Trial · NCT02715804
A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
NCT02715804, Phase 3, Terminated, Halozyme Therapeutics; results first posted 2020-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma. Trials, record NCT02715804. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02715804
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
- NCT number
- NCT02715804
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 492 participants, actual
- Lead sponsor
- Halozyme Therapeutics
- Conditions
- Pancreatic Ductal Carcinoma
- Interventions
- Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20), Placebo, nab-Paclitaxel, Gemcitabine
- First posted
- 2016-03-22
- Last updated
- 2020-07-14
- Other registries' IDs
- eudract:2015-004068-13
- Results first posted
- 2020-07-14
- Limitations and caveats
- Due to the negative study outcome, development of PEGPH20 was terminated.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | Overall survival was defined as the time from randomization until death from any cause. Overall survival was analyzed using Kaplan-Meier methods. |
| Secondary | Progression-Free Survival (PFS) | From the date of randomization until disease progression or death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | PFS was defined as the time from randomization until the first occurrence of radiological disease progression, as determined by the blinded Central Imaging Vendor (CIV) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or death from any cause during the treatment period. Disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier method. |
| Secondary | Objective Response Rate (ORR): Percentage of Participants With Objective Response | From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) as determined by the blinded CIV based on RECIST version 1.1. 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 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 | Duration of Response (DOR) | From date of first objective response (CR or PR) until date of first disease progression (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | DOR was defined as the time from the first objective response of CR or PR until disease progression (as determined by the blinded CIV based on RECIST version 1.1) or death within 14 days of last dose of study treatment or randomization. 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. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study thus far, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. DOR was analyzed using Kaplan-Meier methods. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) | From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent AEs were defined as AEs that begin or worsen in severity during or after the participant's first dose of study treatment and no later than 30 days after the date of the last dose of study treatment and/or any treatment-related AE regardless of the onset date. 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'. |
| Secondary | Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study | From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | Severity grade associated with a laboratory parameter value was determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening. Grade 0 indicates evaluable lab records but not fall into any CTCAE grade for certain CTCAE term. A worst post-baseline grade shift was defined as the worst change that occurred at any measured timepoint during study. Hematology abnormalities: anemia(hemoglobin decreased), lymphocyte count decreased, lymphocyte count increased, neutropenia(neutrophil count decreased), thrombocytopenia(platelet count decreased), and leukopenia(white blood cell decreased). Chemistry abnormalities: hypoalbuminemia, alkaline phosphatase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hyperbilirubinemia, hypo- and hypercalcemia, creatinine increased, hypo- and hyperglycaemia, hypo- and hyperkalemia, hypo- and hypermagnesemia, hypo- and hypernatremia. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | ECGs including clinical significance was evaluated by the Investigator. Criteria for clinical significance were as per investigator's discretion. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | Vital signs included measurement of blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]), heart rate, and body weight. Criteria for clinical significance abnormalities were: Heart rate: \<50 beats per minute (bpm), \>120 bpm, \>=30 bpm increase from baseline, \>=30 bpm decrease from baseline. SBP: \>140 millimeters of mercury (mmHg) and increase from baseline \>20 mmHg, \>180 mmHg, \<90 mmHg and decrease from baseline \>10 mmHg. DBP: \>90 mmHg and increase from baseline \>20 mmHg, \>105 mmHg, \<60 mmHg and decrease from baseline \>10 mmHg. Change in weight: \>=5% increase from baseline, \>=5% decrease from baseline. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | From the date of randomization until disease progression or death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR): Percentage of Participants With Objective Response | From the date of randomization until CR or PR (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From date of first objective response (CR or PR) until date of first disease progression (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | ITT population included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants with objective response. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) | From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | Safety population included all participants who received at least 1 dose of study medication, and analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Worst Post-Baseline Hematology and Chemistry (Clinical Laboratory Parameters) Severity Grade During the Study | From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | Safety population included all participants who received at least 1 dose of study medication, and analyzed according to the treatment they actually received. Here, 'Number analyzed' signifies participants evaluable for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | Safety population included all participants who received at least 1 dose of study medication, and analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG) | Safety population included all participants who received at least 1 dose of study medication, and analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group256
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 11.2 | 95% Confidence Interval 10.3 to 12.3 | months | |
| Overall Survival | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 11.5 | 95% Confidence Interval 9.0 to 12.5 | months | |
| Progression-Free Survival (PFS) | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 7.1 | 95% Confidence Interval 5.5 to 7.4 | months | |
| Progression-Free Survival (PFS) | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 7.1 | 95% Confidence Interval 4.8 to 8.3 | months | |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 47.1 | 95% Confidence Interval 41.6 to 52.7 | percentage of participants | |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 36.4 | 95% Confidence Interval 29.0 to 44.2 | percentage of participants | |
| Duration of Response (DOR) | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 6.1 | 95% Confidence Interval 5.5 to 7.8 | months | |
| Duration of Response (DOR) | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 7.4 | 95% Confidence Interval 5.3 to 9.4 | months | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 325 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 156 | Participants |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 327 | |
| Overall Study | STARTED | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 165 | |
| Overall Study | Received at Least 1 Dose of Study Drug | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 323 | |
| Overall Study | Received at Least 1 Dose of Study Drug | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 158 | |
| Overall Study | Safety Population | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 325 | |
| Overall Study | Safety Population | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 156 | |
| Overall Study | COMPLETED | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 98 | |
| Overall Study | COMPLETED | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 52 | |
| Overall Study | NOT COMPLETED | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 229 | |
| Overall Study | NOT COMPLETED | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 113 |
Source ClinicalTrials.gov
Adverse events570
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 | Oedema peripheral | General disorders | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 198 | 325 | |
| other | Oedema peripheral | General disorders | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 52 | 156 | |
| other | Fatigue | General disorders | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 162 | 325 | |
| other | Fatigue | General disorders | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 70 | 156 | |
| other | Pyrexia | General disorders | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 94 | 325 | |
| other | Pyrexia | General disorders | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 49 | 156 | |
| other | Asthenia | General disorders | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 74 | 325 | |
| other | Asthenia | General disorders | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 36 | 156 | |
| other | Chills | General disorders | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 25 | 325 | |
| other | Chills | General disorders | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 10 | 156 |
1 to 10 of 570Source ClinicalTrials.gov
See all 570 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 222 | 325 |
| Total, all-cause mortality | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 106 | 156 |
| Total, other adverse events | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 198 | 325 |
| Total, other adverse events | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 73 | 156 |
| Total, serious adverse events | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | 187 | 325 |
| Total, serious adverse events | AG: Placebo + Nab-Paclitaxel + Gemcitabine | 80 | 156 |
Source ClinicalTrials.gov
Papers0
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine vs AG: Placebo + Nab-Paclitaxel + Gemcitabine: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | Trial comparisons |
| PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine vs AG: Placebo + Nab-Paclitaxel + Gemcitabine: Number of Participants With Treatment-Emergent Adverse Events (AEs) | Trial comparisons |
| PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine vs AG: Placebo + Nab-Paclitaxel + Gemcitabine: deaths from any cause | Trial comparisons |
| PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine vs AG: Placebo + Nab-Paclitaxel + Gemcitabine: serious adverse events | 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/NCT02715804
GET https://conductscience.org/api/trials/v1/NCT02715804/results?page=2