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This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours)

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ClinicalTrials.gov Identifier: NCT03604445
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI 905677 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905677. The MTD will be defined based on the frequency of patients experiencing Dose Limiting Toxicity (DLT)s during the MTD evaluation period, which is defined as the first cycle of treatment. Separate MTDs will be determined for dosing Schedule A and dosing Schedule B. Recruitment into Schedule B will start after the MTD of Schedule A is reached.

The secondary objective of the trial is:

- To determine the pharmacokinetic profile of BI 905677


Condition or disease Intervention/treatment Phase
Neoplasms Drug: BI 905677 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905677 Administered Intravenously in Patients With Advanced Solid Tumours
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: BI 905677
Schedule A: 3 week cycle (treatment every 3 weeks). Schedule B: 4 week cycle (treatment every 2 weeks). Recruitment into Schedule B will start after the MTD of Schedule A is reached.
Drug: BI 905677
Solution for infusion




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of BI 905677 [ Time Frame: Up to 4 weeks ]
  2. Number of patients experiencing adverse events (AEs) during the entire treatment period [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Cmax: maximum measured concentration of BI 905677 in serum after first infusion [ Time Frame: 24 hours ]
  2. AUC0-tz: area under the serum concentration-time curve over the time interval from 0 to the last measured time point (tz) [ Time Frame: 18 months ]


Information from the National Library of Medicine

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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

  • Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must have measurable or evaluable lesions (according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1).
  • Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted treatment options known to prolong survival for their disease.
  • Patient willing to undergo mandatory skin biopsy at the timepoints specified in the protocol.
  • Eastern Cooperative Oncology Group score of 0 or 1.
  • Adequate organ function defined as all of the following:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; haemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L without the use of hematopoietic growth factors within 4 weeks of start of study medication.
    • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.
    • Creatinine ≤ 1.5 x ULN. If creatinine is > 1.5 x ULN, patient is eligible if concurrent creatinine clearance ≥ 50 ml/min (measured or calculated by CKDEPI formula or Japanese version of CKD-EPI formula for Japanese patients).
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN
    • Alkaline Phosphatase < 5 x ULN
  • Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia and stable sensory neuropathy which must be ≤ CTCAE Grade 2).
  • At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.
  • Male or female patients. Women of childbearing potential (WOCBP) must only be included after a confirmed menstrual period within the past 4 weeks and a negative pregnancy test at screening. WOCBP with irregular menstruation may be included after two negative pregnancy tests during screening between 2 and 4 weeks apart. WOCBP and men who are able to father a child must be ready and able to use highly effective methods of birth control, per ICH M3 (R2), that result in a low failure rate of less than 1% per year when used consistently and correctly. These methods must be used during the study and for at least 6 months after the last dose of BI 905677. A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion criteria

  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening.
  • Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except;

    • effectively treated non-melanoma skin cancers
    • effectively treated carcinoma in situ of the cervix
    • effectively treated ductal carcinoma in situ
    • other effectively treated malignancy that is considered cured by local treatment
  • Osteoporosis ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
  • Chronic corticosteroid use
  • Osteoporotic compression fracture within 12 months prior to informed consent which is clinically significant in the opinion of the investigator.
  • 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.
  • Previous treatment in this trial.
  • Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication.
  • Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the safety and efficacy of the test drug.
  • Women who are pregnant, nursing, or who plan to become pregnant or nurse during the trial or within 6 months after the last dose of study treatment.
  • Active alcohol or drug abuse in the opinion of the investigator.
  • Patient unwilling or unable to comply with the protocol.
  • Presence or history of uncontrolled or symptomatic brain or subdural metastases, unless considered stable by the investigator and local therapy was completed. Inclusion of patients with newly identified brain metastasis/es at screening will be allowed if patients are asymptomatic.
  • Known history of human immunodeficiency virus (HIV) infection or an active hepatitis B or C infection which in the opinion of the investigator may interfere with participation in the trial.
  • History of severe hypersensitivity reactions to monoclonal antibodies.
  • History of allergy to kanamycin or similar class drugs (including streptomycin, gentamicin, amikacin, tobramycin and neomycin).

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): NCT03604445


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

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Heinz-Josef Lenz    +001 (323) 865-3955    lenz@usc.edu   
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Rona Yaeger    +001 (646) 888-5109    yaegerr@mskcc.org   
Japan
National Cancer Center Hospital East Recruiting
Chiba, Kashiwa, Japan, 277-8577
Contact: Toshihiko Doi    +81 4 71331111    tdoi@east.ncc.go.jp   
Netherlands
Erasmus MC Kanker Instituut Recruiting
Rotterdam, Netherlands, 3015 CN
Contact: Maja de Jonge    +31 10 7041733    m.dejonge@erasmusmc.nl   
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Guillermo Argilés    +34932746085    gargiles@vhio.net   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03604445     History of Changes
Other Study ID Numbers: 1401-0001
2017-002945-31 ( EudraCT Number )
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

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