We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01839487
Previous Study | Return to List | Next Study

PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer (HALO-109-202)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01839487
Recruitment Status : Active, not recruiting
First Posted : April 25, 2013
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer.

The Phase 2 will study safety and treatment effect in 237 subjects (2:1 randomization, PAG:AG), preceded by two run-in phases (the first to assess safety and tolerability and a second to assess a new formulation of PEGHP20), 16 subjects total (randomized 3:1).


Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: PEGPH20+nab-paclitaxel+gemcitabine Drug: nab-paclitaxel + gemcitabine Phase 2

Detailed Description:
  1. Phase 2, multicenter open-label randomized study with two run-in phases. The first run-in phase was to evaluate safety and tolerability of PEGPH20 + Nab-paclitaxel + Gemcitabine vs. Nab-paclitaxel + Gemcitabine. A second run-in phase was to evaluate a new formulation of PEGPH20.

    Phase 2 will be an open-label randomized study with same study drugs evaluating safety and efficacy.

  2. Subjects must have newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer diagnosed by a standard of Care CT scan within 20 days of dosing and meet all inclusion/exclusion criteria.
  3. Treatment consists of 4 week treatment cycles with Week 4 of every cycle, a wash-out week. In Cycle 1, PEGPH20 will be administered twice per week with Nab-paclitaxel + Gemcitabine given once/week 2-4 hrs after PEGPH20 and nab-paclitaxel + gemcitabine alone
  4. Safety parameters include medical history, physical exams, adverse event and Concomitant med collection, Doppler and CT scans for thromboembolic events, prophylactic enoxaparin, Karnofsky Performance scale, Immunogenicity, Hematology, Chemistry, coagulation, Weight/body surface area (BSA) for dosing, ECG and pharmacokinetics (PK) and Hyaluronan (HA) catabolite levels. Efficacy parameters include standard of care CT scans, CA19-9, tumor analysis of HA.
  5. Subjects continue in study until disease progression, adverse event/toxicity, death or either the subject/sponsor discontinues the study.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase)Combined With Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer
Study Start Date : April 2013
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PEGPH20
PEGPH20+nab-paclitaxel+Gemcitabine
Drug: PEGPH20+nab-paclitaxel+gemcitabine
PEGPH20 3ug/kg + nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2. PEGPH20 given IV x2/week for Cycle 1 and weekly for Cycle 2 and beyond. Nab-paclitaxel and gemcitabine given IV x1/week for 3 weeks for all cycles.
Other Names:
  • Abraxane
  • Gemzar
Active Comparator: nab-paclitaxel + gemcitabine
nab-paclitaxel + gemcitabine x1/week
Drug: nab-paclitaxel + gemcitabine
nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 given IV x1/week 3/4 weeks per cycle
Other Names:
  • Abraxane
  • Gemzar


Outcome Measures

Primary Outcome Measures :
  1. Estimate the PFS duration of PEGPH20 combined with NAB plus GEM [ Time Frame: 12 months ]
  2. To evaluate the thromboembolic events in subjects treated in the PAG arm [ Time Frame: Ongoing ]

Secondary Outcome Measures :
  1. Estimate relative benefit of PAG treatment vs. AG treatment, as assessed by the PFS ratio [ Time Frame: 1 year ]
  2. Estimate relative benefit of PAG vs AG treatment as assessed by the PFS hazard ratio based on subject tumor-associated HA levels [ Time Frame: 1 year ]
  3. Estimate ORR as defined by RECIST 1.1 of PAG treatment and the relative benefit of PAG treatment vs AG treatment [ Time Frame: 1 year ]
  4. To estimate the OS duration of PAG treatment and the relative benefit of PAG treatment vs AG treatment, as assessed by the OS hazard ratio. [ Time Frame: 16 months ]
  5. To evaluate the safety and tolerability profile of PAG and AG treatment groups [ Time Frame: 1 year ]
  6. To characterize the plasma PK of PEGPH20 when given in combination with NAB + GEM [ Time Frame: Various visits and timepoints ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Signed Informed consent
  • Histologically confirmed Stage IV pancreatic ductal adenocarcinoma w/ documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
  • One or more measurable metastatic tumors measurable on CT san per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 ), excluding the primary lesion.
  • No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
  • Karnofsky Performance Status >= 70%
  • Life expectancy >= 3 mos
  • Age >= 18 years
  • Screen labs of Hemoglobin, platelets, absolute neutrophil count (ANC), bilirubin, AST, ALT, serum creatinine, serum albumin, PT/INR, and PTT within specified values/criteria per protocol prior to dosing.

Key Exclusion Criteria:

  • Non metastatic pancreatic ductal adenocarcinoma
  • Evidence of deep vein thrombosis (DVT) or pulmonary embolism (PE) or other known thromboembolic event present during screening period.
  • Known Central nervous system involvement, brain metastasis
  • New York(NY) Heart Association Class III or IV cardiac disease or Myocardial infarction within the past 12 months.
  • Prior history of cerebrovascular accident or transient ischemic attack
  • Pre-existing carotid artery disease
  • Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
  • Current use of megestrol acetate (Use within 10 days of Day 1)
  • Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C
  • History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early state prostate cancer, or curatively-treated cervical cancer in-situ.
  • Contraindication to heparin as per NCCN guidelines
  • Previous major bleed (bleeding requiring transfusion of red blood cells) on LMWH
  • Any other disease, metabolic dysfunction, physical examination finding or clinical lab finding that leads to reasonable suspicion of disease or condition that contraindicates the use of an investigational drug, that may affect interpretation of results, or render the subject at a high risk of treatment complications.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839487


  Show 52 Study Locations
Sponsors and Collaborators
Halozyme Therapeutics
Investigators
Study Director: Dimitrios Chondros, MD Halozyme Therapeutics
More Information

Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT01839487     History of Changes
Other Study ID Numbers: HALO-109-202
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016

Keywords provided by Halozyme Therapeutics:
pancreatic ductal carcinoma(PDA)
Pancreatic ductal carcinoma
PEGPH20
Gemcitabine
Nab-paclitaxel

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs