TerminatedPhase 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

Stopped: Sponsor decision

United States85 participantsStarted 2017-10-02

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Idiopathic pulmonary fibrosis, organizing pneumonia (for example, bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
✕. Or known cases of hepatobiliary diseases (for example, primary biliary cholangitis, primary sclerosing cholangitis, history of immune-mediated cholangitis);
✕. Or known cases of drug-induced hepatobiliary toxicities.

What they're measuring

Run-in Portion: Number of Participants With Adverse Events (AEs)

Timeframe: From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days)

Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry)

Timeframe: From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)

Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs

Timeframe: From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)

Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication

Timeframe: From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)

Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response

Timeframe: From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 421 days)

Trial details

NCT IDNCT03267940

SponsorHalozyme Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-11

Results submitted2020-01-24

View on ClinicalTrials.gov More Cholangiocarcinoma Non-resectable trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Idiopathic pulmonary fibrosis, organizing pneumonia (for example, bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
✕. Or known cases of hepatobiliary diseases (for example, primary biliary cholangitis, primary sclerosing cholangitis, history of immune-mediated cholangitis);
✕. Or known cases of drug-induced hepatobiliary toxicities.