Multi-Center Phase II Study to Compare MER-101 20mg Tablets to Intravenous Zometa 4mg in Male Bisphosphonate-Naive, Hormone Refractory Prostate Cancer Patients

Merrion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hormone-Refractory Prostate Cancer

Treatments: Drug: Zoledronic Acid 20mg Tablets; Drug: Zoledronic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00636740

MER-101-03

Details and patient eligibility

About

The objective of MER-101-03 is to examine the effects of two different dosing regimens of MER-101 20mg tablets versus Zometa 4mg IV infusion once-monthly therapy. The effects will be monitored on a weekly basis by measuring various markers of bone metabolism. Patients to be enrolled will be those who have not received any previous bisphosphonate therapy. The study will be carried out on prostate cancer patients who are no longer on hormone therapy. Treatment in the study will be for a 2-month period.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis based on an X-ray.

Exclusion criteria

• Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

B

Experimental group

Description:

MER-101 20mg Tablets Regimen 1

Treatment:

Drug: Zoledronic Acid 20mg Tablets

Drug: Zoledronic Acid 20mg Tablets

C

Experimental group

Description:

MER-101 20mg Tablets Regimen 2

Treatment:

Drug: Zoledronic Acid 20mg Tablets

Drug: Zoledronic Acid 20mg Tablets

A

Active Comparator group

Description:

Zometa Injection

Treatment:

Drug: Zoledronic Acid