What is this study trying to find out about advanced cancer?

This study is evaluating how targeted anticancer drugs work when chosen based on specific molecular changes in tumors of patients with advanced cancer. Researchers aim to better understand the effectiveness and side effects of these drugs when standard treatments are no longer an option. The study is sponsored by The Netherlands Cancer Institute to improve access to personalized cancer therapies.

Who may be eligible for this advanced cancer clinical trial?

Adults 18 years or older with advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma who have exhausted standard treatment options may be eligible. Participants must have a tumor molecular profile showing actionable variants and acceptable organ function. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any out-of-pocket costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID02925234

Study to Improve Access to Approved Targeted Cancer Drugs for Adults With Advanced Cancers Having Specific Molecular Profiles

Led by The Netherlands Cancer Institute · Updated on 2024-01-24

1550

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the use of targeted anticancer drugs in patients with advanced cancer who have specific molecular changes in their tumors. This study aims to describe how well these targeted drugs work and their side effects when prescribed based on a tumors genetic or protein profile. It focuses on patients with advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma who have no standard treatment options left and have acceptable health status and organ function. Participants receive targeted cancer drugs selected from a list of approved therapies matched to their tumors molecular profile. A molecular tumor board and study coordinators help determine the best drug choice. Before treatment, patients provide a fresh tumor biopsy for genetic analysis. The study includes many drugs, including Panitumumab, Olaparib, Dabrafenib, and several others, some given alone or in combination, according to the tumor profile. Treatment eligibility and drug-specific criteria are confirmed before starting therapy. Throughout the study, participants are monitored for tumor response, disease stability, survival, and treatment side effects. Researchers collect data on tumor changes, progression-free survival, overall survival, and how long patients remain on treatment. Next generation sequencing on tumor samples provides additional biomarker information. The study continues to follow patients for up to one year after treatment to assess outcomes and safety.

CONDITIONS

Brief Title

The Drug Rediscovery Protocol (DRUP Trial)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults over 18 years with confirmed advanced or metastatic solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma with disease progression after standard treatment or no available standard treatment
For brain tumor patients, confirmed recurrent or new brain tumor with progression after prior therapy and stable or decreasing steroid use
ECOG performance status of 0 to 2
Acceptable organ function including specified blood counts, liver enzymes, and kidney function
Measurable disease by physical or imaging exams according to standard criteria
Results from a tumor genomic or protein expression test showing at least one actionable molecular variant
Tumor profile suitable for treatment with one of the approved targeted drugs in the study
Fresh frozen tumor biopsy obtained within 2 months before treatment for biomarker testing, with some exceptions for brain tumor patients and prior tissue samples
Ability and willingness to sign informed consent
Ability to swallow and tolerate oral medication for oral drugs
Agreement to use contraception during and for four months after study treatment for men and women of child-bearing potential

You will not qualify if you...

Ongoing treatment toxicity greater than grade 2 except hair loss
Receiving other anti-cancer treatments without required washout, except approved exceptions like androgen deprivation therapy for CRPC
Pregnancy or nursing
Active progressive brain metastases or unstable neurological status
For glioblastoma patients, restrictions on certain anti-convulsant drugs and recent radiotherapy
Significant heart conditions including uncontrolled angina, arrhythmias, or heart failure
Left ventricular ejection fraction below 40%
Stroke or heart attack within 3 months before starting treatment
Any other medical condition that could interfere with study participation or compliance as judged by the physician
Drug-specific inclusion and exclusion criteria may also apply and take precedence

Research Team

E.E. Voest, prof.

K. Verkerk, MD

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Study to Improve Access to Approved Targeted Cancer Drugs for Adults With Advanced Cancers Having Specific Molecular Profiles

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria