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Completed

NCT Number: NCT01905111

A Study of BI 853520 in Japanese and Taiwanese Patients With Various Types of Advanced or Metastatic Cancer

The primary objective of this trial is to explore the safety and tolerability of BI 853520 monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese patients with advanced or metastatic solid tumours.

Secondary objective is collection of preliminary data on anti-tumour efficacy

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Key information

Conditions

Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1300.15.81001 Boehringer Ingelheim Investigational Site, Kashiwa-shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a confirmed diagnosis of advanced, measurable or evaluable, non-resectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months
  • Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
  • Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (Common Terminology Criteria for Adverse Events grade <2)
  • Age >= 20 years
  • Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation
  • Eastern Cooperative Oncology Group (ECOG), performance score 0-1

Exclusion criteria

  • Serious concomitant non-oncological disease/illness
  • Active/symptomatic brain metastases
  • Second malignancy
  • Pregnancy or breastfeeding
  • Women or men who are sexually active and unwilling to use a medically acceptable method of contraception.
  • Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication

Treatment and study plan

BI 853520

Drug

BI 853520 once daily in a dose escalation schedule

Primary outcomes

  1. Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient

    Time frame: After the first 28 days of treatment

Secondary outcomes

  1. Objective response rate

    Time frame: Every 8 weeks until end of study participation, assessed up to 12 months

  2. Disease control rate

    Time frame: Every 8 weeks until end of study participation, assessed up to 12 months

  3. Duration of disease control

    Time frame: Every 8 weeks until end of study participation, assessed up to 12 months

  4. Tumour shrinkage (in millimetre) defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of longest diameters of the same set of target lesions

    Time frame: Every 8 weeks until end of study participation, assessed up to 12 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open-label Phase I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Japanese and Taiwanese Patients With Various Advanced or Metastatic Solid Tumours

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 23, 2013
Registry last updated
Sep 4, 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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