Phase IIB Clinical Trial of Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC) (TLH-202)

Tiltan Pharma

Status and phase: Unknown; Phase 2

Conditions: Metastatic Castration Resistant Prostate Cancer (CRPC)

Treatments: Drug: Hamsa-1™ TL-118

Study type: Interventional

Funder types: Industry

Identifiers

NCT00684970

TLH-202

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Hamsa-1™ TL-118

Other group

Description:

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

Treatment:

Drug: Hamsa-1™ TL-118