Phase 2
Completed N=28
Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
Source: ClinicalTrials.gov NCT01453153 ↗Enrolled (actual)
28
Serious AEs
57.1%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants With a Dose-limiting Toxicity (DLT) — 0; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Dose-limiting Toxicity (DLT) |
0; 0; 0 | — |
| PRIMARY Recommended Phase 2 Dose (RP2D) |
3.0 | — |
| SECONDARY Observed Maximum Plasma Concentration (Cmax) Following Single PEGPH20 Doses |
0.604; 1.54; 3.18 | — |
| SECONDARY Cmax Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks |
1.08; 2.40; 3.98 | — |
| SECONDARY Last Measurable Observed Plasma Concentration (Cmin) Following Single PEGPH20 Doses |
0.626; 0.651; 0.864 | — |
| SECONDARY Cmin Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks |
0.572; 0.976; 1.52 | — |
| SECONDARY Time to Reach Cmax (Tmax) Following Single PEGPH20 Doses |
0.250; 0.250; 0.420 | — |
| SECONDARY Tmax Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks |
0.330; 0.325; 0.420 | — |
| SECONDARY Apparent Half-life (t1/2) Following Single PEGPH20 Doses |
18.6; 8.24 | — |
| SECONDARY t1/2 Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks |
5.60; 19.5; 10.7 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Measurable Plasma Concentration (AUC0-T) Following Single PEGPH20 Doses |
1.39; 13.6; 31.5 | — |
| SECONDARY AUC0-T Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks |
2.99; 21.5; 35.2 | — |
| SECONDARY Plasma Hyaluronan (HA) Concentration at Baseline and After PEGPH20 Administration |
123.7; 982.3; 164.7; 7288; 27818; 128411 | — |
| SECONDARY H-scores, as an Assessment of HA Staining Changes in Tumor Biopsies |
40; 260; 15; 150 | — |
| SECONDARY Percent Change in in the Maximum Standardized Uptake Value (SUVmax), as an Assessment of Total Lesion Metabolic Activity |
-36.7; -43.2; -39.3; -41.2 | — |
| SECONDARY Mean Volume Transfer Constant (Ktrans) for Scans Across Tissue Sites |
0.124; 0.383; NA; 0.430; 0.468; NA | — |
| SECONDARY Mean Extravascular-Extracellular Volume Fraction (Ve) for Scans Across Tissue Sites |
0.162; 0.327; NA; 0.671; 0.386; NA | — |
| SECONDARY Number of Participants With the Indicated Best Response, Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 |
0; 0; 0; 0; 2; 8 | — |
| SECONDARY Objective Response Rate |
0; 2; 8 | — |
| SECONDARY Disease Control Rate |
1; 4; 14 | — |
| SECONDARY Progression-free Survival (PFS) |
47.0; 276.0; 113.0 | — |
| SECONDARY Overall Survival |
109.5; 199.5; 220.0 | — |
| SECONDARY Change From Baseline in Carbohydrate Antigen 19-9 or Sialylated Lewis(a) Antigen (CA19-9) |
12897.5; -7833.9; -11800.3; 0.0; -1.9; -15464.1 | — |
| SECONDARY Change From Baseline in CA19-9 in Participants With a Baseline Value >=59 U/ml |
19346.2; -23500.0; -15018.9; -18274.5; -20724.4; -16835.7 | — |
| SECONDARY Change From Baseline in CA19-9 in Participants Classified as Responders and Non-responders |
-15677.1; 675.7; -16367.0; -6227.9; -21587.2; 1377.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01453153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.