Pancreatic Cancer Research

Clinical trialPhase 3Terminated

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

NCT02715804↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Stopped earlySponsor decision (Business decision)
Phase
Phase 3
Status
Terminated
Study type
Interventional
Start
14 March 2016
Expected end
4 November 2019
Enrollment
492 participants
Sites
217
Primary outcomes
Overall Survival
Sponsor
Industry
Results posted
2020-07-14
Last update
14 July 2020

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Brief summary public domain (ClinicalTrials.gov)

The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).

Detailed description public domain (ClinicalTrials.gov)

Participants will be randomized in a 2:1 ratio to PAG or AG treatment.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival [From randomization until death from any cause (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)]. Median, months (95% Confidence Interval). PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=327): 11.2 (10.3 to 12.3); AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=165): 11.5 (9.0 to 12.5).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Median, months (95% Confidence Interval). PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=327): 7.1 (5.5 to 7.4); AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=165): 7.1 (4.8 to 8.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Number, percentage of participants (95% Confidence Interval). PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=327): 47.1 (41.6 to 52.7); AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=165): 36.4 (29.0 to 44.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Median, months (95% Confidence Interval). PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=154): 6.1 (5.5 to 7.8); AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=60): 7.4 (5.3 to 9.4).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Count Of Participants, Participants. PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 325; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 156.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Count Of Participants, Participants. Anemia: Post-baseline / Grade 0: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 6; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 3. Anemia: Post-baseline / Grade 1: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 84; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 41. Anemia: Post-baseline / Grade 2: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 164; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 74. Anemia: Post-baseline / Grade 3: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 67; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 37. Anemia: Post-baseline / Grade 4: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 0; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 0. Lymphocyte count decreased: Post-baseline / Grade 0: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 33; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 17. Lymphocyte count decreased: Post-baseline / Grade 1: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 83; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 46. Lymphocyte count decreased: Post-baseline / Grade 2: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 102; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 46. Lymphocyte count decreased: Post-baseline / Grade 3: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 90; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 40. Lymphocyte count decreased: Post-baseline / Grade 4: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 13; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 6. Lymphocyte count increased: Post-baseline / Grade 0: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 302; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 150. Lymphocyte count increased: Post-baseline / Grade 1: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 0; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 0. Lymphocyte count increased: Post-baseline / Grade 2: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 19; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 5. Lymphocyte count increased: Post-baseline / Grade 3: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 0; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 0. Lymphocyte count increased: Post-baseline / Grade 4: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 0; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 0. Neutropenia: Post-baseline / Grade 0: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 85; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 31. Neutropenia: Post-baseline / Grade 1: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 27; AG: Placebo + Nab-Paclitaxel + Gemcitab

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Count Of Participants, Participants. PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 8; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 4.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)]. Count Of Participants, Participants. Heart rate: <50 bpm: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 7; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 4. Heart rate: >120 bpm: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 47; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 13. Heart rate: >=30 bpm increase from baseline: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 102; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 26. Heart rate: >=30 bpm decrease from baseline: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 38; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 19. SBP: >140 mmHg and increase from baseline >20 mmHg: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 75; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 37. SBP: >180 mmHg: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 6; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 4. SBP: <90 mmHg and decrease from baseline >10 mmHg: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 60; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 17. DBP: >90 mmHg and increase from baseline >20 mmHg: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 21; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 10. DBP: >105 mmHg: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 8; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 6. DBP: <60 mmHg and decrease from baseline >10 mmHg: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 142; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 56. Change in weight: >=5% increase from baseline: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 85; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 52. Change in weight: >=5% decrease from baseline: PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine (n=325): 151; AG: Placebo + Nab-Paclitaxel + Gemcitabine (n=156): 57.

Papers 1

The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.