What side effects are associated with this type of intervention?

Common treatments for cancer, particularly those targeting specific pathways like MAPK inhibitors, often have a range of side effects. These can include gastrointestinal issues (e.g., diarrhea, nausea), fatigue, skin reactions (e.g., rash), and hematologic toxicities (e.g., anemia, neutropenia). Additionally, targeted therapies may cause specific adverse events related to the pathway being inhibited, such as hypertension or cardiac events. It's important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several drugs targeting the MAPK pathway for cancer treatment. Notable examples include vemurafenib and dabrafenib, which are BRAF inhibitors used in the treatment of melanoma with BRAF mutations. These drugs inhibit the MAPK pathway, which is crucial for cell division and survival in certain cancers. Additionally, combinations like vemurafenib plus rituximab have shown efficacy in treating relapsed or refractory hairy cell leukemia. These approvals highlight the therapeutic potential of targeting the MAPK pathway in various cancers.

What other types of research exist?

Promising alternatives to JZP815 for cancer patients include: 1) Abemaciclib, a CDK4/6 inhibitor, which has shown good tolerance and preliminary antitumor activity in various populations. 2) Ibrutinib, particularly effective in cancers with specific mutations like MYD88L265P. 3) Surufatinib, which has demonstrated significant improvement in progression-free survival in neuroendocrine tumors. 4) Pembrolizumab, a PD-1 inhibitor, which has shown durable responses in various cancers including non-small cell lung cancer and sarcomas.

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MAPK Pathway Inhibitor

JZP815 for Cancer

Phase 1

Recruiting

Research Sponsored by Jazz Pharmaceuticals

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 mtd determination cohorts, cycle 1 days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on cycle 1 day 1; others, cycle 1 days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing JZP815, a new drug, in patients with advanced or metastatic solid tumors that have specific genetic changes. The drug works by blocking signals that promote cancer growth.

Who is the study for?

Adults with advanced or metastatic solid tumors that have changes in the MAPK pathway can join this trial if they've tried all standard treatments without success, are not pregnant or breastfeeding, agree to use effective contraception, and have a life expectancy of at least 12 weeks. They must be able to undergo tumor biopsies and have good organ function.

What is being tested?

The study is testing JZP815 oral capsules for safety, proper dosing levels, and initial effectiveness against tumors. It's an early-phase trial (phase 1) focusing on patients whose cancers involve alterations in the MAPK pathway.

What are the potential side effects?

While specific side effects of JZP815 are not listed here, phase 1 trials typically monitor for any adverse reactions including nausea, fatigue, allergic reactions, blood count changes or other unexpected health issues related to the new medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mtd determination cohorts, cycle 1 days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on cycle 1 day 1; others, cycle 1 days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mtd determination cohorts, cycle 1 days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on cycle 1 day 1; others, cycle 1 days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and mtd determination cohorts, cycle 1 days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on cycle 1 day 1; others, cycle 1 days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP815 and its Metabolites (Part A)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion (Part B): JZP815Experimental Treatment1 Intervention

Participants with advanced or metastatic solid tumors who will receive JZP815 at the RP2D established in Dose Exploration (Part A).

Group II: Dose Exploration (Part A): JZP815Experimental Treatment1 Intervention

Participants will receive JZP815 with a starting dose of 20 mg twice daily (BID).

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

Cancer treatments often target specific molecular pathways that are crucial for tumor growth and survival. MAPK pathway inhibitors, like the investigational drug JZP815, block the mitogen-activated protein kinase pathway, which is involved in cell division and proliferation. By inhibiting this pathway, these drugs can slow down or stop the growth of cancer cells. This is particularly important for patients with tumors harboring MAPK pathway alterations, as it offers a targeted approach that can be more effective and potentially less toxic than traditional chemotherapy. Other common treatments include chemotherapy, which kills rapidly dividing cells, and immunotherapy, which boosts the body's immune system to fight cancer. Each of these treatments works through different mechanisms, providing multiple strategies to combat cancer and improve patient outcomes.

Prostanoid Signaling in Cancers: Expression and Regulation Patterns of Enzymes and Receptors.Overcoming therapeutic resistance in malignant gliomas: current practices and future directions.