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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

NCT03267940 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2020-02-07

Study results available
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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).

Conditions

  • Cholangiocarcinoma Non-resectable
  • Cholangiocarcinoma, Intrahepatic
  • Cholangiocarcinoma, Extrahepatic
  • Gallbladder Adenocarcinoma

Interventions

DRUG

PEGPH20

PEGPH20 will be administered as per the schedule specified in the respective arms.

DRUG

CIS

CIS will be administered as per the schedule specified in the respective arms.

DRUG

GEM

GEM will be administered as per the schedule specified in the respective arms.

DRUG

Atezolizumab

Atezolizumab will be administered as per the schedule specified in the respective arms.

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • VP, Medical, Regulatory and Drug Safety · Halozyme Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2019-11-11
Completion
2019-11-11
FDA Drug
Yes

Countries

  • United States
  • South Korea
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03267940 on ClinicalTrials.gov