18 and older, any sex, with Neoplasms or NUT Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase Ia: Number of Patients With DLTs Observed in the First CyclePrimary· First treatment cycle (the first 21 days for Schedules A and B, the first 28 days for Schedule C).
Number of patients with Dose Limiting Toxicities (DLTs) observed in the first treatment cycle of Phase Ia is reported.
The following drug related adverse events (AEs) qualified as DLT:
* any Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non haematological toxicity considered related to trial medication with the following exceptions:
* inadequately treated nausea, vomiting or diarrhoea. For fatigue, if present at baseline, there had to be an increase of ≥2 grades
* electrolytes abnormalities that were corrected within 72 hours with treatment
* any haematologic AE relate
Group
Value
95% CI
Phase Ia - Schedule A: 0.2 mg BI 894999
0
Phase Ia - Schedule A: 0.5 mg BI 894999
0
Phase Ia - Schedule A: 1 mg BI 894999
0
Phase Ia - Schedule A: 1.5 mg BI 894999
0
Phase Ia - Schedule A: 2 mg BI 894999
3
Phase Ia - Schedule A: 5 mg BI 894999
2
Phase Ia - Schedule B: 1.5 mg BI 894999
1
Phase Ia - Schedule B: 2 mg BI 894999
0
Phase Ia - Schedule B: 2.5 mg BI 894999
2
Phase Ia - Schedule C: 5/2.5 mg BI 894999
0
Phase Ia - Schedule C: 6/3 mg BI 894999
2
Phase Ia - Schedule C: 7/3.5 mg BI 894999
4
Phase Ib: Number of Patients With DLTs Observed During the On-treatment PeriodPrimary· Date of the first administration of study treatment until date of the last administration of study treatment + 30 days residual effect period, up to 883 days.
Number of patients with Dose Limiting Toxicities (DLTs) observed during the on-treatment period of Phase Ib is reported.
The following drug related adverse events (AEs) qualified as DLT:
* any Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non haematological toxicity considered related to trial medication with the following exceptions:
* inadequately treated nausea, vomiting or diarrhoea. For fatigue, if present at baseline, there had to be an increase of ≥2 grades
* electrolytes abnormalities that were corrected within 72 hours with treatment
* any haematologic AE rela
Group
Value
95% CI
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (SCLC Patients)
Phase Ib - Schedule C: 6/3 or 7/3.5 mg BI 894999 (NC Patients)
3
Phase Ia: Number of Patients With DLTs Observed During the On-treatment PeriodSecondary· Date of the first administration of study treatment until date of the last administration of study treatment + 30 days residual effect period, up to 463 days.
Number of patients with DLTs observed during the on-treatment period of Phase Ia is reported.
The following drug related adverse events (AEs) qualified as DLT:
* any Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non haematological toxicity considered related to trial medication with the following exceptions:
* inadequately treated nausea, vomiting or diarrhoea. For fatigue, if present at baseline, there had to be an increase of ≥2 grades
* electrolytes abnormalities that were corrected within 72 hours with treatment
* any haematologic AE related to the trial medication
Group
Value
95% CI
Phase Ia - Schedule A: 0.2 mg BI 894999
0
Phase Ia - Schedule A: 0.5 mg BI 894999
0
Phase Ia - Schedule A: 1 mg BI 894999
0
Phase Ia - Schedule A: 1.5 mg BI 894999
2
Phase Ia - Schedule A: 2 mg BI 894999
4
Phase Ia - Schedule A: 5 mg BI 894999
2
Phase Ia - Schedule B: 1.5 mg BI 894999
1
Phase Ia - Schedule B: 2 mg BI 894999
0
Phase Ia - Schedule B: 2.5 mg BI 894999
3
Phase Ia - Schedule C: 5/2.5 mg BI 894999
1
Phase Ia - Schedule C: 6/3 mg BI 894999
3
Phase Ia - Schedule C: 7/3.5 mg BI 894999
4
Phase Ia and Phase Ib: Area Under the Concentration-time Curve of BI 894999 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24)Secondary· 5 minutes (min) before and at 30 min, 1 hour (h), 2h, 3h, 4h, 6h, 8h and 23h55min after administration of first BI 894999 dose on Day 1 of Cycle 1.
Area under the concentration-time curve of BI 894999 in plasma over the time interval from 0 to 24 hours after administration of the first dose (AUC0-24) for Phase Ia and Phase Ib is reported.
Group
Value
95% CI
Phase Ia - Schedule A: 0.2 mg BI 894999
4.36
± 21.1
Phase Ia - Schedule A: 0.5 mg BI 894999
6.43
± 2.78
Phase Ia - Schedule A: 1 mg BI 894999
20.5
± 16.8
Phase Ia - Schedule A: 1.5 mg BI 894999
34.0
± 69.4
Phase Ia - Schedule A: 2 mg BI 894999
64.9
± 71.0
Phase Ia - Schedule B: 1.5 mg BI 894999
27.7
± 81.5
Phase Ia - Schedule B: 2 mg BI 894999
44.8
± 34.8
Phase Ia - Schedule B: 2.5 mg BI 894999
51.5
± 41.7
Phase Ia - Schedule C: 5/2.5 mg BI 894999
123
± 37.6
Phase Ia - Schedule C: 6/3 mg BI 894999
212
± 45.5
Phase Ia - Schedule C: 7/3.5 mg BI 894999
230
± 27.3
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
31.7
± 33.4
Phase Ia and Phase Ib: Maximum Measured Concentration of BI 894999 in Plasma After the First Dose (Cmax)Secondary· 5 minutes (min) before and at 30 min, 1 hour (h), 2h, 3h, 4h, 6h, 8h and 23h55min after administration of first BI 894999 dose on Day 1 of Cycle 1.
Maximum measured concentration of BI 894999 in plasma after the first dose (Cmax) for Phase 1a and Phase 1b is reported.
Group
Value
95% CI
Phase Ia - Schedule A: 0.2 mg BI 894999
0.393
± 35.6
Phase Ia - Schedule A: 0.5 mg BI 894999
0.569
± 46.2
Phase Ia - Schedule A: 1 mg BI 894999
1.75
± 31.6
Phase Ia - Schedule A: 1.5 mg BI 894999
3.79
± 84.0
Phase Ia - Schedule A: 2 mg BI 894999
7.39
± 56.0
Phase Ia - Schedule A: 5 mg BI 894999
16.2
± 68.0
Phase Ia - Schedule B: 1.5 mg BI 894999
3.00
± 155
Phase Ia - Schedule B: 2 mg BI 894999
3.93
± 50.2
Phase Ia - Schedule B: 2.5 mg BI 894999
4.48
± 46.6
Phase Ia - Schedule C: 5/2.5 mg BI 894999
12.0
± 85.1
Phase Ia - Schedule C: 6/3 mg BI 894999
19.4
± 58.4
Phase Ia - Schedule C: 7/3.5 mg BI 894999
21.0
± 48.3
Phase Ia and Phase Ib: Area Under the Concentration-time Curve of BI 894999 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ, ss)Secondary· 5 minutes (min) before and at 30 min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, and at 23h55min (Schedule A) or 24h (Schedule B & C) following administration on day 14 (Schedule A & B) or day 21 (Schedule C).
Area under the concentration-time curve of BI 894999 in plasma at steady state over a uniform dosing interval τ (AUCτ, ss) for Phase Ia and Ib is reported. The dosing interval is 24 hours (h) for all dose groups.
Group
Value
95% CI
Phase Ia - Schedule A: 0.2 mg BI 894999
10.3
± 72.6
Phase Ia - Schedule A: 0.5 mg BI 894999
17.9
± 46.4
Phase Ia - Schedule A: 1 mg BI 894999
54.6
± 40.4
Phase Ia - Schedule A: 1.5 mg BI 894999
76.4
± 26.6
Phase Ia - Schedule A: 2 mg BI 894999
119
± 90.3
Phase Ia - Schedule A: 5 mg BI 894999
NA
± NA
Phase Ia - Schedule B: 1.5 mg BI 894999
62.6
± 49.2
Phase Ia - Schedule B: 2 mg BI 894999
81.1
± 32.1
Phase Ia - Schedule B: 2.5 mg BI 894999
87.0
± 28.3
Phase Ia - Schedule C: 5/2.5 mg BI 894999
144
± 46.4
Phase Ia - Schedule C: 6/3 mg BI 894999
176
± 37.0
Phase Ia - Schedule C: 7/3.5 mg BI 894999
226
± 63.2
Phase Ia and Phase Ib: Maximum Measured Concentration of BI 894999 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax, ss)Secondary· 5 minutes (min) before and at 30 min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, and at 23h55min (Schedule A) or 24h (Schedule B & C) following administration on day 14 (Schedule A & B) or day 21 (Schedule C).
Maximum measured concentration of BI 894999 in plasma at steady state over a uniform dosing interval τ (Cmax, ss) for Phase Ia and Phase Ib is reported. The dosing interval is 24 hours (h) for all dose groups.
Group
Value
95% CI
Phase Ia - Schedule A: 0.2 mg BI 894999
0.697
± 59.8
Phase Ia - Schedule A: 0.5 mg BI 894999
1.26
± 24.9
Phase Ia - Schedule A: 1 mg BI 894999
4.06
± 61.7
Phase Ia - Schedule A: 1.5 mg BI 894999
5.25
± 60.1
Phase Ia - Schedule A: 2 mg BI 894999
11.6
± 54.4
Phase Ia - Schedule A: 5 mg BI 894999
NA
± NA
Phase Ia - Schedule B: 1.5 mg BI 894999
4.75
± 46.9
Phase Ia - Schedule B: 2 mg BI 894999
5.62
± 27.7
Phase Ia - Schedule B: 2.5 mg BI 894999
6.94
± 42.0
Phase Ia - Schedule C: 5/2.5 mg BI 894999
11.4
± 56.1
Phase Ia - Schedule C: 6/3 mg BI 894999
13.1
± 41.8
Phase Ia - Schedule C: 7/3.5 mg BI 894999
17.1
± 63.6
Phase Ia and Phase Ib: Objective Response (OR)Secondary· Up to 15 months for Phase 1a and up to 28 months for Phase Ib.
OR was defined as best overall response (BOR) of complete response (CR) or partial response (PR) with tumour assessment during treatment period for each schedule.
For DLBCL patients, a minor response according to Response Evaluation Criteria In Lymphoma 2017 (RECIL 2017) was not part of an objective response.
BOR was determined from first treatment administration until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent, according to the following criteria depending on the typ
Group
Value
95% CI
Phase Ia - Schedule A: 0.2 mg BI 894999
0
Phase Ia - Schedule A: 0.5 mg BI 894999
1
Phase Ia - Schedule A: 1 mg BI 894999
0
Phase Ia - Schedule A: 1.5 mg BI 894999
1
Phase Ia - Schedule A: 2 mg BI 894999
0
Phase Ia - Schedule A: 5 mg BI 894999
0
Phase Ia - Schedule B: 1.5 mg BI 894999
1
Phase Ia - Schedule B: 2 mg BI 894999
0
Phase Ia - Schedule B: 2.5 mg BI 894999
0
Phase Ia - Schedule C: 5/2.5 mg BI 894999
0
Phase Ia - Schedule C: 6/3 mg BI 894999
0
Phase Ia - Schedule C: 7/3.5 mg BI 894999
0
Phase Ib: Progression-free Survival or (PFS) or Radiological PFS for mCRPC Patients With Non-measurable Disease by RECIST v1.1Secondary· Up to 28 months.
Progression-free survival (PFS) was defined as the time from date of start of BI 894999 to the date of objective disease progression ((PD) defined as 20% increase in the sum of the longest diameter of target lesions) or death, whichever is earlier for SCLC patients, CRC patients, mCRPC patients with measurable disease by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and NC patients, with tumour assessment every 2 cycles according to RECIST v1.1 during treatment period or Radiological PFS with tumour assessment by bone scan every 4 cycles for mCRPC patients with non-measur
Group
Value
95% CI
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (SCLC Patients)
Phase Ib - Schedule C: 6/3 or 7/3.5 mg BI 894999 (NC Patients)
7.8
4.0 – 13.0
Phase Ib: Best Overall ResponseSecondary· Imaging and assessment performed every 2 cycles (solid tumours patients) or 4 cycles (mCRPC patients) for the entire treatment period, up to 28 months.
Best overall response (BOR) was determined from first treatment administration until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent, according to the following criteria depending on the type of cancer:
* solid tumour patients and mCRPC patients with measurable disease: Computerized tomography (CT) and/ or magnetic resonance imaging (MRI) according to RECIST v1.1, every 2 cycles;
* mCRPC patients without measurable disease: bone scan and PSA level according to Prostate Canc
Complete response
Group
Value
95% CI
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (SCLC Patients)
Phase Ib - Schedule C: 6/3 or 7/3.5 mg BI 894999 (NC Patients)
0
Phase Ib: Overall SurvivalSecondary· Up to 28 months.
Overall survival (OS) was defined as the time from first administration of BI 894999 until death from any cause in patients with NUT carcinoma.
For patients with 'event' as an outcome for OS:
\- OS \[days\] = date of outcome - date of first treatment administration + 1.
For patients with 'censored' as an outcome for OS:
\- OS (censored) \[days\] = date of outcome - date of first treatment administration + 1.
The Kaplan-Meier method was used to calculate the estimates.
Phase Ib - Schedule C: 6/3 or 7/3.5 mg BI 894999 (NC Patients)
15.4
7.6 – 32.3
Phase Ib: Prostate Specific Antigen (PSA) Response in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)Secondary· Up to 93 days.
PSA response was defined as a decline in PSA value ≥50% from baseline (which is confirmed by a second value 3 to 4 weeks apart).
Group
Value
95% CI
Phase Ib - Schedule B: 2 or 2.5 mg BI 894999 (mCRPC Patients)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: [All-Cause Mortality]: From first date of dosing until end of study, up to 1309 days for Phase Ia and up to 860 days for Phase Ib. [Serious and Other Adverse Events]: From first date of dosing of study treatment until date of the last dosing of study treatment + 30 days residual effect period, up to 463 days for Phase 1a and up to 883 days for Phase Ib..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase Ia - Schedule A: 0.2 mg BI 894999
Serious: 1/2 (50%)
Deaths: 0/2
Phase Ia - Schedule A: 0.5 mg BI 894999
Serious: 2/2 (100%)
Deaths: 0/2
Phase Ia - Schedule A: 1 mg BI 894999
Serious: 0/3 (0%)
Deaths: 0/3
Phase Ia - Schedule A: 1.5 mg BI 894999
Serious: 3/6 (50%)
Deaths: 1/6
Phase Ia - Schedule A: 2 mg BI 894999
Serious: 2/6 (33%)
Deaths: 1/6
Phase Ia - Schedule A: 5 mg BI 894999
Serious: 1/2 (50%)
Deaths: 0/2
Phase Ia - Schedule B: 1.5 mg BI 894999
Serious: 3/6 (50%)
Deaths: 1/6
Phase Ia - Schedule B: 2 mg BI 894999
Serious: 3/6 (50%)
Deaths: 1/6
Phase Ia - Schedule B: 2.5 mg BI 894999
Serious: 6/13 (46%)
Deaths: 2/13
Phase Ia - Schedule C: 5/2.5 mg BI 894999
Serious: 2/4 (50%)
Deaths: 0/4
Phase Ia - Schedule C: 6/3 mg BI 894999
Serious: 8/15 (53%)
Deaths: 2/15
Phase Ia - Schedule C: 7/3.5 mg BI 894999
Serious: 8/12 (67%)
Deaths: 1/12
Phase Ia - Schedule B: 1.5 mg BI 894999 (DLBCL Patients)
Serious: 3/8 (38%)
Deaths: 0/8
Phase Ia - Schedule B: 2 mg BI 894999 (DLBCL Patients)
Serious: 2/4 (50%)
Deaths: 0/4
Phase Ia - Schedule B: 2.5 mg BI 894999 (DLBCL Patients)
Serious: 2/2 (100%)
Deaths: 0/2
Phase Ia - Schedule C: 4/2 mg BI 894999 (DLBCL Patients
Serious: 1/2 (50%)
Deaths: 1/2
Phase Ia - Schedule C: BI 894999 5/2.5 mg (DLBCL Patients)
This study is open to adults with different types of advanced cancer (solid tumours). The study is also open to patients with diffuse large B-cell lymphoma in whom previous treatment was not successful. In some countries, adolescents who are at least 15 years old and who are diagnosed with NUT carcinoma can also participate. No standard treatment exists for this rare and aggressive form of cancer.
The purpose of this study is to find out the highest dose of BI 894999 that people can tolerate.
BI 894999 is tested for the first time in humans. Participants take tablets once daily. The study also tests whether participants can tolerate BI 894999 better when taken continuously or with breaks in between.
Participants can stay in the study as long as they benefit from the treatment and can tolerate it.
The doctors also regularly check the general health of the participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 15 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02516553.