Pancreatic CancerPhase 2NCT01020006
Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
A Phase 2 study testing PCI-27483 and Gemcitabine in people with Pancreatic Cancer and Ductal Adrenocarcinoma, run by Pharmacyclics LLC. at 17 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of selected dose 1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or locally advanced pancreatic cancer patients receiving concurrent therapy with intravenously administered gemcitabine for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Ductal Adrenocarcinoma, Exocrine Pancreatic Cancer
- What is being tested?
- PCI-27483 and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2009to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women at least 18 years old
- Body weight ≥ 40 and ≤ 100 kg.
- Part A: Metastatic ductal adenocarcinoma of the pancreas diagnosed ≤ 4 months prior to enrollment. (Locally advanced does not have any criteria)
- Part B: Locally advanced ductal adenocarcinoma of the pancreas diagnosed ≤ 3 months prior to enrollment or metastatic ductal adenocarcinoma diagnosed ≤ 2 months.
- Measurable disease by spiral CT scan (SCT) in accordance with RECIST criteria.
- Patients after non-curative surgery are eligible if at least 4 weeks after surgery and recovered from significant surgical morbidity.
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- Estimated life expectancy of at least 4 months.
- ECOG performance status 0 to 1.
- Normal baseline coagulation function as defined by:
- PT 10-16 seconds, and
- aPTT 22-38 seconds.
- Agree to not participate in contact sports or strenuous activity while taking PCI-27483.
- Ability to understand the study, willingness to participate in the study for the study duration, and ability to provide written informed consent to participate.
Who cannot join
- History of any clinically significant medical condition that, in the opinion of the Principal Investigator, would interfere with the study evaluation or interpretation.
- Known history of brain metastases.
- Any evidence of intra-cranial hemorrhage based on head CT scan within 30 days of enrollment.
- History of disease progression while being treated with gemcitabine.
- Radiotherapy of the primary tumor or unwillingness to defer radiotherapy of the primary tumor until > 3 months from initiation of treatment.
- History of venous thromboembolism (eg, deep vein thrombosis, pulmonary embolism,and arterial thromboembolism) or other indications for anticoagulant treatment (eg,mechanical heart values, atrial fibrillation, etc.) within the last year. Local thrombus in the mesenteric or portal vein is acceptable.
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- Uncontrolled hypertension (systolic > 160 or diastolic > 100 mm Hg on medical treatment).
- Continued anticoagulation therapy or anticoagulation therapy within 2 months prior to enrollment, except for perisurgical prophylaxis which must have ceased 2 weeks before enrollment.
- Contraindication to systemic anticoagulation.
- Continued treatment with antiplatelet drugs including aspirin, clopidogrel, etc. within the past 72 hours.
- Known history of clinically significant or recurrent bleeding episodes, including significant bleeding after surgery, childbirth, or dental extraction.
- Patients with documented invasion of adjacent organs by CT scan (e.g. stomach, duodenum) are not eligible
- Patients known to have esophageal varicose are not eligible
- Known history of a congenital coagulation factor deficiency.
- Known acquired or hereditary platelet disorder.
- Known history of immunodeficiency.
- Women of child-bearing potential or sexually active men, unwilling to use adequate contraceptive protection during the course of the study.
- Pregnant or lactating women (female patients of childbearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or if positive, pregnancy ruled out by ultrasound).
- Laboratory Abnormalities:
- Serum creatinine > 2 mg/dL or creatinine clearance < 50 mL/minute (using Cockroft Gault formula)
- AST and ALT ≥ 4.0 x upper limit of normal (ULN).
- Bilirubin ≥ 3 mg/dL.
- Alkaline phosphatase > 5 x ULN.
- Albumin < 2.0g/dL.
- Hemoglobin < 9.0 g/dL.
- Platelet count < 100,000/μL.
- Evidence of active gastrointestinal tract bleeding, including guaiac stool positivity,excluding hemorrhoidal bleeding
- Chronic active hepatitis B or C.
- Known HIV infection.
- Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to enrollment, or planned participation within the study duration.
- Risk factors for, or use of medications known to prolong QTc interval or that may be associate with Torsades de Pointes within 7 days of treatment start (see Appendix J. Risk Factors for Drug-induced Torsades de Pointes).
- QTc prolongation (defined as a QTc ≥ 450 msec) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min). If 2 screening ECGs have a QTc ≥ 450 msec, the ECGs can be submitted for a centralized, cardiologic evaluation and if determined to be < 450 msec then the patient is eligible.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Summa Health System
Akron, Ohio, 44304
Pacific Cancer Medical Center
Anaheim, California, 92081
University of Vermont/Vermont Cancer Center
Burlington, Vermont, 05401
Gabrail Cancer Center Research
Canton, Ohio, 44718
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29414
Associates in Oncology and Hematology
Chattanooga, Tennessee, 37404
Sammons Cancer Center
Dallas, Texas, 75246
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Kenthucky Cancer Clinic
Hazard, Kentucky, 41701
South Carolina Cancer Specialists, PA
Hilton Head, South Carolina, 29926
Investigative Clinical Research of Indiana
Indianapolis, Indiana, 46260
Beth Israel Cancer Center
New York, New York, 10003
Columbia University
New York, New York, 10032
University of Rochester
Rochester, New York, 14642
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426
TGen Clinical Reserch Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258
Space Coast Medical Associates
Titusville, Florida, 32796
About this study
Official title: Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
The purpose of this study is to evaluate the safety and tolerability of selected dose 1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or locally advanced pancreatic cancer patients receiving concurrent therapy with intravenously administered gemcitabine for 12 weeks.
Read the detailed description
This study will be conducted in three segments: Part A, Part B and Part C. Parts A and B are 12 weeks of treatment followed by 4 weeks of evaluation. In part A patients will dose-escalate up to three dose levels of PCI-27483 administered as subcutaneous (SC) injections twice-daily (BID). Part B to start once 4th patient completes 90 of 112 doses in 8 weeks. In part B patients are randomized to PCI-27483 and gemcitabine (active arm) OR gemcitabine only (control arm). PCI-27483 doses in both Part A and B will be administered in combination with a standard regimen of gemcitabine. Patients with a tumor response or stable disease at 12 weeks will have the opportunity to continue PCI-27483 treatment until disease progression or the Investigator considers the study treatment to be no longer tolerable. Treatment with gemcitabine in either the active or control arm may continue until a standard course of gemcitabine therapy has been completed. Patients will complete Part A or Part B after 16 weeks on study regardless of treatment duration. Evaluable patients will roll over into part C and be followed for 12 months from enrollment (first dose).
- Being tested
- PCI-27483, Gemcitabine
- Keywords
- PCI-27483, Factor VIIa, Gemcitabine, 4 months life expectancy, Pharmacyclics, Locally Advanced, Metastatic disease
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI-27483Drug
Also called PCYC-1001, PCI-27483 Injection
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.
GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Active comparator | Subjects receive Gemcitabine 1000 mg/m2 weekly intravenous infusion. Receives: Drug: Gemcitabine |
| 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. Receives: Drug: PCI-27483; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (AEs)
Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0
Measured: First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Hedrick, MD, Study director, Pharmacyclics LLC.Laurence Elias, MD, Study director, Pharmacyclics LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020006
- Sponsor's protocol ID
- PCYC-1001
- Status last verified
- Apr 2014
- First submitted
- 20 Nov 2009
- Last updated
- 24 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
- ClinicalTrials.gov ID
- NCT01020006
- Acronym / sponsor ID
- PCYC-1001
- Keywords
- PCI-27483, Factor VIIa, Gemcitabine, 4 months life expectancy, Pharmacyclics, Locally Advanced, Metastatic disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2012 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of selected dose 1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or locally advanced pancreatic cancer patients receiving concurrent therapy with intravenously administered gemcitabine for 12 weeks.
Detailed description
This study will be conducted in three segments: Part A, Part B and Part C. Parts A and B are 12 weeks of treatment followed by 4 weeks of evaluation. In part A patients will dose-escalate up to three dose levels of PCI-27483 administered as subcutaneous (SC) injections twice-daily (BID). Part B to start once 4th patient completes 90 of 112 doses in 8 weeks. In part B patients are randomized to PCI-27483 and gemcitabine (active arm) OR gemcitabine only (control arm). PCI-27483 doses in both Part A and B will be administered in combination with a standard regimen of gemcitabine. Patients with a tumor response or stable disease at 12 weeks will have the opportunity to continue PCI-27483 treatment until disease progression or the Investigator considers the study treatment to be no longer tolerable. Treatment with gemcitabine in either the active or control arm may continue until a standard course of gemcitabine therapy has been completed. Patients will complete Part A or Part B after 16 weeks on study regardless of treatment duration. Evaluable patients will roll over into part C and be followed for 12 months from enrollment (first dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Active comparator | Drug: GemcitabineSubjects receive Gemcitabine 1000 mg/m2 weekly intravenous infusion. |
| PCI-27483 + Gemcitabine | Experimental | Drug: PCI-27483, Drug: GemcitabinePart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Men or women at least 18 years old
- Body weight ≥ 40 and ≤ 100 kg.
- Part A: Metastatic ductal adenocarcinoma of the pancreas diagnosed ≤ 4 months prior to enrollment. (Locally advanced does not have any criteria)
- Part B: Locally advanced ductal adenocarcinoma of the pancreas diagnosed ≤ 3 months prior to enrollment or metastatic ductal adenocarcinoma diagnosed ≤ 2 months.
- Measurable disease by spiral CT scan (SCT) in accordance with RECIST criteria.
Key exclusion criteria (32 listed)
- History of any clinically significant medical condition that, in the opinion of the Principal Investigator, would interfere with the study evaluation or interpretation.
- Known history of brain metastases.
- Any evidence of intra-cranial hemorrhage based on head CT scan within 30 days of enrollment.
- History of disease progression while being treated with gemcitabine.
- Radiotherapy of the primary tumor or unwillingness to defer radiotherapy of the primary tumor until > 3 months from initiation of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI-27483Also: PCYC-1001, PCI-27483 InjectionPart 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. | Drug | PCI-27483 + Gemcitabine |
| Gemcitabine | Drug | Gemcitabine, PCI-27483 + Gemcitabine |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (AEs)
Time frame: First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).
Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hedrick, MD study director
Pharmacyclics LLC.
Laurence Elias, MD study director
Pharmacyclics LLC.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCI-27483 and Gemcitabine in people with Pancreatic Cancer and Ductal Adrenocarcinoma, run by Pharmacyclics LLC. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (AEs) (time frame: First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.