Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-12

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pharmacoscopy refers to an ex vivo real-time drug sensitivity profiling platform that has been shown to be of value in the treatment of leukemia (Snijder et al. 2017) (Kornauth et al. 2022) and may help to identify novel treatment opportunities for brain tumors as well (Lee et al. 2022). The rationale for pharmacoscopy-based drug sensitivity testing on real-time patient biopsies or surgery material is multiple: measuring drug response and sensitivity directly in real-time patient material, overcomes the problem of limited molecular biomarkers for established targeted therapeutic options and can identify effective drugs even for non-targeted therapies such as chemotherapy. It can also identify hitherto unknown specific vulnerabilities of cancer cells. Furthermore, testing directly on patient material overcomes the limitations of patient-derived cell cultures, organoids, and patient xenografts, as their prolonged culture times risk cellular adaptations and clonal selection that alter drug sensitivity. Pharmacoscopy maintains the tumor cell composition, including bystander cells or tumor microenvironment, and limits cell culture to max 48 hours. Furthermore, pharmacoscopy measures drug responses on a single-cell and on a high-content level, uniquely allowing to measure the drug sensitivity of tumor cells, and allowing to compare it to the drug cytotoxicity on healthy cells from the same patient. This relative readout has previously been shown to be essential for the correct prediction of a clinical response in haematological malignancies (Snijder et al. 2017) (Kornauth et al. 2022).

The aim of this study is to generate preliminary data regarding superiority of the personalized pharmacoscopy-guided approach compared to a standard non-pharmacoscopy-guided approach, in patients with brain metastases with an indication for surgery, and limited therapeutic systemic options according to the treating physician.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients

NCT03330990

Advanced Solid Tumor

COMPLETED PHASE1

The ROAD 2.0 to Sustainable Medication Use: Redispensing Unused Oral Anticancer Drugs

NCT06566560

Cancer Oncology Pharmacy +1 more

RECRUITING NA

Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer

NCT02876640

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 +6 more

TERMINATED PHASE1

The Drug Rediscovery Protocol (DRUP Trial)

NCT02925234

Cancer Tumors Neoplasm +1 more

RECRUITING PHASE2

A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833

NCT00001302

Breast Cancer Kidney Neoplasm Lymphoma +2 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Metastases Brain Metastases, Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase II interventional randomized non-comparative clinical study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: experimental arm, Pharmacoscopy-guided treatment

Arm 1 (experimental arm): Pharmacoscopy-guided treatment will be prescribed by the investigator according to the results of the analysis (relevant on-target effect) and per drug prescription guidelines.

Group Type EXPERIMENTAL

Pharmacoscopy 1.0

Intervention Type DEVICE

Pharmacoscopy is currently an academically developed platform. The study is designed to investigate the clinical performance of this academic platform. In the interventional arm, the best candidate agent defined by pharmascopy will be considered to guide the therapeutic decision for each patient.

Arm 2: control arm

For patients randomized to the control arm, no pharmacoscopy analysis will be performed.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

The next systemic treatment after surgery will be discussed, with the investigator and at the tumor board, considering also standard histopathological and molecular analysis, including next generation sequencing, molecular profiling analysis and previous treatments received

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pharmacoscopy 1.0

Pharmacoscopy is currently an academically developed platform. The study is designed to investigate the clinical performance of this academic platform. In the interventional arm, the best candidate agent defined by pharmascopy will be considered to guide the therapeutic decision for each patient.

Intervention Type DEVICE

Control

The next systemic treatment after surgery will be discussed, with the investigator and at the tumor board, considering also standard histopathological and molecular analysis, including next generation sequencing, molecular profiling analysis and previous treatments received

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must be 18 years or older on the day of signing the informed consent, female or male.
* Patients must have a Karnofsky performance status of 60 or more
* Patients must have limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.
* Patients with a tumor with a targetable oncogenic driver mutation should have already been treated with a targeted agent and options must have been exhausted.
* Patients must have a clinical indication for surgery for probable brain metastasis
* Patients will be considered eligible for the study only if the diagnosis of brain metastasis has been histologically confirmed on the sample obtained during the surgery performed after signing the informed consent form for the trial.
* Any type of primary cancer is allowed: breast cancer, lung cancer, melanoma, other cancers. Patients may have several primary cancers.
* Patients must have adequate bone marrow, renal and hepatic function documented at screening before surgery
* Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test
* Patients must have the ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
* Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.

Exclusion Criteria

* Patients with rapidly progressive systemic disease
* Patients with inability to undergo brain MRI evaluation.
* Patients with progressive parenchymal brain metastases with an indication for requiring whole brain radiotherapy after surgery. Focal brain radiotherapy after surgery is allowed.
* Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.
* Intention to become pregnant during the course of the study.
* Female who are pregnant.
* Female who are breastfeeding and who do not agree to discontinue nursing prior to the first treatment initiated during the study.
* Sexually active males and females of childbearing potential who are not willing to use an effective contraceptive method during the study. Male participants who do not agree not to donate sperm.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No