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NCT00683475 · ClinicalTrials.gov registry record · Phase 2

A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer

A Phase 2 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 2
Development phase
138
Enrollment target

NCT00683475: Completed Phase 2 study, sponsored by Eli Lilly and Company.

NCT00683475 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 138 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00683475, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 2
Development phase
138 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer (APIC).

Primary Outcome

Defined as the median time from randomization to the earliest of: 1. Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST); 2. Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of \>=2 new lesions; 3. New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression) 4. Symptomatic progression (for part

Interventions

  • DRUG Prednisone
  • DRUG Mitoxantrone
  • BIOLOGICAL IMC-A12
  • BIOLOGICAL IMC-1121B (ramucirumab)

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2008-08
Est. Completion 2011-09
Phase Phase 2
Eli Lilly and Company

1,341 total trials

What the finished NCT00683475 record still lists

NCT00683475 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.

NCT00683475 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00683475 about?

NCT00683475 is a clinical study titled "A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer". The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer (APIC).

What is the current status of trial NCT00683475?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2008-08. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00683475?

The interventions under investigation include: Prednisone (DRUG), Mitoxantrone (DRUG), IMC-A12 (BIOLOGICAL), IMC-1121B (ramucirumab) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00683475?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00683475's enrollment target sits among peer trials

138 525th of 2000 higher than 1,474 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00683475, the US trial registry maintained by the National Library of Medicine. NCT00683475 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.