Pancreatic Cancer, Stage IV Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, Stage IV Pancreatic Cancer
Brief summary
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine.
Detailed description
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up to approximately 34 patients may be enrolled into the study.
Interventions
DRUGVantictumab
Administered intravenous (IV) infusion.
DRUGNab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
DRUGGemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.
Sponsors
OncoMed Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form * Age ≥18 years * Histologically documented Stage IV ductal adenocarcinoma of the pancreas * Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy * ECOG performance status of 0 or 1 * Adequate hematologic and end-organ function * Evaluable or measurable disease per RECIST v1.1 * For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception
Exclusion criteria
* Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer * Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas * Known hypersensitivity to any component of study treatments * Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer | Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28) | The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer | Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle. | Apparent half life, AUC, clearance, volume of distribution |
Countries
United States
Outcome results
None listed