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MAK683 for Diffuse Large B-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)

Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by RECIST 1.1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study Summary

This trial is testing a new drug to see what dose is safe and how well it works against various types of cancer.

Who is the study for?

This trial is for adults with advanced cancers like Diffuse Large B-Cell Lymphoma or solid tumors without standard treatment options left. Participants should be fairly active and able to care for themselves (ECOG 0-2) and have measurable disease. They can't join if they've had certain recent cancer treatments, unstable brain involvement, a prior stem cell transplant, or blood, liver, and kidney values outside specific ranges.Check my eligibility

What is being tested?

The study tests MAK683's safety and effectiveness in treating advanced malignancies. It aims to find the highest dose patients can tolerate without severe side effects (MTD) and suggest a phase 2 dose (RP2D), while also studying how the body processes the drug.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects of MAK683 may include typical reactions seen with cancer therapies such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies, liver function alterations, and possibly others based on its mechanism of action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My large B cell lymphoma has returned or didn't respond to treatment, and it can be measured.

Select...

My cancer has spread or returned and can be measured by scans.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 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

Incidence of dose limiting toxicities (DLTs)

Safety and tolerability

Secondary outcome measures

Area Under the Plasma Concentration (AUC) Time Curve of MAK683

Best Overall Response (BOR)

Duration of overall response (DOR)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase I - AllExperimental Treatment1 Intervention

advanced stage (relapsed/refractory or recurrent/metastatic) malignancy limited to the following malignancies; DLBCL, nasopharyngeal carcinoma, gastric cancer, ovarian cancer, prostate cancer and sarcoma.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,214 Total Patients Enrolled

Media Library

Diffuse Large B-Cell Lymphoma Clinical Trial 2023: MAK683 Highlights & Side Effects. Trial Name: NCT02900651 — Phase 1

MAK683 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02900651 — Phase 1

Frequently Asked Questions

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

Are participants being admitted to this research endeavor?

"Clinicaltrials.gov discloses that this medical trial is no longer actively accepting patients; the study was initially posted on October 3rd 2016 and last updated November 29th 2022. Nevertheless, 363 other clinical trials are currently seeking out participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

2016. "Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02900651.