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

Study Overview
=================
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.

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

Conditions
-----------------
Metastatic Castration Resistant Prostate Cancer (CRPC)

Intervention / Treatment
-----------------
* Drug: Hamsa-1™ TL-118


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hamsa-1™ TL-118<br>Once daily Hamsa-1™ TL-118 (single arm) | Drug: Hamsa-1™ TL-118<br>* Once daily Hamsa-1™ TL-118<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRPC, HRPC, metastatic prostate cancer