Trial Outcomes & Findings for PEGPH20, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma (NCT NCT02487277)

Last Updated: 2020-01-02

Results Overview

Our study will be investigating only clinically relevant pancreatic fistulas, i.e. grades B or C. Descriptive statistics will be used report the incidence of pancreatic fistula within the 7-day post-operative period after neoadjuvant treatment

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2020-01-02

Participant Flow

Study was terminated earlier than expected due to low accrual so no participants were enrolled in the "Combination therapy alone" treatment arm.

Participant milestones

Participant milestones
Measure	Combination Therapy With 1 Week Run-In PEGPH20: 3ug/kg on Days 1 and 4 1 cycle = 28 days PEGPH20: 3ug/kg on Days 1, 8, 15 Gemcitabine: 1000mg/m\^2 on Days 1, 8, 15 Nab-paclitaxel: 125mg/m\^2 on Days 1, 8, 15 PEGPH20 Gemcitabine Nab-paclitaxel	Combination Therapy Alone 1 cycle = 28 days PEGPH20: 3ug/kg on Days 1, 8, 15 Gemcitabine: 1000mg/m\^2 on Days 1, 8, 15 Nab-paclitaxel: 125mg/m\^2 on Days 1, 8, 15 PEGPH20 Gemcitabine Nab-paclitaxel
Overall Study STARTED	3	0
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PEGPH20, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 5 years

Population: No data was collected for these patients.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 5 years

Population: No data was collected for these patients.

Descriptive statistics with frequency / proportion will be used to evaluate rate of pathologic complete response using the pathological exam of resected tumors. pCR was defined as area of scarring in pancreatic parenchyma and/or peripancreatic soft tissue with chronic inflammation, with or without acellular mucin pools and histiocytic infiltrates, but no residual viable invasive adenocarcinoma cells in the pancreatectomy specimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No data was collected for this endpoint

To evaluate the disease response to treatment, CA19-9 levels will be measured every 4 weeks and restaging Computerized tomography (CT) / magnetic resonance imaging (MRI)of the chest, abdomen and pelvis will be obtained every 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No data was collected for these patients.

Patients will be evaluated for surgical resection depending on imaging obtained on Cycle 4 Day 21. R0 Resection rate determined by CA 19-9 levels will be checked every 4 weeks and restaging CT/MRI of the chest, abdomen and pelvis will be obtained every 8 weeks surgical resection if the patient's tumor is deemed resectable post-therapy. Patients who have received at least 2 complete, 28-day cycles of study drugs were included in the secondary analyses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No data was collected for these patients.

Descriptive statistics with frequency and proportion of overall response determined by CA 19-9 levels will be checked every 4 weeks and restaging CT/MRI of the chest, abdomen and pelvis will be obtained every 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No data was collected for these patients.

Kaplan-Meier methods will be used to analyze disease free survival and median time and 95% confidence intervals will be reported

Outcome measures

Outcome data not reported

Adverse Events

Combination Therapy With 1 Week Run-In

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Combination Therapy With 1 Week Run-In n=3 participants at risk PEGPH20: 3ug/kg on Days 1 and 4 1 cycle = 28 days PEGPH20: 3ug/kg on Days 1, 8, 15 Gemcitabine: 1000mg/m\^2 on Days 1, 8, 15 Nab-paclitaxel: 125mg/m\^2 on Days 1, 8, 15 PEGPH20 Gemcitabine Nab-paclitaxel
Cardiac disorders Myocardial infarction	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.

Other adverse events

Other adverse events
Measure	Combination Therapy With 1 Week Run-In n=3 participants at risk PEGPH20: 3ug/kg on Days 1 and 4 1 cycle = 28 days PEGPH20: 3ug/kg on Days 1, 8, 15 Gemcitabine: 1000mg/m\^2 on Days 1, 8, 15 Nab-paclitaxel: 125mg/m\^2 on Days 1, 8, 15 PEGPH20 Gemcitabine Nab-paclitaxel
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • Number of events 4 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Gastrointestinal disorders Cheilitis	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 7 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Gastrointestinal disorders Hemorrhoids	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 8 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
General disorders Edema limbs	100.0% 3/3 • Number of events 7 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
General disorders Fatigue	100.0% 3/3 • Number of events 6 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
General disorders Chills	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
General disorders Fever	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
General disorders Irritability	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
General disorders Non-cardiac chest pain	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Musculoskeletal and connective tissue disorders Myalgia	100.0% 3/3 • Number of events 9 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Musculoskeletal and connective tissue disorders Back Pain	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 2 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Musculoskeletal and connective tissue disorders Flank Pain	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 2 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Nervous system disorders Dizziness	66.7% 2/3 • Number of events 2 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Nervous system disorders Peripheral sensory neuropathy	66.7% 2/3 • Number of events 2 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Nervous system disorders Memory impairment	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 3/3 • Number of events 4 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Respiratory, thoracic and mediastinal disorders Hiccups	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Vascular disorders Hematoma	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Vascular disorders Hot flashes	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Vascular disorders Phlebitis	33.3% 1/3 • Number of events 2 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Vascular disorders Thromboembolic event	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Infections and infestations Laryngitis	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Infections and infestations Mucosal infection	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Infections and infestations Papulopustular rash	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Infections and infestations Rash pustular	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Infections and infestations Rhinitis infective	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Investigations Neutrophil count decreased	66.7% 2/3 • Number of events 5 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 3 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Investigations Alkaline phosphatase increased	33.3% 1/3 • Number of events 4 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 3 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 4 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 2 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Psychiatric disorders Insomnia	66.7% 2/3 • Number of events 2 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Psychiatric disorders Libido decreased	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Skin and subcutaneous tissue disorders Alopecia	66.7% 2/3 • Number of events 7 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	33.3% 1/3 • Number of events 5 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Ear and labyrinth disorders Hearing impaired	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.
Renal and urinary disorders Renal and urinary disorders - Other, specify	33.3% 1/3 • Number of events 1 • Investigator and the study team will record any occurrences of Adverse Events (AEs) from the signing of the informed consent to 28 days after the last dose of study drug, or longer if the PI deems the event is related to the drug - up to 5 years All eligible patients who are enrolled into the study and receive at least one complete, 28-day cycle of the study drugs will be included in the safety analysis. Enrollment was terminated early due to low accrual, with no patients enrolled in the combination therapy alone arm.

Additional Information

Dr. Andrew Ko

University of California, San Francisco

Phone: (415) 353-7286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Combination Therapy With 1 Week Run-In n=3 Participants PEGPH20: 3ug/kg on Days 1 and 4 1 cycle = 28 days PEGPH20: 3ug/kg on Days 1, 8, 15 Gemcitabine: 1000mg/m\^2 on Days 1, 8, 15 Nab-paclitaxel: 125mg/m\^2 on Days 1, 8, 15 PEGPH20 Gemcitabine Nab-paclitaxel	Combination Therapy Alone 1 cycle = 28 days PEGPH20: 3ug/kg on Days 1, 8, 15 Gemcitabine: 1000mg/m\^2 on Days 1, 8, 15 Nab-paclitaxel: 125mg/m\^2 on Days 1, 8, 15 PEGPH20 Gemcitabine Nab-paclitaxel	Total n=3 Participants Total of all reporting groups
Age, Customized 50-59 years old	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Customized 70-79 years old	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	3 participants n=5 Participants