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Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Docetaxel and Prednisone (CRPC)

NCT01234025 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2023-10-06

No results posted yet for this study

Summary

The purpose of this study is to examine the safety, tolerability and progression-free survival of patients with Castrate-Resistant Prostate Cancer treated with ISIS EIF4E Rx in combination with docetaxel and prednisone.

Conditions

  • Castrate-Resistant Prostate Cancer

Interventions

DRUG

ISIS EIF4E Rx

800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.

DRUG

ISIS EIF4E Rx

1000 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.

DRUG

ISIS EIF4E Rx

(Dose identified in Part 1)ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.

DRUG

Prednisone

5 mg administered orally twice daily on days 1, 8, 15 and 22 of each cycle

DRUG

Docetaxel

75 mg/m2 administered as a 1-hour intravenous infusion on day 1 of each cycle

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-05-31
Completion
2013-12-31
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Poland
  • Puerto Rico
  • Romania
  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01234025 on ClinicalTrials.gov