Trial · NCT03267940
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, Phase 1, Terminated, Halozyme Therapeutics; results first posted 2020-02-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 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. Trials, record NCT03267940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03267940
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT03267940
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 85 participants, actual
- Lead sponsor
- Halozyme Therapeutics
- Conditions
- Cholangiocarcinoma Non-resectable, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Gallbladder Adenocarcinoma
- Interventions
- PEGPH20, CIS, GEM, Atezolizumab
- First posted
- 2017-08-31
- Last updated
- 2020-02-07
- Results first posted
- 2020-02-07
- Limitations and caveats
- The study was terminated prematurely by the Sponsor due to stopping the clinical development of PEGPH20 in all indications based on negative pivotal data in metastatic pancreatic cancer.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Run-in Portion: Number of Participants With Adverse Events (AEs) | From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days) | 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/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. |
| Primary | Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry) | From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days) | Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, white blood cell \[WBC\] count, neutrophils \[ANC\], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen \[BUN\], albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], electrolytes \[including sodium, potassium, calcium, magnesium, chloride, and bicarbonate\], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. |
| Primary | Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs | From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days) | Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. |
| Primary | Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication | From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days) | Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. 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. 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/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. |
| Primary | Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response | 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) | ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response | 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: 508 days) | ORR was defined as percentage of participants who achieved either a CR or PR. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1 | From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days) | DOR was considered the time from date of the first CR or PR until the date of first documentation of disease progression or date of death based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. |
| Secondary | Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1 | From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days) | PFS was based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review and was defined as the time from randomization to radiological disease progression or death. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on or prior to the current assessment (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of greater than or equal to (≥) 5 mm. |
| Secondary | Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD) | From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days) | DCR was defined as the percentage of participants with CR, PR, or SD based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. |
| Secondary | Expansion Portion: Overall Survival (OS) | From randomization until death from any cause (maximum exposure: 421 days) | Overall survival was defined as the time from randomization until death from any cause. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Run-in Portion: Number of Participants With Adverse Events (AEs) | From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days) | Safety population included all participants who received any study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry) | From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days) | Safety population included all participants who received any study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs | From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| PRIMARY | Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication | From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days) | Safety population included all participants who received any study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response | 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) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response | 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: 508 days) | Data for this outcome measure was not Collected due to early termination of study. | ||
| SECONDARY | Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1 | From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1 | From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD) | From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Expansion Portion: Overall Survival (OS) | From randomization until death from any cause (maximum exposure: 421 days) | This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Run-in Portion: Number of Participants With Adverse Events (AEs) | Run-in Portion: PEGCISGEM | 9 | Participants | ||
| Run-in Portion: Number of Participants With Adverse Events (AEs) | Run-in Portion: PEGCISGEMATEZO | 9 | Participants | ||
| Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry) | Run-in Portion: PEGCISGEM | 0 | Participants | ||
| Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry) | Run-in Portion: PEGCISGEMATEZO | 0 | Participants | ||
| Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication | Run-in Portion: PEGCISGEM | 6 | Participants | ||
| Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication | Run-in Portion: PEGCISGEMATEZO | 7 | Participants | ||
| Expansion Portion: Number of Participants With AEs | Expansion Portion: PEGCISGEM | 24 | Participants | ||
| Expansion Portion: Number of Participants With AEs | Expansion Portion: PEGCISGEMATEZO Twice Weekly | 22 | Participants | ||
| Expansion Portion: Number of Participants With AEs | Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly | 10 | Participants | ||
| Expansion Portion: Number of Participants With AEs | Expansion Portion: CISGEM | 10 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Portion (Max. Exposure: 508 Days) | STARTED | Run-in Portion: PEGCISGEM | 9 | |
| Run-in Portion (Max. Exposure: 508 Days) | STARTED | Run-in Portion: PEGCISGEMATEZO | 9 | |
| Run-in Portion (Max. Exposure: 508 Days) | STARTED | Expansion Portion: PEGCISGEM | 0 | |
| Run-in Portion (Max. Exposure: 508 Days) | STARTED | Expansion Portion: PEGCISGEMATEZO Twice Weekly | 0 | |
| Run-in Portion (Max. Exposure: 508 Days) | STARTED | Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly | 0 | |
| Run-in Portion (Max. Exposure: 508 Days) | STARTED | Expansion Portion: CISGEM | 0 | |
| Run-in Portion (Max. Exposure: 508 Days) | Received at Least 1 Dose of Study Drug | Run-in Portion: PEGCISGEM | 9 | |
| Run-in Portion (Max. Exposure: 508 Days) | Received at Least 1 Dose of Study Drug | Run-in Portion: PEGCISGEMATEZO | 9 | |
| Run-in Portion (Max. Exposure: 508 Days) | Received at Least 1 Dose of Study Drug | Expansion Portion: PEGCISGEM | 0 | |
| Run-in Portion (Max. Exposure: 508 Days) | Received at Least 1 Dose of Study Drug | Expansion Portion: PEGCISGEMATEZO Twice Weekly | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events1,740
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Run-in Portion: PEGCISGEM | 4 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Run-in Portion: PEGCISGEMATEZO | 6 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Portion: PEGCISGEM | 12 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Portion: PEGCISGEMATEZO Twice Weekly | 15 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly | 3 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Portion: CISGEM | 8 | 10 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Run-in Portion: PEGCISGEM | 0 | 9 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Run-in Portion: PEGCISGEMATEZO | 0 | 9 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Expansion Portion: PEGCISGEM | 1 | 24 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Expansion Portion: PEGCISGEMATEZO Twice Weekly | 0 | 22 |
1 to 10 of 1,740Source ClinicalTrials.gov
See all 1,740 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-in Portion: PEGCISGEM | 7 | 9 |
| Total, all-cause mortality | Run-in Portion: PEGCISGEMATEZO | 3 | 9 |
| Total, all-cause mortality | Expansion Portion: PEGCISGEM | 10 | 24 |
| Total, all-cause mortality | Expansion Portion: PEGCISGEMATEZO Twice Weekly | 13 | 22 |
| Total, all-cause mortality | Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly | 0 | 11 |
| Total, all-cause mortality | Expansion Portion: CISGEM | 6 | 10 |
| Total, other adverse events | Run-in Portion: PEGCISGEM | 9 | 9 |
| Total, other adverse events | Run-in Portion: PEGCISGEMATEZO | 9 | 9 |
| Total, other adverse events | Expansion Portion: PEGCISGEM | 24 | 24 |
| Total, other adverse events | Expansion Portion: PEGCISGEMATEZO Twice Weekly | 22 | 22 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Run-in Portion: PEGCISGEM vs Run-in Portion: PEGCISGEMATEZO: Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry) | Trial comparisons |
| Run-in Portion: PEGCISGEM vs Run-in Portion: PEGCISGEMATEZO: Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication | Trial comparisons |
| Run-in Portion: PEGCISGEM vs Run-in Portion: PEGCISGEMATEZO: Run-in Portion: Number of Participants With Adverse Events (AEs) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03267940
GET https://conductscience.org/api/trials/v1/NCT03267940/registered?page=2