CompletedPhase 1

Phase I Trial of BI 836845 for Various Solid Cancer

Taiwan61 participantsStarted 2011-07-19

Plain-language summary

This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) or the relevant biological dose (RBD) in the absence if a MTD of a new drug BI 836845 which blocks the insulin-like growth factor (IGF) pathway believed to be involved in cancer growth. BI 836845 will be administered for the very first time into cancer patients. The study will also look at the overall safety of the drug, and examine the drug levels in the body at specific timepoints during the trial (pharmacokinetic profile); the effect the drug may have on tumours will also be examined (pharmacodynamics).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and / or metastatic solid cancer, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment.
✓. Patients should have evaluable disease, or at least one measurable lesion according to RECIST criteria version 1.1.
✓. Age 18 years or older.
✓. Life expectancy of at least 3 months in the opinion of the investigator.
✓. Written informed consent that is consistent with ICH-GCP guidelines and local legislation.
✓. Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2.
✓. Patients must have recovered from any previous surgery and have had no major surgery within the last 28 days prior to start of trial medication in the opinion of the investigator.
✓. Cardiac left ventricular function with resting ejection fraction \> 50% as determined by ECHO or MUGA.

Exclusion criteria

What they're measuring

Part 1: Maximum Tolerated Dose (MTD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase.

Timeframe: During the first course of treatment, up to 21 days

Part 1: Number of Patients With Dose Limiting Toxicities (DLTs) During the Maximum Tolerated Dose (MTD) Evaluation Period

Timeframe: During the first course of treatment, up to 21 days

Trial details

NCT IDNCT01403974

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07-08

Results submitted2025-05-14

View on ClinicalTrials.gov More Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and / or metastatic solid cancer, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment.
✓. Patients should have evaluable disease, or at least one measurable lesion according to RECIST criteria version 1.1.
✓. Age 18 years or older.
✓. Life expectancy of at least 3 months in the opinion of the investigator.
✓. Written informed consent that is consistent with ICH-GCP guidelines and local legislation.
✓. Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2.
✓. Patients must have recovered from any previous surgery and have had no major surgery within the last 28 days prior to start of trial medication in the opinion of the investigator.
✓. Cardiac left ventricular function with resting ejection fraction \> 50% as determined by ECHO or MUGA.

Exclusion criteria

What they're measuring

Part 1: Maximum Tolerated Dose (MTD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase.

Timeframe: During the first course of treatment, up to 21 days

Part 1: Number of Patients With Dose Limiting Toxicities (DLTs) During the Maximum Tolerated Dose (MTD) Evaluation Period

Timeframe: During the first course of treatment, up to 21 days