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AZD0171 + Durvalumab + Chemotherapy for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status of 0 or 1 at screening/enrollment
Presence of tumoral CD8+ T cells based on a predetermined benchmarked PDAC external sample
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial will test a new combination of drugs to treat pancreatic cancer.

Who is the study for?
This trial is for adults with metastatic pancreatic cancer who are in good physical condition (ECOG 0 or 1) and have a specific immune score. They must have at least one measurable tumor lesion, weigh over 35 kg, and provide tissue samples. Excluded are those with active infections, recent serious heart issues, other cancers, immunosuppressive treatments within the last two weeks, certain autoimmune diseases or prior cancer therapies.Check my eligibility
What is being tested?
The study tests AZD0171 combined with Durvalumab and standard chemotherapy drugs Gemcitabine and Nab-paclitaxel in patients with advanced pancreatic cancer. It aims to assess safety, how the body processes these drugs (pharmacokinetics), and their effectiveness against tumors.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system affecting various organs due to Durvalumab; typical chemotherapy-related effects like nausea, fatigue from Gemcitabine; hair loss and nerve damage from Nab-paclitaxel; plus any new side effects from AZD0171.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer shows a specific immune response.
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My body weight is at least 35 kg.
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I have been diagnosed with a type of pancreatic cancer that has spread.
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My cancer shows a specific immune response.
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My body weight is at least 35 kg.
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My organ and bone marrow functions are normal.
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I have been diagnosed with a type of pancreatic cancer that has spread.
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My organ and bone marrow functions are normal as tested within the last 28 days.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events (AEs), immune mediated AEs (imAEs) and serious AEs (SAEs)
Overall survival at 12 months (OS-12)
Secondary outcome measures
Change from baseline in leukaemia inhibitory factor (LIF) bound to AZD0171 (total LIF)
Disease control rate (DCR)
Duration of response (DoR)
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AZD0171 + Durvalumab + chemotherapyExperimental Treatment4 Interventions
Participants will receive AZD0171 (intravenous [IV]) along with durvalumab (IV) in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,471,295 Total Patients Enrolled

Media Library

AZD0171 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04999969 — Phase 2
Solid Tumors Research Study Groups: AZD0171 + Durvalumab + chemotherapy
Solid Tumors Clinical Trial 2023: AZD0171 Highlights & Side Effects. Trial Name: NCT04999969 — Phase 2
AZD0171 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04999969 — Phase 2

Frequently Asked Questions

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

What is the maximum capacity for participants in this experiment?

"Affirmative. Clinicaltrials.gov conveys that this research, which was initially posted on December 10th 2021, is currently seeking participants. 115 individuals are expected to be recruited from 25 separate medical centers."

Answered by AI

Is there a sizeable presence of this trial within North America?

"This clinical trial is taking place in 25 medical centres across the nation, including Newton, Grand Rapids and Charlottesville. It would be beneficial to choose a clinic that is nearby your residence if you decide to participate, so as to minimize travel requirements."

Answered by AI

Does this clinical study encompass individuals under the age of twenty-five?

"The criteria for entry into this study calls for participants to be older than 18 and more youthful than 130."

Answered by AI

What aims is this medical study attempting to accomplish?

"Investigating the efficacy of this intervention is the primary purpose of this clinical trial. Until 90 days post-treatment, overall survival at 12 months (OS-12) will be monitored as a measure of success. Secondary outcomes include investigations into terminal elimination half-life, median overall survival and maximum observed plasma concentration for AZD0171, durvalumab and chemotherapy treatments or their metabolites."

Answered by AI

Is enrolment to this trial still accessible for patients?

"Clinicaltrials.gov states that the recruitment of participants for this trial is ongoing and has been since December 10th, 2021. The most recent update to the study's information was on November 3rd 2022."

Answered by AI

Would I meet the qualifications to partake in this clinical experiment?

"Patients must fit the parameters of 18 to 130 years old and possess locally advanced or metastatic solid tumours in order to partake in this experiment. Approximately 115 individuals will be accepted into the study."

Answered by AI

What are the usual applications of AZD0171?

"AZD0171 is frequently prescribed for malignant peritoneal neoplasm and has been tested as a treatment for conditions including untreated cases of anthracycline-containing therapy."

Answered by AI

Has AZD0171 been granted permission by the FDA?

"The safety of AZD0171 was rated a 2 since there is evidence that suggests its safe, however no data exists to prove it's efficacy."

Answered by AI

Could you elucidate on the additional research that has been done utilizing AZD0171?

"AZD0171 was first explored by City of Hope Comprehensive Cancer Center back in 1997, and since then 1956 clinical trials have been brought to a successful close. At present, 1389 independent studies are underway with numerous being conducted out of Newton, Massachusetts."

Answered by AI
~23 spots leftby Oct 2024