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Anti-metabolites

Zolbetuximab + Chemotherapy for Pancreatic Cancer

Phase 2
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 65 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment and will measure how well it works, how long patients live, and how safe it is.

Who is the study for?
This trial is for adults with metastatic pancreatic adenocarcinoma that tests positive for CLDN18.2 and haven't had chemotherapy before. They should have a life expectancy of at least 12 weeks, be able to follow contraceptive guidelines, and not be pregnant or breastfeeding. People who've had certain recent treatments or surgeries, active infections, other cancers needing treatment, severe allergies to study drugs' components, or specific heart conditions can't join.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of a drug called zolbetuximab combined with Nab-Paclitaxel and Gemcitabine as the first line of treatment. It aims to confirm the best dose for phase 2 trials, measure how long patients live while on this treatment, monitor side effects, check how their bodies process the drugs (pharmacokinetics), and assess any changes in their quality of life.See study design
What are the potential side effects?
Possible side effects include reactions related to zolbetuximab infusion such as fever or chills; blood disorders like low white cell counts increasing infection risk; fatigue; digestive issues from nausea to diarrhea; potential liver enzyme changes; nerve damage causing numbness or tingling; allergic reactions; and possibly others not listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured and it's either outside the area treated with radiation or has grown after radiation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I agree not to breastfeed during and for 6 months after the study.
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I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.
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I have had fluorouracil or GEM with radiation therapy.
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My cancer returned or got worse 6 months after finishing my last cancer prevention treatment.
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My tumor shows high CLDN18.2 expression.
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My pancreatic cancer has spread and I haven't had chemotherapy.
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I will not donate sperm during or for 6 months after the study.
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My cancer is a type of pancreatic cancer called adenocarcinoma.
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I will not donate eggs during and for 6 months after the study.
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I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines for 6 months after the study.
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My condition did not worsen after treatment with Nab-P and GEM.
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My condition did not worsen after treatment with Nab-P and GEM.
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My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).
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I am a man who will use birth control during and for 6 months after the study.
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My liver function tests are within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 65 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 65 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
Dose Limiting Toxicities (DLT) - (safety lead in)
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
+6 more
Secondary outcome measures
Change in CA (Cancer Antigen) 19-9
Disease Control Rate (DCR)
Duration Of Response (DOR)
+23 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: zolbetuximab +nab-paclitaxel + gemcitabineExperimental Treatment3 Interventions
Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
Group II: nab-paclitaxel + gemcitabineActive Control2 Interventions
Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
zolbetuximab
2019
Completed Phase 2
~270
nab-paclitaxel
2008
Completed Phase 4
~1330
gemcitabine
2013
Completed Phase 3
~3530

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,693 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development
2,770 Previous Clinical Trials
8,061,597 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03816163 — Phase 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03816163 — Phase 2
Pancreatic Cancer Research Study Groups: zolbetuximab +nab-paclitaxel + gemcitabine, nab-paclitaxel + gemcitabine
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT03816163 — Phase 2

Frequently Asked Questions

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

What outcomes is this trial hoping to achieve?

"According to Astellas Pharma Global Development, Inc., the primary outcome for this trial will be Safety determined by Serious Adverse Events (SAE) over an up to 65 month time-frame. Additionally, secondary objectives involve measuring Objective Response Rate (ORR), Paclitaxel's Time of Maximum Concentration (Tmax), and Area Under the Concentration-time Curve from Time of Dosing Until Last Measurable Concentration (AUClast)."

Answered by AI

Have prior studies demonstrated the efficacy of nab-paclitaxel?

"The City of Hope Comprehensive Cancer Center initiated research on nab-paclitaxel in 1997, and a total of 1861 trials have been completed. Currently, there are 1116 existing medical studies being conducted at various locations around Olympia, Washington."

Answered by AI

What adverse effects are associated with the use of nab-paclitaxel?

"There is some evidence for nab-paclitaxel's safety, so it was rated a 2. However, there is yet to be any clinical data demonstrating its efficacy."

Answered by AI

Is enrollment in this clinical trial still possible?

"Affirmative. The data hosted on clinicaltrials.gov reveals that this research endeavour, which was initially advertised on March 15th 2019, is actively seeking participants. A total of 369 patients need to be recruited from 16 distinct healthcare facilities."

Answered by AI

How widely is this clinical trial distributed among hospitals in the state?

"Currently, the research is enrolling participants at 16 sites spread across multiple states. To reduce travel needs, those interested in joining should select a clinic closest to their current location from Olympia, Salt Lake City and Meriden among other cities."

Answered by AI

What are the applications of nab-paclitaxel in medical care?

"nab-paclitaxel is commonly prescribed to help reduce the spread of malignant neoplasms. This medication can also be useful in treating cases such as locally advanced non-small cell lung cancer, metastatic bladder cancer, and urinary tract cancers."

Answered by AI

What is the capacity of this experiment with regards to participant numbers?

"Astellas Pharma Global Development, Inc. is sponsoring this trial with the goal of enrolling 369 participants that meet the criteria specified in their protocols. Vista Oncology (Olympia, Washington) and Utah Cancer Specialists (Salt Lake City, Utah) are two centres where data collection will take place."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan-Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

How long do the screening visit takes?
PatientReceived no prior treatments

Why did patients apply to this trial?

I was diagnosed with Pancreatic Cancer(Neuro Endocrine Carcinoma) with Mets in both lobes of liver few months back(April-2023) during routine checkup, Took 6 chemo cycles(Carboplatin + Etoposide) which completed in July2023 and taking Durvalumab Immunotherapy in parallel - Took 7 cycle of Immuno till today & still continuing. No physical or psychological problems. Perfectly fine to travel anywhere for treatment & trial and I hold a valid US visa also if travelling to hospital is required. Detailed Summary - > Patient Summary - > My name is Ankit Dubey, Male 39, residing in India, willing to travel for treatment at your centre. > > Let me give you the background - Mar-Apr 2023, during routine checkup, I was diagnosed with Pancreatic cancer in Lucknow, INDIA with Metastasis spread across both lobes of liver ( I guess, it's considered as stage 4 cancer). > > Next day I travelled to Tata Memorial hospital, Mumbai INDIA where they repeated all tests, including CT scan & BIOPSY. > > Since bilrubin was increasing and BIOPSY report was not finalized so they gave 1st round of Chemo on 26th March (only Carboplatin-5AUC) to control the disease/bilirubin since bilrubin was increased to 6 from 4 in 4days and came back to 4 in 2 days just after 1st small dose of chemo. > > In hystopathology/ biopsy report - they identified it as Neuroendocrine carcinoma (high grade) and then gave another round of full chemo(Carboplatin + Etoposide) on 11,12 &13th April (after around 2weeks interval from 1st small chemo and prescribed 4 more cycles of full chemo(Carboplatin + Etoposide) cycle at interval of every 21 days then after. > > Did PetSCAN just before the 2nd cycle of full Chemo and found that Pancreatic Tumor was reduced from 6cm dia to around 1.5cm and METS in liver also shrunken significantly. (Initial CT & Pet SCAN report attached.
PatientReceived 1 prior treatment
~34 spots leftby Sep 2024