An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors

Astellas

Status and phase: Completed; Phase 2; Phase 1

Conditions: Tumors; Prostate Cancer

Treatments: Drug: YM 155; Drug: Prednisone; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00514267

155-CL-025

Details and patient eligibility

About

To determine the feasibility and safety of administering YM155 in combination with docetaxel

Full description

This clinical trial is designed to include two parts:

Part 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) [ ENROLLMENT COMPLETED ]

Part 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).

This registration has been updated to reflect the design requirements of PART 2.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Part 1:

• Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.

Part 2:

• Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).

Exclusion criteria

• Radiation therapy within 4 weeks of the start of study drug

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

1. HRPC

Experimental group

Treatment:

Drug: Docetaxel

Drug: Prednisone

Drug: YM 155

2. Solid Tumors

Experimental group

Treatment:

Drug: Docetaxel

Drug: YM 155