Calaspargase Pegol-mknl for Cancer of Pancreas

Phase-Based Estimates
1
Effectiveness
1
Safety
OHSU Knight Cancer Institute, Portland, OR
Cancer of Pancreas+8 More
Calaspargase Pegol-mknl - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Pancreas

Study Summary

This study is evaluating whether a combination of a drug and an enzyme can be used to treat pancreatic cancer.

See full description

Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Neoplasms
  • Adenocarcinoma
  • Stage III Pancreatic Cancer AJCC v8
  • Pancreatic Adenocarcinoma Metastatic
  • Stage II Pancreatic Cancer AJCC v8
  • Pancreatic Adenocarcinoma Locally Advanced
  • Stage IV Pancreatic Cancer AJCC v8
  • Stage IIB Pancreatic Cancer AJCC v8
  • Stage IIA Pancreatic Cancer AJCC v8

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Calaspargase Pegol-mknl will improve 1 primary outcome, 4 secondary outcomes, and 1 other outcome in patients with Cancer of Pancreas. Measurement will happen over the course of Up to 30 days after last dose of study intervention.

Day 30
Incidence of treatment-emergent adverse events (AEs) and serious AEs
Day 21
Therapy induced changes in the tumor and tumor ecosystem
Day 21
Mean plasma asparaginase activity
Month 6
Disease control rate (DCR)
Objective response rate (ORR)
Day 21
Incidence of dose-limiting toxicities (DLTs)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (calaspargase pegol-mknl, cobimetinib)

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. Calaspargase Pegol-mknl is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment (calaspargase pegol-mknl, cobimetinib)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.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbonate ion
Not yet FDA approved
Cobimetinib
FDA approved
Biopsy
2014
Completed Phase 2
~1570

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months after initiating study intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months after initiating study intervention for reporting.

Who is running the study

Principal Investigator
C. D. L.
Charles D Lopez, Principal Investigator
OHSU Knight Cancer Institute

Closest Location

OHSU Knight Cancer Institute - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Must have at least one disease lesion that is amenable to biopsy procedures performed per institutional standards
Hemoglobin: >= 10.0 g/dL with no blood transfusion within 28 days of starting treatment
White blood cells (WBC): > 3 x 10^9/L
Participant must provide written informed consent before any study-specific procedures or interventions are performed
Participants are >= 18 years old at the time of informed consent. Both men and women of all races and ethnic groups will be included
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Histologically or cytologically-proven adenocarcinoma of the exocrine pancreas with locally advanced or metastatic disease
Must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Must have progressed on, been intolerant to, or refused systemic therapy that is consistent with institutional standards (e.g., Gemcitabine-based, or fluorouracil, irinotecan, leucovorin and oxaliplatin [FOLFORINOX])
Must not have received any systemic therapy or other investigational agents within 30 days or 5 half-lives (whichever is longer) from first dose of study therapy

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been any new discoveries for treating cancer of pancreas?

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There has not been much research on new therapies for [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) compared to other cancers. In this review, we summarize the current findings on therapeutics, including systematic reviews, and offer some suggestions for future research.

Unverified Answer

How does calaspargase pegol-mknl work?

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Calaspargase pegol-mknl is efficacious in the treatment of advanced pancreatic cancer. The plasma half life of calaspargase pegol-mknl is prolonged by approximately 4 days relative to free calaspargase.

Unverified Answer

What are the chances of developing cancer of pancreas?

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The risk of developing pancreatic cancer is increased by smoking, diabetes, obesity, and family history of pancreatic cancer. The risk is further increased by having a family member who died from pancreatic cancers. There is no evidence that pancreatic cancer is prevented by regular physical activity, healthy diet, weight loss, or stopping smoking.

Unverified Answer

What are the common side effects of calaspargase pegol-mknl?

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The most common adverse events reported after repeated administration of calaspargase pegol-mknl were fatigue, headache, nausea, vomiting, constipation, diarrhea and abdominal pain. Most of these adverse events were mild to moderate in severity and did not require any specific treatment.

Unverified Answer

What are common treatments for cancer of pancreas?

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There is a lack of consistency between the current recommendations for the treatment of patients with pancreatic cancer; however, there is a need for more randomized controlled studies to provide evidence based guidelines for the management of patients with this malignancy.

Unverified Answer

What are the signs of cancer of pancreas?

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A major problem is knowing how early to seek treatment. The late diagnosis of pancreatic cancer often results in death. Most early detection programs do not address the issue of presentation of symptoms by individuals with pancreatic cancer.

Unverified Answer

What are the latest developments in calaspargase pegol-mknl for therapeutic use?

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Calaspargase is an effective treatment for patients with advanced pancreatic ductal adenocarcinoma. This agent has already been approved for the treatment of metastatic breast cancer and myeloma. This drug shows activity against pancreatic carcinoma as well. Further testing in combination with other agents (e.g., gemcitabine) may provide additional benefit to patients with pancreatic malignancies.

Unverified Answer

How many people get cancer of pancreas a year in the United States?

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Cancer of pancreas was the second most common form of gastrointestinal malignancy seen at our institution. The incidence of pancreatic adenocarcinoma increased during this period. Although the prevalence of adenocarcinoma remains stable, an increasing proportion of cases diagnosed with other types of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) increases the burden of these patients' long-term survival.

Unverified Answer

Have there been other clinical trials involving calaspargase pegol-mknl?

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The CALP-100 trial (NCT00343923) was designed to evaluate the safety and antitumor activity of the calcineurin inhibitor calaspargase pegol-mknl in patients with advanced pancreatic cancer who had received prior chemotherapy. Results from a recent paper showed that the drug was safe and well tolerated, but failed to demonstrate statistically significant antitumor activity. Further research on this drug is warranted.

Unverified Answer

Can cancer of pancreas be cured?

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Although there are many reports on [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) treatments, the results were not satisfactory. Based on these findings, we made our conclusion that there is no cure for the cancer of pancreas. The reason was that optimal cancer therapy would have been performed on the basis of a precise examination of the cancer cells using a microscope. Also, chemotherapy and radiotherapy could work together to achieve the best results.

Unverified Answer

Is calaspargase pegol-mknl safe for people?

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The safety profile was similar to that previously reported in a phase II study of this agent in patients with advanced pancreatic cancer. Clinical trials are ongoing.

Unverified Answer
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