nab-paclitaxel for Adenocarcinoma

1
Effectiveness
2
Safety
Site ES34005, Lleida, Spain
Adenocarcinoma+4 More
nab-paclitaxel - Drug
Eligibility
18+
All Sexes
Eligible conditions
Adenocarcinoma

Study Summary

A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

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Eligible Conditions

  • Adenocarcinoma
  • Cancer of Pancreas
  • Malignant Neoplasm of Pancreas
  • Pancreatic Adenocarcinoma Metastatic
  • Pancreatic Metastatic Cancer
  • Pancreatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether nab-paclitaxel will improve 9 primary outcomes and 33 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of Up to 28 days.

Month 65
Change in CA (Cancer Antigen) 19-9
Up to 28 days
Dose Limiting Toxicities (DLT) - (safety lead in)
Up to 30 days
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
PK of Nab-P: Clearance (CL)
PK of Nab-P: Maximum Concentration (Cmax)
PK of Nab-P: Terminal Elimination Half-life (T1/2)
PK of Nab-P: Time of Maximum Concentration (Tmax)
PK of Nab-P: Volume of Distribution During the Terminal Phase (Vz)
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
PK of gemcitabine: Clearance (CL)
PK of gemcitabine: Maximum Concentration (Cmax)
PK of gemcitabine: Terminal Elimination Half-life (T1/2)
PK of gemcitabine: Time of Maximum Concentration (Tmax)
PK of gemcitabine: Volume of Distribution During the Terminal Phase (Vz)
PK of paclitaxel: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
PK of paclitaxel: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
PK of paclitaxel: Clearance (CL)
PK of paclitaxel: Maximum Concentration (Cmax)
PK of paclitaxel: Terminal Elimination Half-life (T1/2)
PK of paclitaxel: Time of Maximum Concentration (Tmax)
PK of paclitaxel: Volume of Distribution During the Terminal Phase (Vz)
Up to 65 months
Disease Control Rate (DCR)
Duration Of Response (DOR)
Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30)
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module (EORTC-QLQ-PAN-26)
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Change (PGIC) scale
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Severity (PGIS) Scale
Number of anti-drug antibody (ADA) Positive Participants
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
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Objective Response Rate (ORR)
Overall Survival (OS)
PK of zolbetuximab: Concentration Immediately Prior to Dosing (Ctrough)
Progression Free Survival (PFS)
Safety assessed by Adverse Events (AEs)
Safety assessed by incidence of serious adverse events (SAE)
Safety assessed by incidence of treatment emergent adverse events (TEAE)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

nab-paclitaxel + gemcitabine
zolbetuximab +nab-paclitaxel + gemcitabine

This trial requires 369 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nab-paclitaxel 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 2 and have already been tested with other people.

zolbetuximab +nab-paclitaxel + gemcitabineParticipants 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.
nab-paclitaxel + gemcitabineParticipants 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
Gemcitabine
FDA approved
Zolbetuximab
Not yet FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 65 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 65 months for reporting.

Closest Location

Midstate Medical Center - Meriden, CT

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:
A woman who is not of childbearing potential or agrees to follow contraceptive guidance for the duration of the study and for at least six months after the final study drug administration. show original
The female subject must not breastfeed for the duration of the study, and for six months following the final study drug administration. show original
A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration show original
Male participants with pregnant or breastfeeding partners must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration. show original
The male subject must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration show original
Subjects must have pancreatic cancer that has spread to other parts of their body (metastatic cancer) and have not been treated with chemotherapy before. show original
People who have received previous treatment with fluorouracil (5-FU) or GEM (a radiation sensitizer) are allowed to undergo radiation therapy show original
Female participants must not donate eggs starting at screening and throughout the study period, and for 6 months after the final study drug administration. show original
The subject agrees not to participate in any other studies that involve the use of a drug while they are receiving the drug in the present study. show original
The subject has been confirmed to have adenocarcinoma of the pancreas through a histological or cytological examination. show original

Patient Q&A Section

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

What is the latest research for adenocarcinoma?

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The best form of systemic therapy for patients with this type of cancer is debated in the scientific literature. Findings from a recent study of clinical trials evaluating the efficacy of different therapies must be considered in the management of patients with this type of cancer in routine medical practice, as well as in future trials regarding the treatment of unresectable disease.

Unverified Answer

What is adenocarcinoma?

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Adenocarcinoma typically consists of glandular structures with a mucus lining, and can spread in more limited ways than a carcinoma. There are many subtypes of adenocarcinoma and the terminology is always confusing. If adenocarcinoma is suspected, a biopsy is recommended, and a microscopic examination may discover a number of the potential subtypes.

Unverified Answer

What are common treatments for adenocarcinoma?

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Overall, there was a similar utilization of therapies across racial groups in these selected studies. The utilization of chemotherapy was higher in patients receiving adjuvant therapies, whereas the use of adjuvant endocrine therapy was higher in patients who had undergone a hysterectomy. Despite these differences in therapy utilization, survival was comparable across racial groups in these selected studies. A better understanding of the pharmacologic treatments for colon cancer should provide support for a better quality of care provided to patients with this disease.

Unverified Answer

What are the signs of adenocarcinoma?

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Most symptoms of adenocarcinoma of the oesophagus occur only in advanced disease or are non-specific. It is therefore difficult to identify clinically by signs or symptoms alone. The best method of diagnosis is usually by a flexible endoscope and biopsy, but the only definitive method is surgery.

Unverified Answer

What causes adenocarcinoma?

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Findings from a recent study of this investigation did not support a genetic component for adenocarcinoma in patients with acrolein-induced leukoplakia. Rather, they are consistent with a mechanical mechanism in which acrolein's cytotoxic action damages the crypt cells and then induces proliferation and transformation of acrolein-treated cells to adenocarcinoma. This is supported by the observation that no patient with acrolein-induced leukoplakia developed adenocarcinoma anywhere other than the area of leukoplakia.

Unverified Answer

Can adenocarcinoma be cured?

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Most adenocarcinomas can be cured. A cure can be achieved in about 80% of women and about 62% of men with early-stage disease. The chance of cure is enhanced if, among women, the disease has not metastasized (stage IVB) or the disease cannot spread through the circulatory system (stage IVC1). This is especially important if lymph nodes and/or the pelvis are involved. In women with disseminated disease, the chance of cure is still very low, even after the spread-out of the disease. For all patients, about 25% do, however, experience spontaneous disease regression.

Unverified Answer

How many people get adenocarcinoma a year in the United States?

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Adenocarcinoma cases occur more seldom in non-Hispanic whites than non-Hispanic blacks. The incidence of adenocarcinoma is increasing, especially among white men. Adenocarcinoma may be an underrecognized and important complication among black male smokers.

Unverified Answer

Is nab-paclitaxel typically used in combination with any other treatments?

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Given that nab-paclitaxel is used alone or in combination with other anticancer drugs in routine clinical practice, the most common combinations of drugs are carboplatin-paclitaxel, capecitabine-paclitaxel, nab-paclitaxel + gemcitabine, nab-paclitaxel + erlotinib, and nab-paclitaxel + sorafenib.

Unverified Answer

Has nab-paclitaxel proven to be more effective than a placebo?

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Nab-paclitaxel is efficacious in the treatment of patients with [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer) and is an important addition in the treatment of breast cancer and multiple myeloma. Findings from a recent study may be the largest single-center experience in examining the use of nab-paclitaxel for the treatment of taxane-refractory metastatic breast cancer. As a result of our study, nab-paclitaxel should be included in the routine chemotherapy of metastatic breast cancer patients.

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Does adenocarcinoma run in families?

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There is no association between any of the predisposing genes and familial adenocarcinoma of the colon. The genetic heterogeneity of colon cancer should be taken into account for molecular genetic studies on prognostic or therapeutic targets.

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What is nab-paclitaxel?

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nab-paclitaxel seems to be well tolerated in the treatment of patients with metastatic adenocarcinomas. These patients should be followed up for signs of toxicity because nab-paclitaxel is a new treatment approach with no confirmed long-term toxicity.

Unverified Answer

How serious can adenocarcinoma be?

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While adenocarcinoma is the most common cause of colorectal cancer in the Netherlands, the five-year cause-specific survival rate of this disease is much lower than that achieved in the majority of industrialized countries.

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