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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00514267

Enrollment

Registered

2007-08-09

Start date

2007-05-31

Completion date

2010-03-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Tumors

Keywords

Prostate Cancer, HRPC, Hormone Refractory Prostate Cancer, YM155, Treatment Outcome, Solid Tumors

Brief summary

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

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.

Interventions

DRUGYM 155

DRUGDocetaxel

DRUGPrednisone

Oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Assessment of safety and efficacy	10 cycles
Assessment of pharmacokinetics	Part 1 only

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026