A Phase 1 interventional study of BI 905711 and FOLFIRI in Gastrointestinal Cancer, Metastatic, sponsored by Boehringer Ingelheim. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
This study is open to adults with advanced colorectal cancer or with advanced pancreatic cancer. The study has 2 parts. In the first part, participants with colorectal cancer get a medicine called BI 905711 combined with chemotherapy and bevacizumab. The purpose of the first part is to find the highest BI 905711 dose participants can tolerate. In the second part, participants with colorectal cancer or pancreatic cancer get BI 905711 combined with chemotherapy. Some participants also get bevacizumab. The second part tests whether BI 905711 makes tumours shrink. Participants get BI 905711, chemotherapy and bevacizumab about every 2 weeks as an infusion into a vein. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors regularly check the health of the participants and note any health problems that could have been caused by the study treatment. The doctors also monitor the size of the tumour.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
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Adequate hepatic, pancreatic, renal and bone marrow functions as defined by all of the below:
Exclusion criteria:
Previous systemic anti-cancer therapy within the specified timeframe from the last dose intake to the first dose of trial treatment as follows:
Known pathological condition of GI tract, liver and pancreas, excluding the disease under study, that may interfere with assessment of drug safety or may increase the risk of toxicity:
Any of the following laboratory evidence of hepatitis virus infection. Test results obtained in routine diagnostics are acceptable if done within 14 days before the informed consent date:
Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 milligrams (mg) / kilograms (kg) of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/squaremeters (m2) over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Drug: BI 905711 · Drug: FOLFIRI · Drug: Bevacizumab
Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Drug: BI 905711 · Drug: FOLFIRI · Drug: Bevacizumab
Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Drug: FOLFIRI · Drug: Bevacizumab
BI 905711
FOLFIRI
Bevacizumab
Determination of the Maximum Tolerated Dose (MTD) of BI 905711
Maximum tolerated dose (MTD) was defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. The MTD was to be considered reached if one of the following criteria was fulfilled: the posterior probability of the true DLT rate in the target interval (0.16, 0.33) of the MTD was above 0.5, or at least 12 patients had been treated in Phase Ia, of which at least 6 at the MTD.
Time frame: From cycle 1 Day 1 until the day before cycle 3 Day 1 (2 14-day treatment cycles), or end of the residual effect period (REP) (30 days + 5 days) in case of discontinuation before start of cycle 3, up to 35 days.
Number of Patients With Dose Limiting Toxicity (DLT) During MTD Evaluation
Number of patients with dose limiting toxicity (DLT) during MTD evaluation is presented.
Time frame: From cycle 1 Day 1 until the day before cycle 3 Day 1 (2 14-day treatment cycles), or end of the REP (30 days + 5 days) in case of discontinuation before start of cycle 3, up to 35 days.
Confirmed Objective Response (OR)
Confirmed objective response (OR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI in patients with measurable disease, defined as the best overall response of complete response (CR) or partial response (PR), from the first administration of trial medication until the earliest of progressive disease (PD), death or last evaluable tumor assessment before start of subsequent anti-cancer therapy.
Time frame: From the first administration of trial medication until the earliest of progressive disease (PD), death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, up to 54 weeks.
Number of PDAC Patients With DLTs During the MTD Evaluation Period Assessed in the First 6 Patients
In safety run-in part of Pancreatic Ductal Adenocarcinoma (PDAC) cohort. Number of PDAC patients with DLTs during the MTD evaluation period assessed in the first 6 patients is presented.
Time frame: From cycle 1 Day 1 until the day before cycle 3 Day 1 (2 14-day treatment cycles), or end of the REP (30 days + 5 days) in case of discontinuation before start of cycle 3, up to 35 days.
Maximum Measured Plasma Concentration of BI 905711 During the First Cycle (Cmax)
Maximum measured plasma concentration of BI 905711 during the first cycle (Cmax) in phase Ia is presented.
Time frame: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1.
Maximum Measured Plasma Concentration of BI 905711 After Multiple Cycles (Cmax)
Maximum measured plasma concentration of BI 905711 after multiple cycles (Cmax) in phase Ia is presented.
Time frame: Cycle 3: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.
Area Under the Concentration-time Curve in Plasma of BI 905711 During the First Cycle (AUC0-336)
Area under the concentration-time curve in plasma of BI 905711 during the first cycle (AUC0-336) in phase Ia is presented.
Time frame: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1.
Area Under the Concentration Time-curve in Plasma of BI 905711 After Multiple Cycles (AUC0-336)
Area under the concentration time-curve in plasma of BI 905711 after multiple cycles (AUC0-336) in phase Ia is presented.
Time frame: Cycle 3: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.
Progression Free Survival (PFS)
Progression-Free Survival (PFS) defined from date of start of treatment to the date of disease progression or death, whichever is earlier as assessed by the investigator according to RECIST 1.1 is presented.
Time frame: From date of start of treatment to the date of disease progression or death, whichever is earlier as assessed by the investigator according to RECIST 1.1., up to 54 weeks.
Maximum Percentage Change From Baseline in the Sum of Longest Target Lesion Diameters
Radiological (CT Scan) tumor shrinkage, 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 according to RECIST 1.1. is presented. Negative values indicate a reduction in the sum of target lesion diameters and positive values indicate an increase. Median change from baseline was calculated for each patient and then summarized over all patients.
Time frame: At baseline and every 8 weeks (± 7 days) until progression or start of further treatment for disease, up to 54 weeks.
Duration of Objective Response (OR)
The duration of OR is measured from the time measurement criteria are first met for complete response (CR)/ partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded on study) according to RECIST 1.1. .
Time frame: From the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or PD is objectively documented, up to 54 weeks.
Disease Control
Disease control, defined as complete response (CR), partial response (PR), or stable disease (SD) lasting at least 16 weeks according to RECIST 1.1 from the start of treatment until the earliest of PD, death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy.
Time frame: From the start of treatment until the earliest of PD, death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy, up to 54 weeks.
Maximum Measured Plasma Concentration of BI 905711 During the First Cycle (Cmax) in Phase Ib
Maximum measured plasma concentration of BI 905711 during the first cycle (Cmax) in phase Ib is presented.
Time frame: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1.
Maximum Measured Plasma Concentration of BI 905711 After Multiple Cycles (Cmax) in Phase Ib
Maximum measured plasma concentration of BI 905711 after multiple cycles (Cmax) in phase Ib is presented.
Time frame: Cycle 3: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.
Area Under the Concentration-time Curve of BI 9057 During the First Treatment Cycle (AUC0-t2) in Phase Ib
Area under the concentration-time curve of BI 9057 during the first treatment cycle (AUC0-t2) in phase Ib is presented.
Time frame: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1.
Area Under the Concentration-time Curve of BI 9057 After Multiple Cycles (AUC0-t2) in Phase Ib
Area under the concentration-time curve of BI 9057 after multiple cycles (AUC0-t2) in phase Ib is presented.
Time frame: Cycle 3: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.
The main objective of this phase Ia/Ib, open label, multicentre, dose escalation followed by expansion cohorts study was to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE), and to explore the pharmacokinetics, pharmacodynamics, safety and efficacy of BI 905711 in combination with FOLFIRI regimen plus bevacizumab in colorectal adenocarcinoma (CRC) patients.
| Milestone | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab |
|---|---|---|---|
| Started | 9 | 3 | 1 |
| Completed | 0 | 0 | 1 |
| Not completed | 9 | 3 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Clinical disease progression | 3 | 1 | 0 |
| Withdrew: Objective disease progression | 4 | 1 | 0 |
Maximum tolerated dose (MTD) was defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. The MTD was to be considered reached if one of the following criteria was fulfilled: the posterior probability of the true DLT rate in the target interval (0.16, 0.33) of the MTD was above 0.5, or at least 12 patients had been treated in Phase Ia, of which at least 6 at the MTD.
| milligram / kilogram (mg/kg) | BI 905711 + FOLFIRI + Bevacizumab |
|---|---|
| Determination of the Maximum Tolerated Dose (MTD) of BI 905711 | NA |
Number of patients with dose limiting toxicity (DLT) during MTD evaluation is presented.
| Participants | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab |
|---|---|---|
| Number of Patients With Dose Limiting Toxicity (DLT) During MTD Evaluation | 0 | 2 |
Confirmed objective response (OR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI in patients with measurable disease, defined as the best overall response of complete response (CR) or partial response (PR), from the first administration of trial medication until the earliest of progressive disease (PD), death or last evaluable tumor assessment before start of subsequent anti-cancer therapy.
| Participants | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab |
|---|---|---|---|
| Confirmed Objective Response (OR) | 0 | 0 | 0 |
In safety run-in part of Pancreatic Ductal Adenocarcinoma (PDAC) cohort. Number of PDAC patients with DLTs during the MTD evaluation period assessed in the first 6 patients is presented.
No measurements were reported for this outcome.
Maximum measured plasma concentration of BI 905711 during the first cycle (Cmax) in phase Ia is presented.
| nanograms / milliliter (ng/ml) | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab |
|---|---|---|
| Maximum Measured Plasma Concentration of BI 905711 During the First Cycle (Cmax) | 6100 ± 36.6 | 11500 ± 23.9 |
Maximum measured plasma concentration of BI 905711 after multiple cycles (Cmax) in phase Ia is presented.
| nanograms/milliliter (ng/ml) | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab |
|---|---|---|
| Maximum Measured Plasma Concentration of BI 905711 After Multiple Cycles (Cmax) | 6660 ± 25.4 | 9280 ± 23.8 |
Area under the concentration-time curve in plasma of BI 905711 during the first cycle (AUC0-336) in phase Ia is presented.
| hours * nanograms/milliliter (h*ng/ml) | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab |
|---|---|---|
| Area Under the Concentration-time Curve in Plasma of BI 905711 During the First Cycle (AUC0-336) | 372000 ± 53.4 | 702000 ± 49.4 |
Area under the concentration time-curve in plasma of BI 905711 after multiple cycles (AUC0-336) in phase Ia is presented.
| hours * nanograms/milliliter (h*ng/ml) | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab |
|---|---|---|
| Area Under the Concentration Time-curve in Plasma of BI 905711 After Multiple Cycles (AUC0-336) | 352000 ± 73.3 | 565000 ± 29.0 |
Progression-Free Survival (PFS) defined from date of start of treatment to the date of disease progression or death, whichever is earlier as assessed by the investigator according to RECIST 1.1 is presented.
| weeks | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab |
|---|---|---|---|
| Progression Free Survival (PFS) | 31.00 (8.43 to 39.29) | 29.57 (11.71 to 33.43) | NA (NA to NA) |
Radiological (CT Scan) tumor shrinkage, 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 according to RECIST 1.1. is presented. Negative values indicate a reduction in the sum of target lesion diameters and positive values indicate an increase. Median change from baseline was calculated for each patient and then summarized over all patients.
| Percentage change in tumor diameter | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab |
|---|---|---|---|
| Maximum Percentage Change From Baseline in the Sum of Longest Target Lesion Diameters | -13.9 (-28.3 to 18.6) | 4.5 (-21.7 to 6.3) | — |
The duration of OR is measured from the time measurement criteria are first met for complete response (CR)/ partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded on study) according to RECIST 1.1. .
No measurements were reported for this outcome.
Disease control, defined as complete response (CR), partial response (PR), or stable disease (SD) lasting at least 16 weeks according to RECIST 1.1 from the start of treatment until the earliest of PD, death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy.
| days | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab |
|---|---|---|---|
| Disease Control | 248.0 (120 to 325) | 220.5 (207 to 234) | — |
Maximum measured plasma concentration of BI 905711 during the first cycle (Cmax) in phase Ib is presented.
No measurements were reported for this outcome.
Maximum measured plasma concentration of BI 905711 after multiple cycles (Cmax) in phase Ib is presented.
No measurements were reported for this outcome.
Area under the concentration-time curve of BI 9057 during the first treatment cycle (AUC0-t2) in phase Ib is presented.
No measurements were reported for this outcome.
Area under the concentration-time curve of BI 9057 after multiple cycles (AUC0-t2) in phase Ib is presented.
No measurements were reported for this outcome.
Collected over Up to 54 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 3/9 (33.3%) | 4/9 (44.4%) | 9/9 (100%) |
| 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 2/3 (66.7%) | 2/3 (66.7%) | 3/3 (100%) |
| FOLFIRI + Bevacizumab | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/9 | 1/3 | 0/1 |
| EnterocolitisGastrointestinal disorders | 0/9 | 1/3 | 0/1 |
| Biliary obstructionHepatobiliary disorders | 0/9 | 1/3 | 0/1 |
| Drug-induced liver injuryHepatobiliary disorders | 0/9 | 1/3 | 0/1 |
| LeukopeniaBlood and lymphatic system disorders | 1/9 | 0/3 | 0/1 |
| NeutropeniaBlood and lymphatic system disorders | 1/9 | 0/3 | 0/1 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/9 | 0/3 | 0/1 |
| Abdominal pain upperGastrointestinal disorders | 1/9 | 0/3 | 0/1 |
| OesophagitisGastrointestinal disorders | 1/9 | 0/3 | 0/1 |
| PyrexiaGeneral disorders | 1/9 | 0/3 | 0/1 |
| Event | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 6/9 | 2/3 | 1/1 |
| NauseaGastrointestinal disorders | 5/9 | 3/3 | 0/1 |
| FatigueGeneral disorders | 2/9 | 1/3 | 1/1 |
| Bilirubin conjugated increasedInvestigations | 1/9 | 0/3 | 1/1 |
| Blood bilirubin increasedInvestigations | 1/9 | 1/3 | 1/1 |
| Blood bilirubin unconjugated increasedInvestigations | 1/9 | 0/3 | 1/1 |
| Neutrophil count decreasedInvestigations | 6/9 | 1/3 | 1/1 |
| White blood cell count decreasedInvestigations | 6/9 | 0/3 | 1/1 |
| Decreased appetiteMetabolism and nutrition disorders | 8/9 | 3/3 | 0/1 |
| Alanine aminotransferase increasedInvestigations | 4/9 | 1/3 | 0/1 |
Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS was used for both safety and efficacy analyses.
| Age, Continuous(Years) | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab | Total |
|---|---|---|---|---|
| Mean | 54.4 ± 10.7 | 60.3 ± 11.2 | NA | 54.6 ± 11.2 |
| Sex: Female, Male(Participants) | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab | Total |
|---|---|---|---|---|
| Female | 5 | 1 | NA | NA |
| Male | 4 | 2 | NA | NA |
| Ethnicity (NIH/OMB)(Participants) | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | NA | NA |
| Not Hispanic or Latino | 9 | 3 | NA | NA |
| Unknown or Not Reported | 0 | 0 | NA | NA |
| Race (NIH/OMB)(Participants) | 0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab | 1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab | FOLFIRI + Bevacizumab | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | NA | NA |
| Asian | 5 | 1 | NA | NA |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | NA | NA |
| Black or African American | 0 | 0 | NA | NA |
| White | 4 | 0 | NA | NA |
| More than one race | 0 | 0 | NA | NA |
| Unknown or Not Reported | 0 | 0 | NA | NA |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
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