Metastatic Castration Resistant Prostate Cancer (CRPC)Phase 2TLH-202NCT00684970
Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
A Phase 2 study testing Hamsa-1™ TL-118 in people with Metastatic Castration Resistant Prostate Cancer (CRPC), run by Tiltan Pharma Ltd. at 5 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer (CRPC)
- What is being tested?
- Hamsa-1™ TL-118
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesIsrael
- Study dates
- Mar 2009to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites, 5 recruiting
- Recruiting
Bnei Tzion Medical Center
Haifa
Prof. Ofer Nativ, ofer.nativ@b-zion.org.il
Prof. Ofer Nativ, MD
- Recruiting
Rambam Medical Center
Haifa
Avivit Peer, MD, a_peer@rambam.health.gov.il
Dr. Avivit Peer, MD
- Recruiting
Sourasky Medical Center
Tel Aviv
Dr. Eliahu Gez, MD, eliahug@tasmc.health.gov.il
Dr. Eliahu Gez, MD
- Recruiting
Sheba Medical Center
Tel HaShomer
Dr. Raanan Berger, M.D., Raanan.Berger@sheba.health.gov.il
Dr. Raanan Berger, MD, PhD
- Recruiting
Asaf Harofe Medical Center
Tzrifin
Prof. Avishay Sella, MD, Dr.AvishaySella@asaf.health.gov.il
Prof. Avishay Sella, MD
About this study
Official title: 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.
- Being tested
- Hamsa-1™ TL-118
- Keywords
- CRPC, HRPC, metastatic prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamsa-1™ TL-118Drug
Once daily Hamsa-1™ TL-118
| Study group | Role | What they receive |
|---|---|---|
| Hamsa-1™ TL-118 | Other | Once daily Hamsa-1™ TL-118 (single arm) Receives: Drug: Hamsa-1™ TL-118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) measured 24 weeks after treatment initiation
Measured: 24 weeks and up to 3 years
Secondary outcomes (2)
Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients.
Measured: 52 weeks and up to 3 years
Safety and tolerability
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startMar 2009
- Primary completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate Cancer (CRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tiltan Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Goldstaub, PhD, Study director, Chief Operating Officer, Tiltan Pharma LtD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684970
- Sponsor's protocol ID
- TLH-202
- Acronym
- TLH-202
- Status last verified
- Dec 2013
- First submitted
- 22 May 2008
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
- ClinicalTrials.gov ID
- NCT00684970
- Acronym / sponsor ID
- TLH-202 / TLH-202
- Keywords
- CRPC, HRPC, metastatic prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tiltan Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2014 (estimated)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hamsa-1™ TL-118 | Other | Drug: Hamsa-1™ TL-118Once daily Hamsa-1™ TL-118 (single arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamsa-1™ TL-118Once daily Hamsa-1™ TL-118 | Drug | Hamsa-1™ TL-118 |
Primary outcome
Progression free survival (PFS) measured 24 weeks after treatment initiation
Time frame: 24 weeks and up to 3 years
2 secondary outcomes
Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients.
Time frame: 52 weeks and up to 3 years
Safety and tolerability
Time frame: Throughout study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Goldstaub, PhD study director
Chief Operating Officer, Tiltan Pharma LtD
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hamsa-1™ TL-118 in people with Metastatic Castration Resistant Prostate Cancer (CRPC), run by Tiltan Pharma Ltd. at 5 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Goldstaub, Ph.D. (972-54-555-8573, dan@tiltanpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) measured 24 weeks after treatment initiation (time frame: 24 weeks and up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013.