-phosphate-dehydrogenase deficiency (G6PD)
- Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
- Subjects who received any investigational medication, antineoplastic therapy, or any significant change in treatment within 1 month prior to screening
- Subjects with visceral metastases (e.g. liver, lung)
- Subjects who received more than 2 prior chemotherapies for the treatment of prostate cancer
- Subjects suffering from circumstances likely to interfere with absorption of orally administrated drugs
- Subjects unwilling to or unable to comply with study protocol
Sites / Locations
- Bnei Tzion Medical CenterRecruiting
- Rambam Medical CenterRecruiting
- Sheba Medical CenterRecruiting
- Sourasky Medical CenterRecruiting
- Asaf Harofe Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hamsa-1™ TL-118
Arm Description
Once daily Hamsa-1™ TL-118 (single arm)
Outcomes
Primary Outcome Measures
Progression free survival (PFS) measured 24 weeks after treatment initiation
Secondary Outcome Measures
Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients.
Safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00684970
Brief Title
Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
Acronym
TLH-202
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
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tiltan Pharma Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration Resistant Prostate Cancer (CRPC)
Keywords
CRPC, HRPC, metastatic prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hamsa-1™ TL-118
Arm Type
Other
Arm Description
Once daily Hamsa-1™ TL-118 (single arm)
Intervention Type
Drug
Intervention Name(s)
Hamsa-1™ TL-118
Intervention Description
Once daily Hamsa-1™ TL-118
Primary Outcome Measure Information:
Title
Progression free survival (PFS) measured 24 weeks after treatment initiation
Time Frame
24 weeks and up to 3 years
Secondary Outcome Measure Information:
Title
Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients.
Time Frame
52 weeks and up to 3 years
Title
Safety and tolerability
Time Frame
Throughout study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects willing and able to give written informed consent
Confirmed metastatic castration resistant prostate cancer and rising PSA
ECOG performance status ≤ 1
Adequate renal function, hepatic function and bone marrow reserve.
Subjects capable of swallowing.
Exclusion Criteria:
Hypersensitivity to one or more of the Hamsa-1™ active components
Glucose-6-phosphate-dehydrogenase deficiency (G6PD)
Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
Subjects who received any investigational medication, antineoplastic therapy, or any significant change in treatment within 1 month prior to screening
Subjects with visceral metastases (e.g. liver, lung)
Subjects who received more than 2 prior chemotherapies for the treatment of prostate cancer
Subjects suffering from circumstances likely to interfere with absorption of orally administrated drugs
Subjects unwilling to or unable to comply with study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Goldstaub, Ph.D.
Phone
972-54-555-8573
Email
dan@tiltanpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Goldstaub, PhD
Organizational Affiliation
Chief Operating Officer, Tiltan Pharma LtD
Official's Role
Study Director
Facility Information:
Facility Name
Bnei Tzion Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Ofer Nativ
Email
ofer.nativ@b-zion.org.il
First Name & Middle Initial & Last Name & Degree
Prof. Ofer Nativ, MD
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avivit Peer, MD
Email
a_peer@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Dr. Avivit Peer, MD
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Raanan Berger, M.D.
Email
Raanan.Berger@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Dr. Raanan Berger, MD, PhD
Facility Name
Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Eliahu Gez, MD
Email
eliahug@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Dr. Eliahu Gez, MD
Facility Name
Asaf Harofe Medical Center
City
Tzrifin
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Avishay Sella, MD
Email
Dr.AvishaySella@asaf.health.gov.il
First Name & Middle Initial & Last Name & Degree
Prof. Avishay Sella, MD
12. IPD Sharing Statement
Learn more about this trial
Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
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