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Enzyme
Calaspargase + Cobimetinib for Pancreatic Cancer
Phase 1
Recruiting
Led By Charles D Lopez
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically-proven adenocarcinoma of the exocrine pancreas with locally advanced or metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after last dose of study intervention
Awards & highlights
Study Summary
This trial is testing the safety and best dose of two drugs to treat pancreatic cancer. One drug, calaspargase pegol-mknl, starves cancer cells of a nutrient they need. The other drug, cobimetinib, attacks a protein that stimulates cancer cell growth.
Who is the study for?
Adults with advanced or metastatic pancreatic cancer who have not responded to, cannot tolerate, or refused standard treatments like Gemcitabine-based therapy or FOLFORINOX. They must be in relatively good health (ECOG 0-2), have acceptable blood counts and organ function, and agree to use non-hormonal contraception. Pregnant women, those with certain heart conditions, severe allergies to trial drugs, uncontrolled medical issues, or recent other cancer therapies are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of Calaspargase Pegol-mknl and Cobimetinib for safety and optimal dosing against pancreatic cancer that has spread. Calaspargase Pegol-mknl deprives cancer cells of a needed amino acid while Cobimetinib blocks a protein that helps these cells grow.See study design
What are the potential side effects?
Potential side effects include allergic reactions to the medications used; changes in blood counts leading to increased risk of infections; liver problems indicated by altered lab tests; fatigue; digestive issues such as nausea and vomiting; potential heart rhythm problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pancreatic cancer is confirmed and has spread.
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I can take care of myself and am up and about more than half of the day.
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I am 18 years old or older.
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I have at least one tumor that can be biopsied.
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My hemoglobin level is at least 9.0 g/dL without recent blood transfusions.
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My kidney function, measured by creatinine levels, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after last dose of study intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after last dose of study intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities (DLTs)
Secondary outcome measures
Disease control rate (DCR)
Incidence of treatment-emergent adverse events (AEs) and serious AEs
Mean plasma asparaginase activity
+1 moreOther outcome measures
Therapy induced changes in the tumor and tumor ecosystem
Side effects data
From 2021 Phase 3 trial • 166 Patients • NCT0067103464%
Neutrophil count decreased
54%
Febrile neutropenia
43%
Platelet count decreased
43%
Infections and infestations - Other, specify
36%
Alanine aminotransferase increased
36%
Hypokalemia
30%
Hyperglycemia
28%
White blood cell decreased
26%
Anemia
23%
Mucositis oral
19%
Hypocalcemia
19%
Anaphylaxis
17%
Hyponatremia
17%
Blood bilirubin increased
16%
Abdominal pain
16%
Anorexia
14%
Aspartate aminotransferase increased
13%
Nausea
13%
Hyperkalemia
13%
Hypophosphatemia
12%
Pancreatitis
12%
Hypoalbuminemia
12%
Serum amylase increased
12%
Diarrhea
12%
Lung infection
12%
Hypoxia
10%
Lipase increased
10%
Hypotension
9%
Oral pain
9%
Pleural effusion
7%
Vomiting
7%
Hypertriglyceridemia
7%
Thromboembolic event
7%
Pain
7%
Enterocolitis infectious
7%
Weight loss
7%
Back pain
6%
Death NOS
6%
Fibrinogen decreased
6%
Urinary tract infection
4%
GGT increased
4%
Dyspnea
4%
Fatigue
4%
Activated partial thromboplastin time prolonged
4%
Hypertension
4%
Sepsis
4%
Skin infection
4%
Alkaline phosphatase increased
4%
Pharyngolaryngeal pain
4%
Epistaxis
4%
Upper respiratory infection
4%
Generalized muscle weakness
4%
Pain in extremity
4%
Fever
3%
Catheter related infection
3%
Anal pain
3%
Hyperuricemia
3%
Glucose intolerance
3%
Avascular necrosis
3%
Cholesterol high
3%
Dehydration
3%
Depression
3%
Acute kidney injury
3%
Adult respiratory distress syndrome
3%
Oral hemorrhage
3%
Non-cardiac chest pain
3%
Pharyngitis
3%
Creatinine increased
3%
Acidosis
3%
Hypercalcemia
3%
Tumor lysis syndrome
3%
Arthralgia
3%
Nervous system disorders - Other, specify
3%
Rash maculo-papular
3%
Vascular disorders - Other, specify
3%
Dysphasia
3%
Encephalopathy
3%
Headache
3%
Typhlitis
3%
Seizure
3%
Syncope
3%
Agitation
1%
Hematoma
1%
Irritability
1%
Ascites
1%
Investigations - Other, specify
1%
Tremor
1%
Dizziness
1%
Pancreatic necrosis
1%
Infective myositis
1%
INR increased
1%
Esophagitis
1%
Peripheral nerve infection
1%
Wound infection
1%
Injury, poisoning and procedural complications - Other, specify
1%
Purpura
1%
Lymphocyte count decreased
1%
Joint effusion
1%
Muscle weakness right-sided
1%
Musculoskeletal and connective tissue disorder - Other, specify
1%
Anxiety
1%
Chronic kidney disease
1%
Blood and lymphatic system disorders - Other, specify
1%
Disseminated intravascular coagulation
1%
Ileus
1%
Anorectal infection
1%
Lip infection
1%
Paronychia
1%
Scrotal infection
1%
Sinusitis
1%
Weight gain
1%
Cerebrospinal fluid leakage
1%
Depressed level of consciousness
1%
Intracranial hemorrhage
1%
Pneumonitis
1%
Psychiatric disorders - Other, specify
1%
Personality change
1%
CPK increased
1%
Myositis
1%
Leukoencephalopathy
1%
Colitis
1%
Mucosal infection
1%
Pharyngeal mucositis
1%
Alkalosis
1%
Bone pain
1%
Abducens nerve disorder
1%
Psychosis
1%
Neuralgia
1%
Suicidal ideation
1%
Hemolysis
1%
Supraventricular tachycardia
1%
Left ventricular systolic dysfunction
1%
Middle ear inflammation
1%
Eye disorders - Other, specify
1%
Retinal detachment
1%
Vasovagal reaction
1%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Calaspargase Pegol 2100)
Arm II (Calaspargase Pegol 2500)
Arm III (Pegaspargase 2500)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (calaspargase pegol-mknl, cobimetinib)Experimental Treatment3 Interventions
Patients receive calaspargase pegol-mknl IV over 1 hour on day 1 and cobimetinib PO QD on days 1-14. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Calaspargase Pegol-mknl
2008
Completed Phase 3
~170
Cobimetinib
2017
Completed Phase 3
~3090
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,038 Total Patients Enrolled
Servier Pharmaceuticals, LLCUNKNOWN
1 Previous Clinical Trials
OHSU Knight Cancer InstituteLead Sponsor
231 Previous Clinical Trials
2,090,676 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to calaspargase pegol-mknl, cobimetinib, or similar drugs.My pancreatic cancer is confirmed and has spread.I am not taking any strong or moderate drugs that affect liver enzymes.My high blood pressure is not under control.I have a history of or current issues with specific eye conditions.I can take care of myself and am up and about more than half of the day.You have a severe blood clotting problem that is not under control.I have a history of chronic or recurrent pancreatitis, or currently have signs of acute pancreatitis.I have a condition that affects my ability to swallow or absorb pills.I have been treated with L-asparaginase before.I haven't had serious heart issues or a stroke in the last 6 months.I do not have an ongoing serious infection that isn't getting better with treatment.You have a prolonged QT interval or other heart-related issues that can increase the risk of heart rhythm problems.Your white blood cell count is higher than 3 billion per liter.I am 18 years old or older.Your disease must be able to be measured using specific guidelines called RECIST version 1.1.I have at least one tumor that can be biopsied.My condition worsened or I couldn't tolerate standard chemotherapy.My hemoglobin level is at least 9.0 g/dL without recent blood transfusions.Your body has enough infection-fighting white blood cells.My kidney function, measured by creatinine levels, is within the normal range.Your platelet count is at least 100,000 per mm^3.Your bilirubin level in the blood should be less than 1.5 times the normal upper limit set by the hospital.Your AST and ALT levels should not be more than 2.5 times the upper limit of normal.I haven't taken any cancer drugs or been in a study for at least 30 days.I do not have any severe or uncontrolled health conditions like diabetes or high blood pressure.I am not on any other cancer treatments or live vaccines while on the study medication.I have a serious blood clotting issue that isn't under control.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (calaspargase pegol-mknl, cobimetinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide an estimate of the total participant count for this research endeavor?
"Confirmed. The data on clinicaltrials.gov demonstrates that the trial, which was initially advertised on August 9th 2022, is actively seeking volunteers. A total of 24 patients are needed at one particular medical centre."
Answered by AI
Is enrollment for this experiment open at this time?
"Yes, the information hosted on clinicaltrials.gov reveals that this research study is actively recruiting participants. The project was initially posted on August 9th 2022 and has been recently revised as of September 8th 2022. 24 volunteers are required to be enrolled across a single medical centre."
Answered by AI
How has Calaspargase Pegol-mknl been evaluated for safety in humans?
"Due to the small sample size of data available, our team at Power rated Calaspargase Pegol-mknl a score of 1 on safety due its Phase 1 trial status."
Answered by AI
What conditions is Calaspargase Pegol-mknl commonly employed to address?
"Calaspargase Pegol-mknl is a popular treatment option for unresectable melanoma, as well as lymphoma, acute lymphoblastic leukemia (ALL), and chemotherapy."
Answered by AI
What prior studies have been conducted that focus on the effectiveness of Calaspargase Pegol-mknl?
"Currently, 87 trials of Calaspargase Pegol-mknl are underway with twenty one in Phase 3. Portland, Oregon is hosting several studies for this compound but it is being researched across 5,522 sites worldwide."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
OHSU Knight Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
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