Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer - Full Text View

Sponsor:	Halozyme Therapeutics
Information provided by (Responsible Party):	Halozyme Therapeutics
ClinicalTrials.gov Identifier:	NCT01453153

Purpose

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.

Condition	Intervention	Phase
Stage IV Pancreatic Cancer	Drug: Gemcitabine Drug: PEGPH20+ gemcitabine	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 1b/2 Multicenter, International, Randomized, Double Blind, Placebo-Controlled, Study of Gemcitabine Combined With PEGPH20 Compared to Gemcitabine Combined With Placebo in Patients With Stage IV Previously Untreated Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:

To determine the safe dose of PEGPH20 in combination with the approved dose of gemcitabine. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The safety and tolerability profile of PEGPH20 used in combination with gemcitabine will be assessed.
To compare the effect of overall survival between treatment groups. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients.

Estimated Enrollment:	147
Study Start Date:	September 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Gemcitabine Gemcitabine + Placebo	Drug: Gemcitabine 1000 mg/m2 given IV one time a week (Cycle 1: 7 weeks on treatment, 1 week off treatment; Cycle 2+: 3 Weeks on treatment, 1 week off treatment) Other Name: Gemzar
Experimental: PEGPH20 PEGPH20+Gemcitabine	Drug: PEGPH20+ gemcitabine (Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment). Doses start at 1.0 mcg/kg and modified until recommended Phase 2 dose is determined. Gemcitabine given at 1000mg/m2. Treatment continues until patient no longer receives clinical benefit or until treatment related toxicity. Other Name: PEGylated Recombinant Human Hyaluronidase

Arms

Assigned Interventions

Active Comparator: Gemcitabine

Gemcitabine + Placebo

Drug: Gemcitabine

1000 mg/m2 given IV one time a week (Cycle 1: 7 weeks on treatment, 1 week off treatment; Cycle 2+: 3 Weeks on treatment, 1 week off treatment)

Other Name: Gemzar

Experimental: PEGPH20

PEGPH20+Gemcitabine

Drug: PEGPH20+ gemcitabine

(Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment). Doses start at 1.0 mcg/kg and modified until recommended Phase 2 dose is determined. Gemcitabine given at 1000mg/m2. Treatment continues until patient no longer receives clinical benefit or until treatment related toxicity.

Other Name: PEGylated Recombinant Human Hyaluronidase

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Patients with histologically confirmed Stage IV adenocarcinoma of the pancreas previously untreated for metastatic disease
One or more metastatic tumors measurable on CT scan per RECIST 1.1 criteria
Baseline CA19-9 of ≥ 100 U/mL in the absence of biliary obstruction or other physiological process unrelated to the tumor that may cause an elevation in CA19-9 levels
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, or cardiac arrhythmia requiring medical therapy
Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
Known allergy to hyaluronidase
Women currently pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453153

Locations

United States, New York
NSLIJ Health System, Monter Cancer Center	Recruiting
New Hyde Park, New York, United States, 11040
Contact: Marjorie Fricano, R.N.,MSN, OCN 516-734-8942
Principal Investigator: Craig Devoe, MD
Mount Sinai School of Medicine	Recruiting
New York, New York, United States, 10029
Contact: Kiev Gimpel-Tetra, R.N. 212-824-7117 kiev.gimpel-tetra@mssm.edu
Contact: Randall Holcombe, M.D. 212-659-5420
Principal Investigator: Randall Holcombe, M.D.
United States, Washington
Seattle Cancer Care Alliance	Recruiting
Seattle, Washington, United States, 90108
Contact: Audrey Mollerup 206-288-2056
Principal Investigator: Sunil Hingorani, MD
Principal Investigator: William Harris, MD
Russian Federation
Chelyabinsk Regional Clinical Oncology Center	Recruiting
Chelyabinsk, Russian Federation
Contact: Svetlana Markova +7 912 899 46 20 sveta_o.markova@mail.ru
Principal Investigator: Oleg Gladkov, M.D.
Russian Oncological Research Center n.a. N.N. Blokhin	Recruiting
Moscow, Russian Federation
Contact: Natalia Yakovleva +7 926 212 31 74 nat695@yandex.ru
Principal Investigator: Sergey Tjulandin, M.D.
Medical Radiological Research Center	Recruiting
Obninsk, Russian Federation
Contact: Yury Petrov, M.D. 7 910 914 16 55 petrovdoc@mail.ru
Principal Investigator: Boris Berdov, M.D.

Sponsors and Collaborators

Halozyme Therapeutics

Investigators

Study Director:

Joy H Zhu, MD, PhD

Halozyme, Inc.

More Information

No publications provided

Responsible Party:	Halozyme Therapeutics
ClinicalTrials.gov Identifier:	NCT01453153 History of Changes
Other Study ID Numbers:	Halo-109-201
Study First Received:	October 13, 2011
Last Updated:	March 22, 2012
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee Russia: Ministry of Health and Social Development of the Russian Federation Romania: Ethics Committee Romania: National Medicines Agency Hungary: Scientific and Medical Research Council Ethics Committee Hungary: National Institute of Pharmacy Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control

Keywords provided by Halozyme Therapeutics:

pancreatic
Cancer
Stage IV
untreated

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 23, 2012