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NCT03781362 · ClinicalTrials.gov registry record · Phase 1

Study of CPI-100 in Patients With Advanced Tumors

A Phase 1 study, sponsored by Coordination Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT03781362: Completed Phase 1 study, sponsored by Coordination Pharmaceuticals.

NCT03781362 is a Phase 1 study that has completed, run by Coordination Pharmaceuticals. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03781362, a Phase 1 study, has completed, sponsored by Coordination Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

This is a prospective, open-label, 2-arm, non-randomized study of CPI-100 in patients with advanced tumors. CPI-100 is administered via intravenous infusion in a 3 + 3 study design to identify the maximum tolerated dose (MTD).

Primary Outcome

• To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy as assessed by CTCAE5

Interventions

  • DRUG Capecitabine
  • DRUG CPI-100

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2018-12-21
Est. Completion 2022-06-21
Phase Phase 1
Coordination Pharmaceuticals

6 total trials

What the finished NCT03781362 record still lists

NCT03781362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.

NCT03781362 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03781362 about?

NCT03781362 is a clinical study titled "Study of CPI-100 in Patients With Advanced Tumors". This is a prospective, open-label, 2-arm, non-randomized study of CPI-100 in patients with advanced tumors. CPI-100 is administered via intravenous infusion in a 3 + 3 study design to identify the maximum tolerated dose (MTD).

What is the current status of trial NCT03781362?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-12-21. Estimated completion is 2022-06-21.

What interventions are being tested in trial NCT03781362?

The interventions under investigation include: Capecitabine (DRUG), CPI-100 (DRUG).

Who is sponsoring clinical trial NCT03781362?

This trial is sponsored by Coordination Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03781362's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT03781362, the US trial registry maintained by the National Library of Medicine. NCT03781362 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.