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BI 894999Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)

Name (Synonyms) Correlation
drug652 Convalescent Plasma Transfusion Wiki 0.41
drug1219 Interferon Beta-1A Wiki 0.29
drug698 DAS181 Wiki 0.24
drug1270 Ivermectin Wiki 0.14
drug1086 Hydroxychloroquine Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D002277 Carcinoma NIH 0.26

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0030731 Carcinoma HPO 0.26

There are 3 clinical trials

Clinical Trials

1 An Open Label, Phase Ia/Ib Dose Finding Study With BI 894999 Orally Administered Once a Day in Patients With Advanced Malignancies, With Repeated Administration in Patients With Clinical Benefit

The aim of the phase Ia (dose escalation) part of this trial is to assess-> determine the Maximum Tolerated Dose (MTD) using a continuous dosing schedule A, using an intermittent Schedule B (2 weeks on, one week off in 3-week cycles) and the MTD using an intermittent Schedule C (one week on followed by one week off treatment, repeated every two weeks in 4-week cycles) in patients with solid tumours. In the phase Ib expansion part, the aim is to further evaluate the safety profile of BI 894999 at the dose recommended by the data monitoring committee (DMC). Once the MTD has been determined for both schedules A and B in patients with solid tumours, the MTD will be determined as well in patients with diffuse large B-cell lymphoma (DLBCL), using the DMC recommended schedule for solid tumours

NCT02516553 Neoplasms NUT Carcinoma Drug: BI 894999 Drug: BI 894999 Drug: BI 894999
MeSH:Carcinoma
HPO:Carcinoma

Primary Outcomes

Measure: In phase Ib: Number of patients experiencing DLTs from start of treatment until end of treatment (in all cycles) as assessed approximately every 3 weeks after Cycle 2 (at the end of each new cycle) in order to determine the recommended phase II dose

Time: average of 12 months

Measure: In phase Ia: Number of patients with DLT observed in the first cycle (first 21 days) for Schedules A and B, first 28 days for Schedule C), to meet objective of assessing MTD for each schedule in solid tumour patients & in schedule B in the DLBCL cohort

Time: Up to 4 weeks

Secondary Outcomes

Measure: efficacy endpoint in phases Ia and Ib: Objective response (OR), defined as CR or PR with tumour assessment during treatment period for each schedule

Time: every 6 weeks, average of 4 months

Measure: efficacy endpoint in phase Ib: Progression-free Survival (PFS) or radiological PFS

Time: average of 5 months

Measure: efficacy endpoint in phase Ib: Best overall response with an evaluation of approximately every 2 cycles (6 weeks if no delays) during the entire treatment period

Time: every 6 weeks, average of 4 months

Measure: In both phases: Cmax,ss after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: In both phases: AUC0-24 after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: In both phases: AUC tau, ss after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: Phase Ia: Number of patients experiencing DLTs from start of treatment until end of treatment (in all cycles) for each of the schedules (A, B and C) in patients with solid tumours and in schedule B in the DLBCL cohort

Time: average of 12 months

Measure: In both phases: Cmax after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: efficacy endpoint in phase Ib: Prostate Specific Antigen (PSA) response (decline in PSA value ≥50% from baseline) in patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

Time: average of 12 months

Measure: Overall survival in patients with NUT Carcinoma (NC)

Time: Up to 29 months

2 An Open Label, Phase Ia/Ib Dose Finding Study With BI 894999 Orally Administered Once a Day in Patients With Advanced Malignancies, With Repeated Administration in Patients With Clinical Benefit

The aim of the phase Ia (dose escalation) part of this trial is to assess-> determine the Maximum Tolerated Dose (MTD) using a continuous dosing schedule A, using an intermittent Schedule B (2 weeks on, one week off in 3-week cycles) and the MTD using an intermittent Schedule C (one week on followed by one week off treatment, repeated every two weeks in 4-week cycles) in patients with solid tumours. In the phase Ib expansion part, the aim is to further evaluate the safety profile of BI 894999 at the dose recommended by the data monitoring committee (DMC). Once the MTD has been determined for both schedules A and B in patients with solid tumours, the MTD will be determined as well in patients with diffuse large B-cell lymphoma (DLBCL), using the DMC recommended schedule for solid tumours

NCT02516553 Neoplasms NUT Carcinoma Drug: BI 894999 Drug: BI 894999 Drug: BI 894999
MeSH:Carcinoma
HPO:Carcinoma

Primary Outcomes

Measure: In phase Ib: Number of patients experiencing DLTs from start of treatment until end of treatment (in all cycles) as assessed approximately every 3 weeks after Cycle 2 (at the end of each new cycle) in order to determine the recommended phase II dose

Time: average of 12 months

Measure: In phase Ia: Number of patients with DLT observed in the first cycle (first 21 days) for Schedules A and B, first 28 days for Schedule C), to meet objective of assessing MTD for each schedule in solid tumour patients & in schedule B in the DLBCL cohort

Time: Up to 4 weeks

Secondary Outcomes

Measure: efficacy endpoint in phases Ia and Ib: Objective response (OR), defined as CR or PR with tumour assessment during treatment period for each schedule

Time: every 6 weeks, average of 4 months

Measure: efficacy endpoint in phase Ib: Progression-free Survival (PFS) or radiological PFS

Time: average of 5 months

Measure: efficacy endpoint in phase Ib: Best overall response with an evaluation of approximately every 2 cycles (6 weeks if no delays) during the entire treatment period

Time: every 6 weeks, average of 4 months

Measure: In both phases: Cmax,ss after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: In both phases: AUC0-24 after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: In both phases: AUC tau, ss after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: Phase Ia: Number of patients experiencing DLTs from start of treatment until end of treatment (in all cycles) for each of the schedules (A, B and C) in patients with solid tumours and in schedule B in the DLBCL cohort

Time: average of 12 months

Measure: In both phases: Cmax after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: efficacy endpoint in phase Ib: Prostate Specific Antigen (PSA) response (decline in PSA value ≥50% from baseline) in patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

Time: average of 12 months

Measure: Overall survival in patients with NUT Carcinoma (NC)

Time: Up to 29 months

3 An Open Label, Phase Ia/Ib Dose Finding Study With BI 894999 Orally Administered Once a Day in Patients With Advanced Malignancies, With Repeated Administration in Patients With Clinical Benefit

The aim of the phase Ia (dose escalation) part of this trial is to assess-> determine the Maximum Tolerated Dose (MTD) using a continuous dosing schedule A, using an intermittent Schedule B (2 weeks on, one week off in 3-week cycles) and the MTD using an intermittent Schedule C (one week on followed by one week off treatment, repeated every two weeks in 4-week cycles) in patients with solid tumours. In the phase Ib expansion part, the aim is to further evaluate the safety profile of BI 894999 at the dose recommended by the data monitoring committee (DMC). Once the MTD has been determined for both schedules A and B in patients with solid tumours, the MTD will be determined as well in patients with diffuse large B-cell lymphoma (DLBCL), using the DMC recommended schedule for solid tumours

NCT02516553 Neoplasms NUT Carcinoma Drug: BI 894999 Drug: BI 894999 Drug: BI 894999
MeSH:Carcinoma
HPO:Carcinoma

Primary Outcomes

Measure: In phase Ib: Number of patients experiencing DLTs from start of treatment until end of treatment (in all cycles) as assessed approximately every 3 weeks after Cycle 2 (at the end of each new cycle) in order to determine the recommended phase II dose

Time: average of 12 months

Measure: In phase Ia: Number of patients with DLT observed in the first cycle (first 21 days) for Schedules A and B, first 28 days for Schedule C), to meet objective of assessing MTD for each schedule in solid tumour patients & in schedule B in the DLBCL cohort

Time: Up to 4 weeks

Secondary Outcomes

Measure: efficacy endpoint in phases Ia and Ib: Objective response (OR), defined as CR or PR with tumour assessment during treatment period for each schedule

Time: every 6 weeks, average of 4 months

Measure: efficacy endpoint in phase Ib: Progression-free Survival (PFS) or radiological PFS

Time: average of 5 months

Measure: efficacy endpoint in phase Ib: Best overall response with an evaluation of approximately every 2 cycles (6 weeks if no delays) during the entire treatment period

Time: every 6 weeks, average of 4 months

Measure: In both phases: Cmax,ss after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: In both phases: AUC0-24 after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: In both phases: AUC tau, ss after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: Phase Ia: Number of patients experiencing DLTs from start of treatment until end of treatment (in all cycles) for each of the schedules (A, B and C) in patients with solid tumours and in schedule B in the DLBCL cohort

Time: average of 12 months

Measure: In both phases: Cmax after single dose and at steady state, as measured during the first cycle (3 weeks) for Schedules A and B, the first 4 weeks for Schedule C)

Time: up to 4 weeks

Measure: efficacy endpoint in phase Ib: Prostate Specific Antigen (PSA) response (decline in PSA value ≥50% from baseline) in patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

Time: average of 12 months

Measure: Overall survival in patients with NUT Carcinoma (NC)

Time: Up to 29 months

Related HPO nodes (Using clinical trials)

HP:0030731: Carcinoma
Genes 16
BCL10 MLH1 MSH2 PTEN CDKN1B RSPO1 SMARCA4 NLRP1 APC POLE APC POLD1 FGFR3 STK11 DKC1 KIT
Protein Mutations 57
C3435T C420R C938A E10A E542K E545A E545D E545G E545K G1049R G12C G20210A G719A H1047L H1047R H1047Y I105V I10A K751Q L8585R L858R L861Q M1043I N345K N375S P13K P286R Q12W Q546E Q546K Q546L Q546R R399Q R776G R831C R88Q S100P S1400A S1400C S1400D S1400E S1400F S1400G S1400I S1400K S1900A S1900C S1900D S768I T790M V411L V600E V600K V600R V617F V762A V843I
SNP 5
rs11568821 rs12979860 rs1799750 rs2075606 rs9679162