PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
Status and phase
Completed
Phase 2
Conditions
Metastatic Pancreatic Cancer
Treatments
Drug: Gemcitabine
Drug: Enoxaparin
Drug: PEGPH20
Drug: Dexamethasone
Drug: Nab-paclitaxel
Details and patient eligibility
About
This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).
The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG).
This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
Enrollment
279 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- Signed Informed consent.
- Histologically confirmed Stage IV PDA with documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
- One or more metastatic tumors measurable on computed tomography (CT) scan per RECIST v.1.1 , excluding the primary pancreatic lesion.
- No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
- Karnofsky Performance Status greater than or equal to (≥) 70%.
- Life expectancy ≥3 months.
- Age ≥18 years.
- Screening laboratory values of hemoglobin, platelets, absolute neutrophil count (ANC), bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum creatinine, serum albumin, prothrombin time/international normalized ratio (INR), and partial thromboplastin time (PTT) within specified values/criteria per protocol prior to dosing.
Key Exclusion Criteria:
- Non-metastatic PDA.
- Evidence of deep vein thrombosis (DVT), pulmonary embolism (PE), or other known thromboembolic event present during screening period.
- Known central nervous system involvement or 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 National Comprehensive Cancer Network (NCCN) guidelines.
- Previous major bleed (bleeding requiring transfusion of red blood cells) on low-molecular weight heparin (LMWH).
- Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory 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 participant at a high risk of treatment complications.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
279 participants in 6 patient groups
Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine
Experimental group
Description:
Participants will receive 3.0 micrograms/kilogram (mcg/kg) PEGPH20 with 125 milligrams/square meter (mg/m\^2) NAB and 1000 mg/m\^2 GEM as intravenous (IV) infusion. In Cycle 1 Week 1, PEGPH20 will be administered alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15 and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1 8 and 15. NAB+GEM will be given 2 to 4 hours after PEGPH20 dose. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior and 8 to 12 hours after completion of each PEGPH20 infusion.
Treatment:
Drug: Nab-paclitaxel
Drug: PEGPH20
Drug: Dexamethasone
Drug: Gemcitabine
Run-in Phase - AG: Nab-paclitaxel + Gemcitabine
Active Comparator group
Description:
Participants will receive 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM, as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
Treatment:
Drug: Nab-paclitaxel
Drug: Dexamethasone
Drug: Gemcitabine
Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine
Experimental group
Description:
Participants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and Day 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion.
Treatment:
Drug: Nab-paclitaxel
Drug: PEGPH20
Drug: Dexamethasone
Drug: Gemcitabine
Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine
Active Comparator group
Description:
Participants will receive 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
Treatment:
Drug: Nab-paclitaxel
Drug: Dexamethasone
Drug: Gemcitabine
Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine
Experimental group
Description:
Participants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to beginning and 8 to 12 hours after completion of each PEGPH20 infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given subcutaneously (SC).
Treatment:
Drug: Nab-paclitaxel
Drug: PEGPH20
Drug: Dexamethasone
Drug: Enoxaparin
Drug: Gemcitabine
Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine
Active Comparator group
Description:
Participants will receive 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given SC.
Treatment:
Drug: Nab-paclitaxel
Drug: Dexamethasone
Drug: Enoxaparin
Drug: Gemcitabine
Trial contacts and locations
51
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Data sourced from clinicaltrials.gov
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