Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Metastatic Castration Resistant Prostate Cancer (CRPC)

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS) measured 24 weeks after treatment initiation

Outcome Time Frame:

24 weeks and up to 3 years

Safety Issue:

No

Principal Investigator

Dan Goldstaub, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Chief Operating Officer, Tiltan Pharma LtD

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

TLH-202

NCT ID:

NCT00684970

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Metastatic Castration Resistant Prostate Cancer (CRPC)
  • CRPC
  • HRPC
  • metastatic prostate cancer
  • Prostatic Neoplasms

Name

Location