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Anti-metabolites

Arm A for Pancreatic Cancer

Q: What conditions does Pharmacological Study usually address?

<p>While most commonly used to treat locally advanced non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, Pharmacological Study has also been effective in managing metastatic <a href="https://www.withpower.com/clinical-trials/bladder-cancer">bladder cancer</a>, urinary bladder, and mediastinitis.</p>

Phase 1 & 2

Waitlist Available

Led By Jennifer R Eads

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PHASE I STUDY -- ARM A (DOSE LEVEL 1) AND ARM B (DOSE LEVEL 2)

Patients must have a life expectancy of >= 12 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months for 2 years

Awards & highlights

Study Summary

This trial is studying a combination of drugs as a possible treatment for pancreatic cancer.

Eligible Conditions

Pancreatic Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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This is a Phase I study with two groups: Arm A (Dose Level 1) and Arm B (Dose Level 2).

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Your doctor expects you to live for at least 12 more weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 hours after initiation of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 hours after initiation of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 hours after initiation of treatment 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 Dose Limiting Toxicities (DLT)

Progression-free Survival

To Determine the Pharmacokinetics of AZD1775 in Combination With Nab-paclitaxel and Gemcitabine

Secondary outcome measures

Disease Control Rate

Overall Survival

Response Rate

Other outcome measures

Accuracy of change in tumor FDG uptake (SUVmax) between baseline FDG-PET and week 4 FDG-PET as a predictor of progression-free survival

Change in tumor FDG uptake (SUVmax)

Change in tumor FDG uptake (SUVmax) between baseline FDG-PET and week 4 FDG-PET

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment3 Interventions

Patients receive paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and WEE1 inhibitor AZD1775 as in Arm A.

Group II: Arm AExperimental Treatment3 Interventions

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients also receive WEE1 inhibitor AZD1775 PO daily on days 1, 2, 8, 9, 15, and 16.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD1775

2015

Completed Phase 2

~400

Gemcitabine

2017

Completed Phase 3

~2070

Albumin human

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,648 Previous Clinical Trials

40,931,732 Total Patients Enrolled

Jennifer R EadsPrincipal InvestigatorECOG-ACRIN Cancer Research Group

1 Previous Clinical Trials

278 Total Patients Enrolled

Frequently Asked Questions

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

What is the total amount of people that are participating in this research project?

"Presently, this trial is not seeking new patients. The study was originally posted on July 1st, 2014 and was last updated on June 10th, 2021. However, there are 1286 trials for neoplasm metastasis and 1204 Pharmacological Studies that are currently looking for participants."

Answered by AI

Are there similar drugs that have been studied before?

"There are a total of 1204 clinical trials studying Pharmacological Study with 334 currently in Phase 3. While Shanghai, China has the most active trial sites for this research topic, there are a total of 61739 locations around the world where studies are being conducted."

Answered by AI

How many research sites are participating in this trial?

"Patients are being accepted at the Fox Chase Cancer Center in Philadelphia, Pennsylvania, Vanderbilt University/Ingram Cancer Center in Nashville, Tennessee, Northwestern University in Chicago, Illinois as well as 5 additional sites."

Answered by AI

Are there still open slots for volunteers in this experiment?

"Unfortunately, this particular trial is no longer recruiting patients. The listing on clinicaltrials.gov says that the study was posted on July 1st, 2014 and last updated June 10th, 2021. Although this study has wrapped up recruitment, there are 2,490 other trials searching for volunteers as we speak."

Answered by AI

What conditions does Pharmacological Study usually address?

"While most commonly used to treat locally advanced non-small cell lung cancer, Pharmacological Study has also been effective in managing metastatic bladder cancer, urinary bladder, and mediastinitis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine Hydrochloride With or Without WEE1 Inhibitor AZD1775 in Treating Patients With Previously Untreated Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery

2014. "Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine Hydrochloride With or Without WEE1 Inhibitor AZD1775 in Treating Patients With Previously Untreated Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02194829.