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JOURNAL ONKOLOGIE – STUDIE

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)

Rekrutierend

NCT-Nummer:
NCT03449381

Studienbeginn:
Mai 2018

Letztes Update:
30.04.2024

Wirkstoff:
BI 907828

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Boehringer Ingelheim

Collaborator:
-

Kontakt

Additional US locations available on demand. Please contact for options.
Kontakt:
Phone: 1-800-243-0127
» Kontaktdaten anzeigen

Studienlocations
(3 von 29)

Universitätsmedizin Göttingen, Georg-August-Universität
37075 Göttingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Universitätsklinikum Köln (AöR)
50937 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Viszeralonkologisches Zentrum Universitätsklinikum Tübingen
Hoppe-Seyler-Straße 3
72076 Tübingen
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen
Memorial Sloan-Kettering Cancer Center
10065 New York
United StatesAbgeschlossen» Google-Maps
The University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 833-602-2368
E-Mail: unitedstates@bitrialsupport.com» Ansprechpartner anzeigen
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
60-693 Poznan
PolandRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 008001218830
E-Mail: polska@bitrialsupport.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

This study is open to adults with different types of advanced cancer (solid tumors). The

purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the

participants can tolerate. The most suitable dose is used in the second part to find out

whether brigimadlin makes tumors shrink.

In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called

MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet.

Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every

4 weeks.

The participants are in the study for as long as they benefit from and can tolerate

treatment. The doctors regularly check the participants' general health during the study.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Provision of signed and dated, written informed consent form ICF in accordance with

ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or

analyses.

- Pathologically documented, advanced solid tumors.

- Patients fulfilling one or more of the following criteria:

- Radiologically documented disease progression or relapse

- Patients who are not eligible to receive standard of care treatments, and for

whom no proven treatments exist.

- Patients with MDM2 amplified sarcomas who require first line treatment (for Ph

Ib/dose expansion - Cohort 1 only).

- Patients with MDM2 amplified sarcomas may fulfil any one of the above three criteria

to be considered eligible.

- Phase Ia (dose escalation) only:

- Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status,

and regardless of MDM2 amplification status, at the time of study entry.

- Phase Ib (expansion phase) only:

- Cohort 1: TP53 wt and MDM2-amplified sarcoma with advanced/metastatic disease at any

line of therapy. If TP53 status is not available during screening, the patient may be

included with unknown TP53 status if a tissue sample is submitted for central

laboratory assessment. If TP53 status cannot be evaluated, the patient may be included

if agreed between the Investigator and Sponsor.

- Cohort 2: TP53 wt and MDM2- amplified NSCLC, urothelial, gastric, biliary tract

(including cholangiocarcinoma, intra- and extrahepatic biliary tree, gall blander and

ampulla of vater) or pancreatic solidPDAC tumors who have had at least one previous

line of therapy for advanced/metastatic disease. If TP53 status cannot be evaluated

the patient may be included if agreed between the Investigator and Sponsor

- Phase Ia (dose escalation) only:

- Patient with either measurable or non-measurable disease.

- Non-evaluable disease allowed.

- Phase Ib (expansion phase) only:

- At least one target lesion that can be accurately measured per RECIST v.1.1.

- Phase Ia:

- Patient must be willing to undergo blood sampling for PK, pharmacodynamic, biomarker,

and PGx analyses.

- Phase Ib:

- Patient must be willing to undergo tumor biopsy sampling for pharmacodynamic analyses

and blood sampling for PK, pharmacodynamics, and biomarker analyses.

- Willingness to provide a fresh tumor tissue sample obtained after relapse/ progression

during or after prior therapy. In case a fresh biopsy cannot be obtained (e.g.

inaccessible lesions or patient safety concern), an archived specimen, collected

before screening within 12 months of enrollment, may be submitted. If these

requirements cannot be met, then the patient may be allowed to enter the study at

Sponsor discretion, after agreement between the Investigator and Sponsor.

- Further inclusion criteria apply

Exclusion Criteria:

- Previous administration of BI 907828 (brigimadlin) or any other MDM2-p53 or MDMX

(MDM4)-p53 antagonist.

- Known TP53 mutant tumor.

- Symptomatic metastases from non-brain tumors. Note: Patients with previously treated

brain metastases may participate provided they are stable, without evidence of

progression by imaging (using the identical imaging modality for each assessment,

either MRI or computed tomography (CT) scan), for at least four weeks prior to the

first dose of trial treatment, and any neurologic symptoms have returned to baseline;

have no evidence of new or enlarging brain metastases. Patients on corticosteroids

must have a stable dose for at least 5 days prior to baseline MRI.

- Patients with history of bleeding diathesis.

- Major surgery (major according to the Investigator's assessment) performed within 12

weeks prior to start of study treatment, or planned within 12 months after screening

(e.g. hip replacement).

- Any other documented active or suspected malignancy or history of malignancy within 3

years prior to screening, except appropriately treated basal cell carcinoma of the

skin or in situ carcinoma of uterine cervix, or other local tumors considered cured by

local treatment.

- Patients who must or wish to continue the intake of restricted medications or any drug

considered likely to interfere with the safe conduct of the trial.

- Further exclusion criteria apply.

Studien-Rationale

Primary outcome:

1. Phase Ia- Maximum tolerated dose (MTD) based on number of patients with dose limiting toxicities (DLTs) during first treatment cycle (Time Frame - Up to 28 days)

2. Phase Ib - Progression-free survival (Time Frame - Up to 24 months)

3. Phase Ia - Number of patients with DLTs during first treatment cycle (21 days, Arm A; 28 days, Arm B) (Time Frame - Up to 28 days)

4. Phase Ib - Number of patients with DLTs during the first treatment cycle (Time Frame - Up to 28 days)

Secondary outcome:

1. Phase Ia - Cmax: Maximum measured concentration of BI 907828 in plasma (Time Frame - Up to 24 months)

2. Phase Ia - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (Time Frame - Up to 24 months)

3. Phase Ib - Objective response (Time Frame - Up to 24 months)

4. Phase Ib - Overall survival (Time Frame - Up to 24 months)

5. Phase Ib - Number of patients with Grade ≥3 treatment-related adverse events observed during the entire treatment period (Time Frame - Up to 24 months)

6. Phase Ib - Cmax: Maximum measured concentration of BI 907828 in plasma (Time Frame - Up to 24 months)

7. Phase Ib - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (Time Frame - Up to 24 months)

Studien-Arme

  • Experimental: Dose Escalation
  • Experimental: Dose Expansion

Geprüfte Regime

  • BI 907828 (brigimadlin):
    Film-coated tablet

Quelle: ClinicalTrials.gov


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