Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer

Halozyme

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stage IV Pancreatic Cancer

Treatments: Drug: PEGPH20; Drug: Gemcitabine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01453153

Halo-109-201

Details and patient eligibility

About

Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of PEGPH20 to use in combination with gemcitabine in Stage IV previously untreated pancreatic cancer patients.

Phase 2: Randomized, double blind study to compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients.

Full description

PEGPH20 is a PEGylated version of human recombinant PH20 hyaluronidase that, in preclinical studies, has been shown to remove HA from the extracellular matrix surrounding tumor cells by depolymerizing this substrate. 87% of pancreatic ductal adenocarcinomas (PDA) overexpress HA. PDA tumor tissue may be especially sensitive to the HA-degradation properties of PEGPH20 and thus more responsive to the cytotoxic effects of a given dose of gemcitabine. Modifying the extracellular environment to increase the penetration and efficacy of anti-cancer agents represents a novel approach to treating pancreatic cancer and may provide important therapeutic outcomes in patients with Stage IV Previously Untreated Pancreatic Cancer.

This Phase 1B/2 study will assess safety, tolerability, treatment effect, and various PK/PD endpoints.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Patients with histologically confirmed Stage IV adenocarcinoma of the pancrease previously untreated for metastatic disease
• One or more metastatic tumors measurable on CT scan per RECIST 1.1 criteria
• Life expectancy of at least 3 months
• Signed, written IRB/EC-approved informed consent
• A negative serum pregnancy test, if female

Key Exclusion Criteria:

• Known brain metastasis
• New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 12 months
• Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
• Known allergy to hyaluronidase
• Women currently pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Gemcitabine

Active Comparator group

Description:

Gemcitabine + Placebo

Treatment:

Drug: Placebo

Drug: Gemcitabine

PEGPH20

Experimental group

Description:

PEGPH20+Gemcitabine

Treatment:

Drug: Gemcitabine

Drug: PEGPH20