Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC) (TLH-202)
This study is currently recruiting participants.
Verified August 2011 by Tiltan Pharma Ltd.
Sponsor:
Tiltan Pharma Ltd.
Information provided by (Responsible Party):
Tiltan Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT00684970
First received: May 22, 2008
Last updated: August 21, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Castration Resistant Prostate Cancer (CRPC) |
Drug: Hamsa-1™ TL-118 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC) |
Resource links provided by NLM:
Further study details as provided by Tiltan Pharma Ltd.:
Primary Outcome Measures:
- Progression free survival (PFS) measured 24 weeks after treatment initiation [ Time Frame: 24 weeks and up to 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients. [ Time Frame: 52 weeks and up to 3 years ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118 (single arm)
|
Drug: Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684970
Contacts
| Contact: Dan Goldstaub, Ph.D. | 972-54-555-8573 | dan@tiltanpharma.com |
Locations
| Israel | |
| Rambam Medical Center | Recruiting |
| Haifa, Israel | |
| Contact: Avivit Peer, MD a_peer@rambam.health.gov.il | |
| Principal Investigator: Dr. Avivit Peer, MD | |
| Bnei Tzion Medical Center | Recruiting |
| Haifa, Israel | |
| Contact: Prof. Ofer Nativ ofer.nativ@b-zion.org.il | |
| Principal Investigator: Prof. Ofer Nativ, MD | |
| Sheba Medical Center | Recruiting |
| Tel Hashomer, Israel | |
| Contact: Dr. Raanan Berger, M.D. Raanan.Berger@sheba.health.gov.il | |
| Principal Investigator: Dr. Raanan Berger, MD, PhD | |
| Sourasky Medical Center | Recruiting |
| Tel-Aviv, Israel | |
| Contact: Dr. Eliahu Gez, MD eliahug@tasmc.health.gov.il | |
| Principal Investigator: Dr. Eliahu Gez, MD | |
| Asaf Harofe Medical Center | Recruiting |
| Tzrifin, Israel | |
| Contact: Prof. Avishay Sella, MD Dr.AvishaySella@asaf.health.gov.il | |
| Principal Investigator: Prof. Avishay Sella, MD | |
Sponsors and Collaborators
Tiltan Pharma Ltd.
Investigators
| Study Director: | Dan Goldstaub, PhD | Chief Operating Officer, Tiltan Pharma LtD |
More Information
No publications provided
| Responsible Party: | Tiltan Pharma Ltd. |
| ClinicalTrials.gov Identifier: | NCT00684970 History of Changes |
| Other Study ID Numbers: | TLH-202 |
| Study First Received: | May 22, 2008 |
| Last Updated: | August 21, 2011 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration United States: Food and Drug Administration |
Keywords provided by Tiltan Pharma Ltd.:
|
CRPC HRPC metastatic prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013