Trial · NCT01976741
Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib)
NCT01976741, Phase 1, Completed, Bayer; results first posted 2020-04-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib). Trials, record NCT01976741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01976741
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib)
- NCT number
- NCT01976741
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 168 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Neoplasms
- Interventions
- Rogaratinib (BAY1163877) oral solution, Rogaratinib (BAY1163877) oral tablet, Rogaratinib (BAY1163877) 800 mg BID
- First posted
- 2013-11-06
- Last updated
- 2021-05-06
- Other registries' IDs
- eudract:2013-002155-15
- Results first posted
- 2020-04-28
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD), Defined as Maximum Dose at Which the Incidence of Dose Limiting Toxicities (DLTs) During Cycle 1 is Below 20% | Up to 21 days | The MTD was defined as maximum dose at which the incidence of Dose Limiting Toxicities (DLTs) during Cycle 1 is below 20%. DLT was defined as any of the pre-defined adverse events occurring during Cycle 1 of a dose level and regarded by the investigators and/or sponsor to be related to the investigational drug. BID=twice daily. |
| Primary | Number of DLTs During Cycle 1 | Up to 21 days | DLT was defined as any of the pre-defined adverse events occurring during Cycle 1 of a dose level and regarded by the investigators and/or sponsor to be related to the investigational drug. |
| Primary | Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1) | Maximum drug concentration in plasma (Cmax) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
| Primary | Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2) | Maximum drug concentration in plasma (Cmax) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
| Primary | AUC(0-12) (Area Under the Plasma Concentration vs Time Curve From Time Zero to 12 Hours) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1) | Area under the plasma concentration vs time curve from time zero to 12 hours (AUC(0-12)) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
| Primary | AUC(0-12) (Area Under the Plasma Concentration vs Time Curve From Time Zero to 12 Hours) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2) | Area under the plasma concentration vs time curve from time zero to 12 hours (AUC(0-12)) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
| Primary | AUC(0-tlast) (Area Under the Plasma Concentration vs Time Curve From Time Zero to the Last Data Point > LLOQ [Lower Limit of Quantification]) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1) | Area under the plasma concentration vs time curve from time zero to the last data point \> LLOQ \[lower limit of quantification\] (AUC(0-tlast)) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
| Primary | AUC(0-tlast) (Area Under the Plasma Concentration vs Time Curve From Time Zero to the Last Data Point > LLOQ [Lower Limit of Quantification]) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2) | Area under the plasma concentration vs time curve from time zero to the last data point \> LLOQ \[lower limit of quantification\] (AUC(0-tlast)) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
| Primary | AUC (Area Under the Plasma Concentration vs Time Curve From Zero to Infinity) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1) | Area under the plasma concentration vs time curve from zero to infinity (AUC) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
| Primary | AUC (Area Under the Plasma Concentration vs Time Curve From Zero to Infinity) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2) | Area under the plasma concentration vs time curve from zero to infinity (AUC) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD), Defined as Maximum Dose at Which the Incidence of Dose Limiting Toxicities (DLTs) During Cycle 1 is Below 20% | Up to 21 days | MTD evaluation set: All participants of the total dose-escalation group who completed Cycle 1 or discontinued during Cycle 1 due to an adverse event or DLT. | mg BID | NUMBER |
| PRIMARY | Number of DLTs During Cycle 1 | Up to 21 days | MTD evaluation set: All participants of the total dose-escalation group who completed Cycle 1 or discontinued during Cycle 1 due to an adverse event or DLT. | DLTs | NUMBER |
| PRIMARY | Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1) | All participants with valid pharmacokinetic (PK) data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect. | µg/L | GEOMETRIC_MEAN |
| PRIMARY | Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2) | All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants who received 800 mg BID in either escalation or expansion phase were combined as pre-specified in the Statistical Analysis Plan. | µg/L | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-12) (Area Under the Plasma Concentration vs Time Curve From Time Zero to 12 Hours) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1) | All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect. | µg*h/L | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-12) (Area Under the Plasma Concentration vs Time Curve From Time Zero to 12 Hours) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2) | All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants who received 800 mg BID in either escalation or expansion phase were combined as pre-specified in the Statistical Analysis Plan. | µg*h/L | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-tlast) (Area Under the Plasma Concentration vs Time Curve From Time Zero to the Last Data Point > LLOQ [Lower Limit of Quantification]) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1) | All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect. | µg*h/L | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-tlast) (Area Under the Plasma Concentration vs Time Curve From Time Zero to the Last Data Point > LLOQ [Lower Limit of Quantification]) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2) | All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants who received 800 mg BID in either escalation or expansion phase were combined as pre-specified in the Statistical Analysis Plan. | µg*h/L | GEOMETRIC_MEAN |
| PRIMARY | AUC (Area Under the Plasma Concentration vs Time Curve From Zero to Infinity) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1) | All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect. | µg*h/L | GEOMETRIC_MEAN |
| PRIMARY | AUC (Area Under the Plasma Concentration vs Time Curve From Zero to Infinity) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2) | All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants who received 800 mg BID in either escalation or expansion phase were combined as pre-specified in the Statistical Analysis Plan. | µg*h/L | GEOMETRIC_MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group359
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD), Defined as Maximum Dose at Which the Incidence of Dose Limiting Toxicities (DLTs) During Cycle 1 is Below 20% | Rogaratinib Total Dose Escalation | 800 | mg BID | ||
| Number of DLTs During Cycle 1 | Rogaratinib Total Dose Escalation | 0 | DLTs | ||
| Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | Rogaratinib 100 mg BID | 2760 | Geometric Coefficient of Variation 56.5 | µg/L | |
| Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 | Rogaratinib Expansion Food Effect | 11300 | Geometric Coefficient of Variation 33.8 | µg/L | |
| Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | Rogaratinib 50 mg BID | 3640 | Geometric Coefficient of Variation 16.8 | µg/L | |
| Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | Rogaratinib 100 mg BID | 4360 | Geometric Coefficient of Variation 36.4 | µg/L | |
| Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | Rogaratinib 200 mg BID | 5630 | Geometric Coefficient of Variation 46.2 | µg/L | |
| Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | Rogaratinib 400 mg BID | 9480 | Geometric Coefficient of Variation 16.1 | µg/L | |
| Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | Rogaratinib 600 mg BID | 9060 | Geometric Coefficient of Variation 32.3 | µg/L | |
| Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1 | Rogaratinib 800 mg BID | 10200 | Geometric Coefficient of Variation 17.3 | µg/L |
1 to 10 of 359Source ClinicalTrials.gov
See all 359 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rogaratinib 50 mg BID | 4 | |
| Overall Study | STARTED | Rogaratinib 100 mg BID | 4 | |
| Overall Study | STARTED | Rogaratinib 200 mg BID | 4 | |
| Overall Study | STARTED | Rogaratinib 400 mg BID | 3 | |
| Overall Study | STARTED | Rogaratinib 600 mg BID | 4 | |
| Overall Study | STARTED | Rogaratinib 800 mg BID | 4 | |
| Overall Study | STARTED | Rogaratinib Dose Expansion (All Comers) | 23 | |
| Overall Study | STARTED | Rogaratinib Dose Expansion (BC) | 74 | |
| Overall Study | STARTED | Rogaratinib Dose Expansion (SCCHN) | 8 | |
| Overall Study | STARTED | Rogaratinib Dose Expansion (sqNSCLC) | 40 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,110
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Rogaratinib Total Dose Escalation | 2 | 23 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Rogaratinib Dose Expansion (All Comers) | 4 | 23 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Rogaratinib Dose Expansion (BC) | 17 | 74 | 29 |
| other | Anaemia | Blood and lymphatic system disorders | Rogaratinib Dose Expansion (SCCHN) | 3 | 8 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Rogaratinib Dose Expansion (sqNSCLC) | 12 | 40 | 19 |
| other | Lymphopenia | Blood and lymphatic system disorders | Rogaratinib Total Dose Escalation | 0 | 23 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Rogaratinib Dose Expansion (All Comers) | 0 | 23 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Rogaratinib Dose Expansion (BC) | 0 | 74 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Rogaratinib Dose Expansion (SCCHN) | 0 | 8 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Rogaratinib Dose Expansion (sqNSCLC) | 2 | 40 | 4 |
1 to 10 of 1,110Source ClinicalTrials.gov
See all 1,110 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rogaratinib Total Dose Escalation | 3 | 23 |
| Total, all-cause mortality | Rogaratinib Dose Expansion (All Comers) | 6 | 23 |
| Total, all-cause mortality | Rogaratinib Dose Expansion (BC) | 17 | 74 |
| Total, all-cause mortality | Rogaratinib Dose Expansion (SCCHN) | 2 | 8 |
| Total, all-cause mortality | Rogaratinib Dose Expansion (sqNSCLC) | 12 | 40 |
| Total, other adverse events | Rogaratinib Total Dose Escalation | 22 | 23 |
| Total, other adverse events | Rogaratinib Dose Expansion (All Comers) | 23 | 23 |
| Total, other adverse events | Rogaratinib Dose Expansion (BC) | 73 | 74 |
| Total, other adverse events | Rogaratinib Dose Expansion (SCCHN) | 8 | 8 |
| Total, other adverse events | Rogaratinib Dose Expansion (sqNSCLC) | 40 | 40 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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