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PCI-27483 · 1 trial · 3 indications
Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0
| Arm | Type | Description |
|---|---|---|
| Gemcitabine | ACTIVE_COMPARATOR | Subjects receive Gemcitabine 1000 mg/m2 weekly intravenous infusion. |
| PCI-27483 + Gemcitabine | EXPERIMENTAL | Part A: Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion. Part B: Subjects received the PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| PCI-27483 | DRUG | Part A: Closed to enrollment.Part B: Approximately 20 patients will be randomized to the control arm that will receive a standard regimen of gemcitabine and 20 patients will be randomized to the PCI-27483 arm and treated with both gemcitabine and PCI-27483. PCI-27483 will be administered as subcutaneous (SC) injections, nominally at a dosage of 1.2 mg/kg BID. Patients receiving PCI-27483 with a tumor response or stable disease at 12 weeks will have the option to continue PCI-27483 treatment until disease progression or the investigator considers the study treatment no longer tolerable. Treatment with gemcitabine may continue per standard of care. All evaluable patients will roll over into Part C at week 16 (Day 113±5). If 2 consecutive INRs at 2 hours postdose are \>3.50,a reduced dosage will be calculated. |
| Gemcitabine | DRUG | - |
Inclusion Criteria: 1. Men or women at least 18 years old 2. Body weight ≥ 40 and ≤ 100 kg. 3. Part A: Metastatic ductal adenocarcinoma of the pancreas diagnosed ≤ 4 months prior to enrollment. (Locally advanced does not have any criteria) 4. Part B: Locally advanced ductal adenocarcinoma of the pa...
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PCI-27483 is an investigational small molecule being studied for the treatment of pancreatic cancer, including ductal adenocarcinoma and exocrine pancreatic cancer. It was evaluated in patients receiving gemcitabine-based treatment. It is not an approved therapy and remains in clinical development.
PCI-27483 targets coagulation factor VII, also known as F7. It acts as an inhibitor of this target. Factor VII is a serine protease involved in the blood coagulation cascade, and inhibiting it is the mechanism under study in the oncology setting.
PCI-27483 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor associated with the clinical program for this asset.
PCI-27483 is in Phase 2 development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 2 trial in pancreatic cancer has been completed, and no trials are currently listed as active.
PCI-27483 was studied in one Phase 2 trial, NCT01020006, titled a study of safety and tolerability of PCI-27483 in patients with pancreatic cancer receiving treatment with gemcitabine. That trial enrolled 42 patients in the United States, was randomized and active-controlled, and is now completed.
The Phase 2 trial NCT01020006 evaluated PCI-27483 in patients with pancreatic cancer, ductal adenocarcinoma, and exocrine pancreatic cancer who were also receiving gemcitabine. It enrolled 42 participants aged 18 years and older, was randomized and active-controlled, and did not use a double-blind design. It is completed.