Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

An Open Phase I Repeated Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

NCT02211859•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
•Evaluable tumour deposits
•Age 18 years or older
•Life expectancy of at least six months
•Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
•Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
•Full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

Exclusion Criteria

•Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
•Pregnancy or breastfeeding
•Active infectious disease
•Known brain metastases
•Second malignancy requiring therapy
•Absolute neutrophil count less than 1500/mm3
•Platelet count less than 100 000/mm3
•Bilirubin greater than 1.5 mg/dl (\> 26 μmol/L)
•Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
•Serum creatinine greater than 1.5 mg/dl (\> 132 μmol/L)
+2 more criteria

Key Dates

Start Date

August 1, 2004

Primary Completion Date

December 1, 2007

Last Updated

December 20, 2024

Enrollment

ACTUAL participants

Conditions

Neoplasms

Interventions

BI 2536

DRUG

Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection

NCT07159659

Thoracic Neoplasms

View study

RECRUITINGPHASE2

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

NCT07169851

NauseaVomiting+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Inclusion Criteria

Exclusion Criteria

Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Skin Conductance for Predicting Spinal Anesthesia-Induced Hypotension in Geriatric Urologic Oncology Patients

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies