Trial | NCT00684970  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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 Started
Mar 31
2009
Primary Completion
Feb 28
2014
Anticipated
Last Update
Dec 05
2013
Estimate

Drug Hamsa-1™ TL-118

Once daily Hamsa-1™ TL-118

Hamsa-1™ TL-118 Other

Once daily Hamsa-1™ TL-118 (single arm)

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
No Results Posted