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Alkylating agents

Combination Chemotherapy for Pancreatic Cancer

N/A

Waitlist Available

Led By Kenneth Yu, MD, MSc

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky Performance Status ≥70%

Histologically confirmed locally advanced unresectable (Stage III) or Stage IV PDAC

Must not have

History of transient ischemic attack (TIA) or cerebrovascular accident (CVA)

Patients with any prior history of arterial thrombosis or symptomatic pulmonary embolism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing PEGPH20 to see if it can help treat pancreatic cancer by breaking down a substance that contributes to tumor growth.

Who is the study for?

This trial is for adults with advanced pancreatic adenocarcinoma who haven't had certain treatments. They must be in good physical condition, not pregnant or breastfeeding, and willing to use effective contraception. People with serious heart disease, recent strokes, other cancers within 3 years (except some skin cancers and cervical carcinoma), or those at high risk of bleeding can't join.

What is being tested?

The study tests PEGPH20's effects on pancreatic cancer by breaking down hyaluronan in tumors. It's given alongside Gemcitabine and Nab-paclitaxel—common chemotherapy drugs—to see if it helps shrink the cancer more effectively than standard treatment alone.

What are the potential side effects?

PEGPH20 may cause side effects like allergic reactions due to its enzyme nature. Common chemo side effects include nausea, fatigue, hair loss, increased infection risk due to low blood counts, and potential bleeding issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform normal activities.

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My pancreatic cancer is at an advanced stage and cannot be surgically removed.

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I am 18 years old or older.

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My kidney function is normal or only slightly impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stroke or a mini-stroke in the past.

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I have had a blood clot in an artery or symptoms of a lung clot before.

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I do not have an active infection with HIV, hepatitis B, or hepatitis C.

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I have been diagnosed with significant carotid artery disease.

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I do not have an active infection needing treatment.

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I have a high risk of bleeding.

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I have severe heart disease or had a heart attack in the last year.

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My cancer has spread to my brain.

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I am not pregnant or breastfeeding.

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I have not used megestrol acetate in the last 10 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

rate of symptomatic TE events

Side effects data

From 2015 Phase 1 & 2 trial • 28 Patients • NCT01453153

75%

Thrombocytopenia

75%

Oedema peripheral

75%

Muscle spasms

75%

Dysgeusia

50%

Pyrexia

50%

Abdominal distension

50%

Abdominal pain upper

50%

Nausea

50%

Vomiting

50%

Fatigue

50%

Muscle atrophy

50%

Myalgia

50%

Pain in extremity

50%

Deep vein thrombosis

25%

Thirst

25%

Cerebrovascular accident

25%

Pulmonary embolism

25%

Anaemia

25%

Splenic infarction

25%

Tachycardia

25%

Ear discomfort

25%

Vision blurred

25%

Abdominal pain

25%

Dry mouth

25%

Asthenia

25%

Chest discomfort

25%

Oral candidiasis

25%

Pneumonia

25%

Fall

25%

Infusion related reaction

25%

Eastern Cooperative Oncology Group performance status worsened

25%

Weight decreased

25%

Dehydration

25%

Hyperglycaemia

25%

Hypoalbuminaemia

25%

Hypokalaemia

25%

Arthralgia

25%

Back pain

25%

Intervertebral disc degeneration

25%

Muscular weakness

25%

Musculoskeletal pain

25%

Headache

25%

Insomnia

25%

Mental status changes

25%

Atelectasis

25%

Dyspnoea

25%

Hiccups

25%

Decubitus ulcer

25%

Night sweats

25%

Rash pruritic

25%

Jugular vein thrombosis

25%

Venous thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

PEGPH20 1.0 μg/kg

PEGPH20 1.6 μg/kg

PEGPH20 3.0 μg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients without a prior thromboembolic event (TE)Experimental Treatment3 Interventions

Patients without a prior TE will be treated with prophylactic dose and schedule of rivaroxaban (10 mg QD), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20.

Group II: Patients with a prior thromboembolic event (TE)Experimental Treatment3 Interventions

Patients with a prior TE will be treated with therapeutic dose and schedule of rivaroxaban (15 mg BID for 21 days for induction if indicated, then 20 mg QD for chronic treatment), together with standard dose and schedule of gemcitabine, nab-paclitaxel and PEGPH20.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PEGPH20

2014

Completed Phase 2

~880

Gemcitabine

2017

Completed Phase 3

~1920