What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine plus nab-paclitaxel (G/NP) and FOLFIRINOX, have notable side effects. G/NP often leads to neutropenia, fatigue, peripheral neuropathy, and gastrointestinal issues like nausea and diarrhea. FOLFIRINOX, which includes fluorouracil, leucovorin, irinotecan, and oxaliplatin, tends to cause more severe side effects, including neutropenia, thrombocytopenia, diarrhea, peripheral neuropathy, and fatigue. These side effects can significantly affect the patient's quality of life and require careful management.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapy regimens such as gemcitabine plus nab-paclitaxel and FOLFIRINOX. These combinations are commonly used for their efficacy in treating advanced stages of the disease. While Pamrevlumab, which targets connective tissue growth factor (CTGF), is still under investigation, it represents a novel approach in the treatment landscape. Other FDA-approved treatments include targeted therapies like erlotinib, which is used in combination with gemcitabine, and immunotherapy agents such as pembrolizumab for patients with specific genetic markers.

What other types of research exist?

Promising novel alternatives to Pamrevlumab for pancreatic cancer patients include: 1) Immunotherapy agents such as checkpoint inhibitors (e.g., pembrolizumab, nivolumab) which target PD-1/PD-L1 pathways. 2) Combination therapies involving chemotherapy agents like gemcitabine plus nab-paclitaxel or FOLFIRINOX. 3) Targeted therapies such as PARP inhibitors (e.g., olaparib) for patients with BRCA mutations. 4) Novel agents in clinical trials, such as those targeting KRAS mutations or other specific molecular targets.

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Chemotherapy

Pamrevlumab + Chemotherapy for Pancreatic Cancer (LAPIS Trial)

Phase 3

Waitlist Available

Research Sponsored by FibroGen

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 randomization until centrally-assessed progressive disease (pd), death, or first administration of anti-tumor treatment (other than study medication), whichever occurs first (assessed up to 6 years)

Awards & highlights

Summary

This trial is testing pamrevlumab with standard chemotherapy in patients with advanced pancreatic cancer that can't be surgically removed. The goal is to see if the new drug can help shrink tumors enough to make surgery possible.

Who is the study for?

Adults over 18 with locally advanced, unresectable pancreatic cancer can join this trial. They must have good organ function, no recent other cancers (except certain skin cancers), and not be on drugs affecting liver enzymes. Participants need to use effective contraception and cannot be pregnant or breastfeeding.

What is being tested?

The trial is testing the safety and effectiveness of a new drug called Pamrevlumab combined with chemotherapy (Gemcitabine plus Nab-paclitaxel or FOLFIRINOX) compared to placebo with the same chemotherapies in treating pancreatic cancer before surgery.

What are the potential side effects?

Possible side effects include reactions related to monoclonal antibodies like Pamrevlumab, as well as those associated with chemotherapy such as fatigue, nausea, low blood counts, peripheral neuropathy (nerve pain), and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization until centrally-assessed progressive disease (pd), death, or first administration of anti-tumor treatment (other than study medication), whichever occurs first (assessed up to 6 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization until centrally-assessed progressive disease (pd), death, or first administration of anti-tumor treatment (other than study medication), whichever occurs first (assessed up to 6 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization until centrally-assessed progressive disease (pd), death, or first administration of anti-tumor treatment (other than study medication), whichever occurs first (assessed up to 6 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Best Overall Objective Response Rate (ORR), as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment1 Intervention

Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX

Group II: Arm BPlacebo Group1 Intervention

Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX

2019

Completed Phase 3

~290

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include chemotherapy regimens like gemcitabine plus nab-paclitaxel and FOLFIRINOX. Gemcitabine inhibits DNA synthesis, while nab-paclitaxel disrupts microtubule function, both leading to cancer cell death. FOLFIRINOX combines leucovorin, fluorouracil, irinotecan, and oxaliplatin, which work synergistically to inhibit DNA replication and repair, causing cell death. Pamrevlumab, an investigational drug, inhibits connective tissue growth factor (CTGF), which is involved in tumor growth and metastasis. These treatments are crucial as they target the aggressive nature of pancreatic cancer, aiming to slow disease progression and improve patient outcomes.

Promising new therapies in advanced pancreatic adenocarcinomas.

Find a Location

Who is running the clinical trial?

FibroGenLead Sponsor

57 Previous Clinical Trials

15,023 Total Patients Enrolled

Media Library

FOLFIRINOX (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03941093 — Phase 3

Pancreatic Cancer Research Study Groups: Arm A, Arm B

Pancreatic Cancer Clinical Trial 2023: FOLFIRINOX Highlights & Side Effects. Trial Name: NCT03941093 — Phase 3

FOLFIRINOX (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03941093 — Phase 3

Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT03941093 — Phase 3

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