PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer (HALO-109-202)
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).
Metastatic Pancreatic Cancer
Drug: nab-paclitaxel + gemcitabine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- Estimate the PFS duration of PEGPH20 combined with NAB plus GEM [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To evaluate the thromboembolic events in subjects treated in the PAG arm [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
- Estimate relative benefit of PAG treatment vs. AG treatment, as assessed by the PFS ratio [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- To evaluate the safety and tolerability profile of PAG and AG treatment groups [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To characterize the plasma PK of PEGPH20 when given in combination with NAB + GEM [ Time Frame: Various visits and timepoints ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
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.
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
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.
- 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.
- 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
- 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.
- Subjects continue in study until disease progression, adverse event/toxicity, death or either the subject/sponsor discontinues the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839487
|Contact: Sam Dychter, MDemail@example.com|
|Contact: Lisa Schechet, BSNfirstname.lastname@example.org|
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|Study Director:||Samuel S. Dychter, MD||Halozyme Therapeutics|