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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00514267

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Tumors	Drug: YM 155 Drug: Docetaxel Drug: Prednisone	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. HRPC	Drug: YM 155 IV Drug: Docetaxel IV Drug: Prednisone Oral
Experimental: 2. Solid Tumors	Drug: YM 155 IV Drug: Docetaxel IV

Arm

Intervention/Treatment

Experimental: 1. HRPC

Drug: YM 155

Drug: Docetaxel

Drug: Prednisone

Oral

Experimental: 2. Solid Tumors

Drug: YM 155

Drug: Docetaxel

Outcome Measures

Primary Outcome Measures

Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC) [2 cycles]
Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors) [1 cycle]

Secondary Outcome Measures

Assessment of safety and efficacy [10 cycles]
Assessment of pharmacokinetics [Part 1 only]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.