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

Astellas Pharma Inc32 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer Tumors

Interventions

YM 155DRUG

DocetaxelDRUG

PrednisoneDRUG

Oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)

Time frame: 2 cycles

Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)

Time frame: 1 cycle

Secondary Outcomes

Assessment of safety and efficacy

Time frame: 10 cycles

Assessment of pharmacokinetics

Time frame: Part 1 only

Data from ClinicalTrials.gov

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