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Anti-metabolites

Gemcitabine for Pancreatic Cancer (TIGeR-PaC Trial)

Phase 3

Waitlist Available

Research Sponsored by RenovoRx

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

TIGeR-PaC Trial Summary

This trial is testing a new treatment for pancreatic cancer that has spread and cannot be removed with surgery.

Eligible Conditions

Locally Advanced Pancreatic Cancer

TIGeR-PaC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival

Secondary outcome measures

Frequency of neutropenia

Health Related Quality of Life

Neuropathy Assessment

+5 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

TIGeR-PaC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IA TherapyExperimental Treatment2 Interventions

IA Treatments with 1,000 mg/m2 gemcitabine administered through RenovoCath every other week for a maximum of 8 treatments for approximately 16 weeks.

Group II: IV TherapyActive Control2 Interventions

IV gemcitabine and nab-paclitaxel will be administered for 16 weeks on days 1, 8, and 15 of a 28 day cycle. Nab-paclitaxel will be administered intravenously following pre-medication at a dose of 125 mg/m2 over 30 minutes followed by an infusion of gemcitabine at a dose of 1000 mg/m2 over 30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

RenovoRxLead Sponsor

2 Previous Clinical Trials

45 Total Patients Enrolled

Michael J PishvaianStudy ChairJohns Hopkins Kimmel Cancer Center

Frequently Asked Questions

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

What are some indications that a doctor might prescribe Gemcitabine?

"Gemcitabine is a medication that is used to treat neoplasm metastasis. It can also be administered to treat a variety of other conditions including locally advanced non-small cell lung cancer, metastatic bladder cancer, urinary bladder."

Answered by AI

With how many different hospitals is this research being conducted?

"This clinical trial has 15 different recruitment sites, including Dartmouth-Hitchcock Medical Center in Lebanon, Medical University of South carolina - Hollings Cancer Center in Charleston, Sarasota Memorial Health Care System in Sarasota, and other locations."

Answered by AI

What are the odds of negative side effects from Gemcitabine?

"There is some evidence of efficacy and Gemcitabine has undergone multiple rounds of testing, so it has been given a safety score of 3."

Answered by AI

Is Gemcitabine a common medication tested in these kinds of studies?

"There are 1165 clinical trials involving Gemcitabine currently underway, with 329 of those in Phase 3. Many of these trials are based in Shanghai, but there are 59325 locations globally where these trials are taking place."

Answered by AI

Are there any open positions for study participants?

"That is correct, the information available on clinicaltrials.gov reveals that this trial is currently looking for patients. First posted on March 12th, 2018, and last updated February 23rd, 2022, the study needs to recruit 320 patients from 15 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

2018. "Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03257033.