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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03449381
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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 the participants can tolerate. The most suitable dose is used in the second part to find out whether BI 907828 makes tumors shrink.

In this study, BI 907828 is given to humans for the first time. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. BI 907828 is taken as a tablet. Participants either take a dose of BI 907828 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.


Condition or disease Intervention/treatment Phase
Neoplasms Drug: BI 907828 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study of BI 907828 in Patients With Advanced or Metastatic Solid Tumors
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : April 30, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation Drug: BI 907828
Film-coated tablet
Experimental: Dose Expansion Drug: BI 907828
Film-coated tablet


Outcome Measures
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Primary Outcome Measures :
  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 Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449381


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06511
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Boehringer Ingelheim    080049616    belgique@bitrialsupport.com   
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Boehringer Ingelheim    18336022346    canada@bitrialsupport.com   
Germany
Helios Klinikum Berlin-Buch Recruiting
Berlin, Germany, 13125
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsklinikum Köln (AöR) Recruiting
Köln, Germany, 50937
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Japan
National Cancer Center Hospital Recruiting
Tokyo, Chuo-ku, Japan, 104-0045
Contact: Boehringer Ingelheim    0120201230    nippon@bitrialsupport.com   
Poland
MED POLONIA SP Z O O, Clinical Trials Department,Poznan Recruiting
Poznan, Poland, 60-693
Contact: Boehringer Ingelheim    008001218830    polska@bitrialsupport.com   
Oncology Center-Maria Sklodowska-Curie Institute Recruiting
Warsaw, Poland, 02-034
Contact: Boehringer Ingelheim    008001218830    polska@bitrialsupport.com   
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03449381    
Other Study ID Numbers: 1403-0001
2017-003210-95 ( EudraCT Number )
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No