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NCT02168725 · ClinicalTrials.gov registry record · Phase 1

Dose-escalation, Safety and Pharmacokinetic Study of Briciclib in Advanced Solid Tumors

A Phase 1 study, sponsored by Traws Pharma.

Terminated
Registry status
Phase 1
Development phase
26
Enrollment target

NCT02168725: Clinical Trial Phase 1 study, sponsored by Traws Pharma.

NCT02168725 is a Phase 1 study that was terminated before completion, run by Traws Pharma. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02168725, a Phase 1 study, was terminated before completion, sponsored by Traws Pharma.

TERMINATED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

The main objectives of this study are to determine the safety profile of briciclib, an experimental anti-cancer drug, as it is administered intravenously once weekly as escalating doses in adult patients with advanced cancer and solid tumors, and to determine the highest dose of briciclib that can be safely given. Secondary objectives are to determine how the amount of briciclib in circulation changes over time and how much briciclib gets into the urine for excretion, and to document potential anti-tumor effects of briciclib.

Primary Outcome

Adverse events will be grouped by system organ class (SOC) and preferred term (PT) using the most recent version of the Medical Dictionary for Regulatory Activities (MedDRA), and will be summarized by worst grade according to NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

Interventions

  • DRUG briciclib

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2014-06
Est. Completion 2015-12
Phase Phase 1
Traws Pharma

25 total trials

Why NCT02168725 stopped before completion

NCT02168725 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 1 intervention - of which briciclib is the first listed.

NCT02168725 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02168725 about?

NCT02168725 is a clinical study titled "Dose-escalation, Safety and Pharmacokinetic Study of Briciclib in Advanced Solid Tumors". The main objectives of this study are to determine the safety profile of briciclib, an experimental anti-cancer drug, as it is administered intravenously once weekly as escalating doses in adult patients with advanced cancer and solid tumors, and to determine the highest dose of briciclib that can b...

What is the current status of trial NCT02168725?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2014-06. Estimated completion is 2015-12.

What interventions are being tested in trial NCT02168725?

The interventions under investigation include: briciclib (DRUG).

Who is sponsoring clinical trial NCT02168725?

This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02168725's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 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 NCT02168725, the US trial registry maintained by the National Library of Medicine. NCT02168725 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.