TriangleNCT02393248 · STUDY IN CONTEXT
Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
E0 was defined as the Baseline serum concentration of phosphate.
EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.
Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib.
Serum phosphate concentration was assessed throughout Parts 1 and 2.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- trial label
- Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 20
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- source section id
- NCT02393248-om-0000
- source outcome index
- 0
- endpoint
- Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- endpoint definition
- Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
- time origin
- up to 763 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Population: all enrolled participants who received at least 1 dose of study drug
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0001
- source section id
- NCT02393248-om-0001
- source outcome index
- 1
- endpoint
- Part 3: Number of Participants With Any TEAE
- endpoint definition
- Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.
- time origin
- up to 869 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Population
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0002
- source section id
- NCT02393248-om-0002
- source outcome index
- 2
- endpoint
- E0 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
- endpoint definition
- E0 was defined as the Baseline serum concentration of phosphate.
- time origin
- predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Pharmacokinetic/Pharmacodynamic (PK/PD) Population: all enrolled participants who had PK/PD data. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0003
- source section id
- NCT02393248-om-0003
- source outcome index
- 3
- endpoint
- EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
- endpoint definition
- EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.
- time origin
- predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PK/PD Population. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0004
- source section id
- NCT02393248-om-0004
- source outcome index
- 4
- endpoint
- Emax Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
- endpoint definition
- Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib.
- time origin
- predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PK/PD Population. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0005
- source section id
- NCT02393248-om-0005
- source outcome index
- 5
- endpoint
- Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2
- endpoint definition
- Serum phosphate concentration was assessed throughout Parts 1 and 2.
- time origin
- predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PK/PD Population. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part 1: Intermittent Pemigatinib 1/2/4 mg QD
- regimen
- Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part 1: Intermittent Pemigatinib 6 mg QD
- regimen
- Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Parts 1 and 2: Intermittent Pemigatinib 9 mg QD
- regimen
- Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Parts 1 and 2: Intermittent Pemigatinib 13.5 mg QD
- regimen
- Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Part 1: Intermittent Pemigatinib 20 mg QD
- regimen
- Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Parts 1 and 2: Continuous Pemigatinib 9 mg QD
- regimen
- Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Parts 1 and 2: Continuous Pemigatinib 13.5 mg QD
- regimen
- Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Parts 1 and 2: Continuous Pemigatinib 20 mg QD
- regimen
- Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Part 1: Continuous Pemigatinib 7.5 mg BID
- regimen
- Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0000
- arm key
- OG009
- arm label
- Part 1: Continuous Pemigatinib 10 mg BID
- regimen
- Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0000#groups/OG009
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg
- regimen
- Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m\^2) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg
- regimen
- Participants received gemcitabine intravenously starting at 1000 mg/m\^2 on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02393248-om-0001#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG000
- source section id
- NCT02393248-ae
- event group key
- EG000
- event group label
- Part 1: Intermittent Pemigatinib 1/2/4 mg QD
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG001
- source section id
- NCT02393248-ae
- event group key
- EG001
- event group label
- Part 1: Intermittent Pemigatinib 6 mg QD
- serious affected
- 0
- serious at risk
- 4
- other affected
- 3
- other at risk
- 4
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG002
- source section id
- NCT02393248-ae
- event group key
- EG002
- event group label
- Parts 1 and 2: Intermittent Pemigatinib 9 mg QD
- serious affected
- 3
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG003
- source section id
- NCT02393248-ae
- event group key
- EG003
- event group label
- Parts 1 and 2: Intermittent Pemigatinib 13.5 mg QD
- serious affected
- 21
- serious at risk
- 50
- other affected
- 50
- other at risk
- 50
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG004
- source section id
- NCT02393248-ae
- event group key
- EG004
- event group label
- Part 1: Intermittent Pemigatinib 20 mg QD
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG005
- source section id
- NCT02393248-ae
- event group key
- EG005
- event group label
- Parts 1 and 2: Continuous Pemigatinib 9 mg QD
- serious affected
- 6
- serious at risk
- 14
- other affected
- 14
- other at risk
- 14
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG006
- source section id
- NCT02393248-ae
- event group key
- EG006
- event group label
- Parts 1 and 2: Continuous Pemigatinib 13.5 mg QD
- serious affected
- 14
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG007
- source section id
- NCT02393248-ae
- event group key
- EG007
- event group label
- Parts 1 and 2: Continuous Pemigatinib 20 mg QD
- serious affected
- 7
- serious at risk
- 15
- other affected
- 15
- other at risk
- 15
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG008
- source section id
- NCT02393248-ae
- event group key
- EG008
- event group label
- Part 1: Continuous Pemigatinib 7.5 mg BID
- serious affected
- 2
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG009
- source section id
- NCT02393248-ae
- event group key
- EG009
- event group label
- Part 1: Continuous Pemigatinib 10 mg BID
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG010
- source section id
- NCT02393248-ae
- event group key
- EG010
- event group label
- Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg
- serious affected
- 1
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT02393248
- harm key
- EG011
- source section id
- NCT02393248-ae
- event group key
- EG011
- event group label
- Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg
- serious affected
- 3
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 5
- collection period
- up to 869 days
- event definition
- Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice