Trial Outcomes & Findings for Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations (NCT NCT03773302)

Last Updated: 2024-05-08

Results Overview

Defined as the time from randomization until date of disease progression by blinded independent central imaging assessment (Response Evaluation Criteria in Solid Tumors \[RECIST\] v. 1.1) or death, whichever occurs first.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

48 participants

Primary outcome timeframe

From the time of randomization to end of treatment due to confirmed disease progression or death. Note: PFS is an event driven endpoint. Subjects without confirmed disease progression at the end of study were censored at their last valid tumor assessment.

Results posted on

2024-05-08

Participant Flow

Participants with a diagnosis of advanced/metastatic or inoperable cholangiocarcinoma (CCA) with FGFR2 fusion/rearrangement were recruited to this open-label, randomized, controlled global study across Western Europe, North America, and Asia, based on documented evidence of FGFR2 genetic alteration. The first participant was treated on 18 March 2020. The data cutoff for the analysis was 02 March 2023.

Subjects meeting inclusion/exclusion criteria were randomly assigned 2:1 to receive oral infigratinib 125 mg (N=29) or gemcitabine+cisplatin (N=19). Randomization was stratified by unresectable locally advanced vs metastatic disease, geographic region (North America, Western Europe, Asia Pacific, and rest of the world), prior neoadjuvant/adjuvant treatment (yes/no) and received up to 1 cycle of prior gemcitabine-based chemotherapy for unresectable locally advanced or metastatic disease (yes/no).

Participant milestones

Participant milestones
Measure	Infigratinib (BGJ398) 125 mg Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experienced disease progression while receiving gemcitabine + cisplatin were allowed to cross over and receive infigratinib.
Overall Study STARTED	29	19
Overall Study COMPLETED	29	17
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infigratinib (BGJ398) 125 mg n=29 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=19 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants	13 Participants n=4 Participants	34 Participants n=27 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Age, Continuous	54 years STANDARD_DEVIATION 13.22 • n=93 Participants	58.2 years STANDARD_DEVIATION 15.25 • n=4 Participants	55.8 years STANDARD_DEVIATION 14.04 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	10 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	9 Participants n=4 Participants	19 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	7 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants	14 Participants n=4 Participants	34 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment North America	12 participants n=93 Participants	7 participants n=4 Participants	19 participants n=27 Participants
Region of Enrollment Europe	14 participants n=93 Participants	8 participants n=4 Participants	22 participants n=27 Participants
Region of Enrollment Southeast Asia	3 participants n=93 Participants	4 participants n=4 Participants	7 participants n=27 Participants
BMI	28.41 kg/m2 STANDARD_DEVIATION 7.018 • n=93 Participants	26.83 kg/m2 STANDARD_DEVIATION 8.019 • n=4 Participants	27.79 kg/m2 STANDARD_DEVIATION 7.388 • n=27 Participants
ECOG PS 0	19 Participants n=93 Participants	8 Participants n=4 Participants	27 Participants n=27 Participants
ECOG PS 1	10 Participants n=93 Participants	11 Participants n=4 Participants	21 Participants n=27 Participants
ECOG PS 2	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Primary site of cholangiocarcinoma Common bile duct	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Primary site of cholangiocarcinoma Intrahepatic bile duct	28 Participants n=93 Participants	17 Participants n=4 Participants	45 Participants n=27 Participants
Primary site of cholangiocarcinoma Other	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Histological subtype Adenocarcinoma	26 Participants n=93 Participants	19 Participants n=4 Participants	45 Participants n=27 Participants
Histological subtype Mixed adeno and squamous	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Histological subtype Other	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Initial tumor (T) diagnosis category TX	7 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants
Initial tumor (T) diagnosis category T0	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Initial tumor (T) diagnosis category Tis	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Initial tumor (T) diagnosis category T1	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Initial tumor (T) diagnosis category T2	10 Participants n=93 Participants	7 Participants n=4 Participants	17 Participants n=27 Participants
Initial tumor (T) diagnosis category T3	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Initial tumor (T) diagnosis category T4	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Initial metastasis (M) diagnosis category M0	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants
Initial metastasis (M) diagnosis category M1	21 Participants n=93 Participants	14 Participants n=4 Participants	35 Participants n=27 Participants
Initial metastasis (M) diagnosis category Missing	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Time from initial diagnosis to randomization	8.49 months STANDARD_DEVIATION 19.765 • n=93 Participants	11.77 months STANDARD_DEVIATION 20.582 • n=4 Participants	9.79 months STANDARD_DEVIATION 19.940 • n=27 Participants
FGFR2 Fusion - Local Fusion positive - fusion partner known	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
FGFR2 Fusion - Local Fusion positive - fusion partner unknown	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
FGFR2 Fusion - Local Fusion positive - intron rearrangement	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
FGFR2 Fusion - Local Fusion negative	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
FGFR2 Fusion - Local Missing	20 Participants n=93 Participants	11 Participants n=4 Participants	31 Participants n=27 Participants
FGFR2 Fusion - Central Fusion positive - fusion partner known	15 Participants n=93 Participants	10 Participants n=4 Participants	25 Participants n=27 Participants
FGFR2 Fusion - Central Fusion positive - fusion partner unknown	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
FGFR2 Fusion - Central Fusion positive - intron rearrangement	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
FGFR2 Fusion - Central Fusion negative	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
FGFR2 Fusion - Central Missing	12 Participants n=93 Participants	9 Participants n=4 Participants	21 Participants n=27 Participants

PRIMARY outcome

Timeframe: From the time of randomization to end of treatment due to confirmed disease progression or death. Note: PFS is an event driven endpoint. Subjects without confirmed disease progression at the end of study were censored at their last valid tumor assessment.

Outcome measures

Outcome measures
Measure	Infigratinib (BGJ398) 125 mg n=12 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=7 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	ORR by Central Assessment Gemcitabine + Cisplatin	ORR by Investigator Assessment Gemcitabine + Cisplatin
Progression-free Survival (Central Imaging Assessment)	7.39 Months Interval 0.03 to 12.85	8.02 Months Interval 0.03 to 12.88	—	—

SECONDARY outcome

Timeframe: From the time of randomization to time of death. Note: OS is an event driven endpoint. Subjects who had not died (no record of death) or were lost to follow-up were censored at the date of last known to be alive.

OS by investigator assessment, defined as time from date of randomization until death due to any cause

Outcome measures

Outcome measures
Measure	Infigratinib (BGJ398) 125 mg n=8 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=3 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	ORR by Central Assessment Gemcitabine + Cisplatin	ORR by Investigator Assessment Gemcitabine + Cisplatin
Overall Survival (OS) in Participants Treated With Infigratinib Versus Gemcitabine With Cisplatin	NA Months Interval 14.36 to OS is an event driven endpoint. The number of events required to assess OS could not be calculated due to early termination of the study.	NA Months Interval 8.02 to OS is an event driven endpoint. The number of events required to assess OS could not be calculated due to early termination of the study.	—	—

SECONDARY outcome

Defined as the time from randomization until date of disease progression by site investigator (RECIST v1.1) or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	Infigratinib (BGJ398) 125 mg n=19 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=8 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	ORR by Central Assessment Gemcitabine + Cisplatin	ORR by Investigator Assessment Gemcitabine + Cisplatin
Investigator Assessed Progression Free Survival in Participants Treated With Infigratinib Compared to Gemcitabine and Cisplatin	7.39 Months Interval 0.03 to 20.24	5.19 Months Interval 0.03 to 12.88	—	—

SECONDARY outcome

Timeframe: From the time of randomization to end of study treatment (an average of approx.6.5 months [max: 23 months] for the infigratinib arm and approx. 4 months [max: 11-13 months] for the gemcitabine + cisplatin arm up to the time of termination of the study).

Population: Intent-to-treat (ITT)

ORR is defined as the proportion of subjects with a best overall response (BOR) of either confirmed partial response (PR) or confirmed complete response (CR) as assessed by BICR and the investigator according to RECIST v1.1 among patients with measurable disease at baseline

Outcome measures

Outcome measures
Measure	Infigratinib (BGJ398) 125 mg n=29 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=29 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	ORR by Central Assessment n=19 Participants Gemcitabine + Cisplatin	ORR by Investigator Assessment n=19 Participants Gemcitabine + Cisplatin
Overall Response Rate (ORR) Determined by Blinded Independent Central (BICR) and Investigator Assessment	11 Participants	9 Participants	3 Participants	2 Participants

SECONDARY outcome

Population: ITT

BOR was defined as the best response a subject ever achieved after study treatment prior to crossover and any subsequent anticancer therapy, complete response (CR) and partial response (PR) were claimed only if the criteria for each were met at a subsequent time point at least 4 weeks apart. In the case of stable disease (SD), measurements must have met the SD criteria at least once post-baseline no less than 6 weeks from the randomization date.

Outcome measures

Outcome measures
Measure	Infigratinib (BGJ398) 125 mg n=29 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=29 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	ORR by Central Assessment n=19 Participants Gemcitabine + Cisplatin	ORR by Investigator Assessment n=19 Participants Gemcitabine + Cisplatin
Best Overall Response (BOR) Determined by Blinded Independent Central Assessment and the Investigator. Confirmed complete response	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response (BOR) Determined by Blinded Independent Central Assessment and the Investigator. Confirmed partial response	11 Participants	9 Participants	3 Participants	2 Participants
Best Overall Response (BOR) Determined by Blinded Independent Central Assessment and the Investigator. Stable disease	14 Participants	19 Participants	11 Participants	12 Participants
Best Overall Response (BOR) Determined by Blinded Independent Central Assessment and the Investigator. Progressive disease	2 Participants	0 Participants	2 Participants	3 Participants
Best Overall Response (BOR) Determined by Blinded Independent Central Assessment and the Investigator. Not done	2 Participants	1 Participants	3 Participants	2 Participants

SECONDARY outcome

Population: ITT.

DOR is defined as the time from initiation of confirmed partial response (PR) or confirmed complete response (CR) to the time of confirmed progressive disease (PD) or death. If subjects do not reach PD or death before crossover, the DOR is censored at the last valid tumor assessment before crossover.

Outcome measures

Outcome measures
Measure	Infigratinib (BGJ398) 125 mg n=29 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=29 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	ORR by Central Assessment n=19 Participants Gemcitabine + Cisplatin	ORR by Investigator Assessment n=19 Participants Gemcitabine + Cisplatin
Duration of Response (DOR) Determined by Blinded Independent Central Assessment and the Investigator.	5.59 Months Interval 3.71 to DOR is an event driven endpoint. The number of events required to assess the DOR could not be calculated due to early termination of the study.	7.52 Months Interval 3.71 to DOR is an event driven endpoint. The number of events required to assess the DOR could not be calculated due to early termination of the study.	NA Months Interval 3.94 to DOR is an event driven endpoint. The number of events required to assess the DOR could not be calculated due to early termination of the study.	NA Months Interval 8.08 to DOR is an event driven endpoint. The number of events required to assess the DOR could not be calculated due to early termination of the study.

SECONDARY outcome

Population: ITT

DCR is defined as the proportion of subjects with a best overall response (BOR) of either confirmed partial response (PR), confirmed complete response (CR) or stable disease (SD) or non-CR/non-PD before crossover.

Outcome measures

Outcome measures
Measure	Infigratinib (BGJ398) 125 mg n=29 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=29 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	ORR by Central Assessment n=19 Participants Gemcitabine + Cisplatin	ORR by Investigator Assessment n=19 Participants Gemcitabine + Cisplatin
Disease Control Rate (DCR=PR+CR+SD) Determined by Blinded Independent Central Assessment and the Investigator.	25 Participants	28 Participants	14 Participants	14 Participants

SECONDARY outcome

Timeframe: From baseline to last dose date of study treatment + 30 days (an average of 7.5 months for the infigratinib arm and 5 months for the gemcitabine + cisplatin arm).

Population: Safety

Safety analyses were performed for subjects in the safety analysis population for each group. Unless otherwise specified, summaries were provided only for the on-treatment safety assessments, which are the assessments occurring or taken during the on-treatment period

Outcome measures

Outcome measures
Measure	Infigratinib (BGJ398) 125 mg n=29 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=17 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	ORR by Central Assessment Gemcitabine + Cisplatin	ORR by Investigator Assessment Gemcitabine + Cisplatin
Number of Participants With Adverse Events (AEs)	29 Participants	17 Participants	—	—

SECONDARY outcome

Timeframe: From baseline to last dose date of study treatment + 30 days (an average of 7.5 months for the infigratinib arm and 5 months for the gemcitabine + cisplatin arm).

Population: Safety

Outcome measures

Outcome measures
Measure	Infigratinib (BGJ398) 125 mg n=29 Participants Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=17 Participants Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.	ORR by Central Assessment Gemcitabine + Cisplatin	ORR by Investigator Assessment Gemcitabine + Cisplatin
Number of Participants With Serious Adverse Events (SAEs)	10 Participants	0 Participants	—	—

Adverse Events

Infigratinib (BGJ398) 125 mg

Serious events: 10 serious events

Other events: 29 other events

Deaths: 0 deaths

Gemcitabine + Cisplatin

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infigratinib (BGJ398) 125 mg n=29 participants at risk Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.	Gemcitabine + Cisplatin n=17 participants at risk Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle.
Eye disorders Eye pain	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Gastrointestinal disorders Stomatitis	6.9% 2/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Gastrointestinal disorders Dysphagia	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
General disorders Fatigue	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Infections and infestations COVID-19	6.9% 2/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Infections and infestations Sepsis	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Metabolism and nutrition disorders Calciphylaxis	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Metabolism and nutrition disorders Hypercalcaemia	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Metabolism and nutrition disorders Hyperphosphataemia	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Metabolism and nutrition disorders Hypokalaemia	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Musculoskeletal and connective tissue disorders Pain in extremity	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypercalcaemia of malignancy	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Nervous system disorders Dizziness	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.
Skin and subcutaneous tissue disorders Erythema nodosum	3.4% 1/29 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.	0.00% 0/17 • From the the time of the first administration of study treatment through 30 days after their last dose. Treatment-emergent adverse events (TEAEs) includes any AE that have onset on or after the first study treatment, and before or on either: (1) the date of data cutoff if subject was ongoing the initial study treatment; (2) the earlier of the date of last study treatment +30 days or the date of crossover if the subject received infigratinib in crossover.

Other adverse events

Additional Information

Acting Chief Medical Officer

QED Therapeutics, Inc.

Phone: 1-877-280-5655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place