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NCT00130442 · ClinicalTrials.gov registry record · Phase 2

Trial of PI-88 With Dacarbazine in Patients With Metastatic Melanoma

A Phase 2 study, sponsored by Cellxpert Biotechnology.

Completed
Registry status
Phase 2
Development phase
134
Enrollment target

NCT00130442: Completed Phase 2 study, sponsored by Cellxpert Biotechnology.

NCT00130442 is a Phase 2 study that has completed, run by Cellxpert Biotechnology. The registered enrollment target is 134 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

NCT00130442, a Phase 2 study, has completed, sponsored by Cellxpert Biotechnology.

COMPLETED
Registry status
Phase 2
Development phase
134 participants
Enrollment target

Study Summary

The aim of the study is to compare the safety and effectiveness of a new drug called PI-88, when used in combination with an approved chemotherapy drug called dacarbazine, in the treatment of metastatic melanoma. PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine stops the cancer cells from growing. The results from this study will be analysed to see if it is worthwhile for the two drugs to be tested in future studies involving larger numbers of melanoma patients.

Primary Outcome

The Proportion of Patients With Objective Response or Stable Disease (Non-progression Rate) after six treatment cycles

Interventions

  • DRUG PI-88 and dacarbazine
  • DRUG dacarbazine or DTIC

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2005-06
Est. Completion 2010-10
Phase Phase 2
Cellxpert Biotechnology

3 total trials

What the finished NCT00130442 record still lists

NCT00130442 is an interventional study that assigns participants to a tested intervention. The registered 134 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 2 interventions - of which PI-88 and dacarbazine is the first listed.

NCT00130442 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00130442 about?

NCT00130442 is a clinical study titled "Trial of PI-88 With Dacarbazine in Patients With Metastatic Melanoma". The aim of the study is to compare the safety and effectiveness of a new drug called PI-88, when used in combination with an approved chemotherapy drug called dacarbazine, in the treatment of metastatic melanoma. PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbaz...

What is the current status of trial NCT00130442?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2005-06. Estimated completion is 2010-10.

What interventions are being tested in trial NCT00130442?

The interventions under investigation include: PI-88 and dacarbazine (DRUG), dacarbazine or DTIC (DRUG).

Who is sponsoring clinical trial NCT00130442?

This trial is sponsored by Cellxpert Biotechnology, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00130442's enrollment target sits among peer trials

134 537th of 2000 higher than 1,463 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 NCT00130442, the US trial registry maintained by the National Library of Medicine. NCT00130442 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.