Covid 19 Research Clinical Trials by Shray Alag

BI 894999

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Correlated Drug Terms (2)

	Name (Synonyms)	Correlation
drug1016	Computerized Talking Touchscreen Wiki	0.58
drug2887	Phone Administration of Questionnaires Wiki	0.58

Correlated MeSH Terms (1)

	Name (Synonyms)	Correlation
D002277	Carcinoma NIH	0.20

Correlated HPO Terms (1)

	Name (Synonyms)	Correlation
HP:0030731	Carcinoma HPO	0.20

Clinical Trials

Navigate: Correlations HPO

There are 3 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

Conditions

Neoplasms
NUT Carcinoma

Interventions

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

NCT02516553

Conditions

Neoplasms
NUT Carcinoma

Interventions

Drug: BI 894999
Drug: BI 894999
Drug: BI 894999

MeSH:Carcinoma

HPO:Carcinoma

Primary Outcomes

Time: average of 12 months

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

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

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

NCT02516553

Conditions

Neoplasms
NUT Carcinoma

Interventions

Drug: BI 894999
Drug: BI 894999
Drug: BI 894999

MeSH:Carcinoma

HPO:Carcinoma

Primary Outcomes

Time: average of 12 months

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

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

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

HPO

Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials

Related HPO nodes (Using clinical trials)

HP:0030731: Carcinoma

Genes 12

RSPO1 POLD1 DKC1 APC CDKN1B NLRP1 MLH1 MSH2 PTEN APC POLE SMARCA4

Protein Mutations 59

SNP 5

rs11568821 rs12979860 rs1799750 rs2075606 rs9679162

Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports MeSH Reports HPO Reports

Report Sections

See All Reports

BI 894999

Correlations computed by analyzing all clinical trials.

Correlated Drug Terms (2)

Correlated MeSH Terms (1)

Correlated HPO Terms (1)

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 Click for details

NCT02516553

Conditions

Interventions

MeSH:Carcinoma

HPO:Carcinoma

Primary Outcomes

Secondary Outcomes

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 Click for details

NCT02516553

Conditions

Interventions

MeSH:Carcinoma

HPO:Carcinoma

Primary Outcomes

Secondary Outcomes

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 Click for details

NCT02516553

Conditions

Interventions

MeSH:Carcinoma

HPO:Carcinoma

Primary Outcomes

Secondary Outcomes

Related HPO nodes (Using clinical trials)

Genes 12

Protein Mutations 59

SNP 5

HPO

Related HPO nodes (Using clinical trials)

Genes 12

Protein Mutations 59

SNP 5

Reports

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

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

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