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Completed

NCT Number: NCT02211872

BI 2536 BS in Patients With Advanced Solid Tumours and Repeated Administration in Patients With Clinical Benefit

The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI 2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of safety, efficacy, and pharmacokinetics of BI 2536 BS

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who had failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment
  • Evaluable tumour deposits
  • Age of 18 years or older
  • Life expectancy of at least 6 months
  • Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
  • Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ≤ 2
  • And 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 trial 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, international system of units (SI) equivalent)
  • 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, SI unit equivalent)
  • Sexually active women and men who are unwilling to use a medically acceptable method of contraception
  • Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
  • Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial
  • Patients unable to comply with the trial protocol
  • Or active alcohol or drug abuse

Treatment and study plan

BI 2536 BS, intravenous

Drug

Primary outcomes

  1. Maximum tolerated dose (MTD) for a single dose of BI 2536 BS

    Time frame: Up to 16 weeks

  2. MTD for single doses of BI 2536 BS on 3 consecutive days

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Assessment of objective treatment response by tumour measurements

    Time frame: Up to 1 year

    Evaluated according to the response evaluation criteria in solid tumors (RECIST)

  2. Number of patients with adverse events

    Time frame: Up to 1 year

  3. Maximum concentration of BI 2536 BS analyte in plasma (Cmax)

    Time frame: Pre-dose, up to 216 hours after drug administration

  4. Time from dosing to maximum concentration of BI 2536 BS in plasma (tmax)

    Time frame: Pre-dose, up to 216 hours after drug administration

  5. Area under the concentration-time curve of BI 2536 BS in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Pre-dose, up to 216 hours after drug administration

  6. Percentage of the AUC0-∞ that is obtained by extrapolation (%AUC0-tz)

    Time frame: Pre-dose, up to 216 hours after drug administration

  7. Terminal rate constant in plasma (λz)

    Time frame: Pre-dose, up to 216 hours after drug administration

  8. Terminal half-life of BI 2536 BS in plasma (t1/2)

    Time frame: Pre-dose, up to 216 hours after drug administration

  9. Mean residence time of BI 2536 BS in the body after intravenous administration (MRT)

    Time frame: Pre-dose, up to 216 hours after drug administration

  10. Total clearance of BI 2536 BS in the plasma after intravascular administration (CL)

    Time frame: Pre-dose, up to 216 hours after drug administration

  11. Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz)

    Time frame: Pre-dose, up to 216 hours after drug administration

  12. Apparent volume of distribution at steady state following intravascular administration (Vss)

    Time frame: Pre-dose, up to 216 hours after drug administration

  13. Amount of BI 2536 BS that is eliminated in urine from the time point 0 to time point 24/48 (Ae0-24/48)

    Time frame: Pre-dose, up to 48 hours after drug administration

  14. Fraction of analyte eliminated in urine from time point 0 to time point 24/48 (fe0-24/48)

    Time frame: Pre-dose, up to 48 hours after drug administration

  15. Renal clearance of BI 2536 BS from the time point 0 to time point 24/48 (CLR,0-24/48)

    Time frame: Pre-dose, up to 48 hours afterdrug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
First posted
Aug 8, 2014
Registry last updated
Aug 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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