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Monoclonal Antibodies

BI 836845 for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective against prostate cancer. The trial has three parts: first they test how well the drug works and how safe it is, then they test it on people who are already taking another prostate cancer drug, and finally they compare the new drug to the other prostate cancer drug.

Eligible Conditions
  • Castration-resistant Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (phase Ib escalation)
Number of patients with dose limiting toxicities (phase Ib escalation)
Prostate Surface Antigen (PSA) response - defined as a decline in PSA value >50% (which is confirmed by a second value 3 to 4 weeks apart) (phase Ib expansion)
+1 more
Secondary outcome measures
CTC response-CTC reduction compared to baseline for at least one time point after treatment start assessed by maximum change in CTC counts compared to baseline that occurs at any point after treatment start (phase II)
Therapeutic procedure
Changes in circulating tumour cells (CTC) response - CTC reduction compared to baseline for at least one time point after treatment defined as CTC decline from, equal to, or more than, 5 to <5 cells per 7.5ml blood (phase Ib expansion)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BI 836845 & EnzalutamideExperimental Treatment2 Interventions
Group II: EnzalutamideActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
BI 836845
2011
Completed Phase 1
~450

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,494 Previous Clinical Trials
11,338,858 Total Patients Enrolled
1 Trials studying Prostate Cancer
27 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for prospective participants in this experiment?

"Unfortunately, recruitment has ended for this trial as the last update was on November 15th 2022. However, if you are still searching for a trial to take part in, over 1250 trials related to prostate cancer that is resistant to castration and 98 studies involving BI 836845 are currently seeking participants."

Answered by AI

What is the size of the cohort engaging in this research?

"Unfortunately, this research project is no longer enrolling patients. It was initially posted on November 11th 2014 and its information was most recently edited on 15/11/2022. For those searching for alternative studies, there are currently 1252 trials accepting participants diagnosed with prostatic cancer resistant to castration treatments as well as 98 clinical experiments that accept participants being treated with BI 836845."

Answered by AI

Is BI 836845 a safe and efficacious treatment for patients?

"Our assessment of the safety profile for BI 836845 is a 1, as this Phase 1 trial includes limited data regarding both efficacy and safety."

Answered by AI

Could you provide an overview of the experiments which have already been conducted regarding BI 836845?

"BI 836845 was initially studied in 2005 at the Rosemere Cancer Centre located at Royal Preston Hospital. As of today, there have been 89 completed studies with 98 actively recruiting clinical trials; many of these are based out of New york City."

Answered by AI
~12 spots leftby Mar 2025