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NCT03267940 · ClinicalTrials.gov registry record · Phase 1

Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma

A Phase 1 study, sponsored by Halozyme Therapeutics.

Terminated
Registry status
Phase 1
Development phase
85
Enrollment target

NCT03267940: Clinical Trial Phase 1 study, sponsored by Halozyme Therapeutics.

NCT03267940 is a Phase 1 study that was terminated before completion, run by Halozyme Therapeutics. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03267940, a Phase 1 study, was terminated before completion, sponsored by Halozyme Therapeutics.

TERMINATED
Registry status
Phase 1
Development phase
85 participants
Enrollment target

Study Summary

The study is being conducted to assess the safety and tolerability of (1) PEGPH20 in combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).

Primary Outcome

An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapaci

Interventions

  • DRUG Atezolizumab
  • DRUG PEGPH20
  • DRUG CIS
  • DRUG GEM

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2017-10-02
Est. Completion 2019-11-11
Phase Phase 1
Halozyme Therapeutics

31 total trials

Why NCT03267940 stopped before completion

NCT03267940 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).

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

NCT03267940 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03267940 about?

NCT03267940 is a clinical study titled "Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma". The study is being conducted to assess the safety and tolerability of (1) PEGPH20 in combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).

What is the current status of trial NCT03267940?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2017-10-02. Estimated completion is 2019-11-11.

What interventions are being tested in trial NCT03267940?

The interventions under investigation include: Atezolizumab (DRUG), PEGPH20 (DRUG), CIS (DRUG), GEM (DRUG).

Who is sponsoring clinical trial NCT03267940?

This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03267940's enrollment target sits among peer trials

85 656th of 2000 higher than 1,342 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 NCT03267940, the US trial registry maintained by the National Library of Medicine. NCT03267940 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.