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An Open Label Phase I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Patients With Various Advanced or Metastatic Non-hematologic Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

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Trial Information

An Open Label Phase I Dose Finding Study of BI 853520 Administered Orally in a Continuous Dosing Schedule in Patients With Various Advanced or Metastatic Non-hematologic Malignancies

Inclusion Criteria


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 >= 18 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

After the first 28 days of treatment

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Canada: Health Canada

Study ID:

1300.2

NCT ID:

NCT01335269

Start Date:

July 2011

Completion Date:

October 2014

Related Keywords:

  • Neoplasms
  • Neoplasms

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