Trial Outcomes & Findings for Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer (NCT NCT03759600)
NCT ID: NCT03759600
Last Updated: 2024-07-16
Results Overview
ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST v.1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Until disease progression or death (Up to 3.8 years)
Results posted on
2024-07-16
Participant Flow
Participants took part in the study at 17 investigative sites in Japan from 26 December 2018 to 28 December 2022.
Female participants with a diagnosis of advanced, relapsed, high-grade serious epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based therapy were enrolled to receive niraparib 300 mg in this study.
Participant milestones
| Measure |
Niraparib 300 mg
Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Niraparib 300 mg
Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Progressive Disease
|
15
|
|
Overall Study
Site Terminated by Sponsor
|
3
|
Baseline Characteristics
Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
20 Participants
n=5 Participants
|
|
Time from First Diagnosis to First Dose
|
4.71 years
n=5 Participants
|
|
Primary Tumor Site
Ovarian
|
13 Participants
n=5 Participants
|
|
Primary Tumor Site
Primary Peritoneal
|
5 Participants
n=5 Participants
|
|
Primary Tumor Site
Fallopian Tube
|
2 Participants
n=5 Participants
|
|
Cancer Stage (FIGO) at Time of Initial Diagnosis
IA
|
1 Participants
n=5 Participants
|
|
Cancer Stage (FIGO) at Time of Initial Diagnosis
IC
|
1 Participants
n=5 Participants
|
|
Cancer Stage (FIGO) at Time of Initial Diagnosis
IIB
|
1 Participants
n=5 Participants
|
|
Cancer Stage (FIGO) at Time of Initial Diagnosis
IIC
|
1 Participants
n=5 Participants
|
|
Cancer Stage (FIGO) at Time of Initial Diagnosis
IIIA
|
1 Participants
n=5 Participants
|
|
Cancer Stage (FIGO) at Time of Initial Diagnosis
IIIC
|
12 Participants
n=5 Participants
|
|
Cancer Stage (FIGO) at Time of Initial Diagnosis
IV
|
3 Participants
n=5 Participants
|
|
Height
|
155.9 centimeters (cm)
STANDARD_DEVIATION 5.78 • n=5 Participants
|
|
Weight
|
53.70 kilograms (kg)
STANDARD_DEVIATION 9.701 • n=5 Participants
|
|
Body Mass Index (BMI)
|
22.12 kilograms per meter square (kg/m^2)
STANDARD_DEVIATION 4.074 • n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
15 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
5 Participants
n=5 Participants
|
|
Number of Prior Lines of Chemotherapy
3
|
12 Participants
n=5 Participants
|
|
Number of Prior Lines of Chemotherapy
4
|
8 Participants
n=5 Participants
|
|
Prior Taxane
Participants Who Received Taxane
|
20 Participants
n=5 Participants
|
|
Prior Bevacizumab
Participants Who Received Bevacizumab
|
10 Participants
n=5 Participants
|
|
Prior Bevacizumab
Participants Who Did Not Receive Bevacizumab
|
10 Participants
n=5 Participants
|
|
Prior Doxorubicin
Participants Who Received Doxorubicin
|
9 Participants
n=5 Participants
|
|
Prior Doxorubicin
Participants Who Did Not Receive Doxorubicin
|
11 Participants
n=5 Participants
|
|
Prior Liposomal Doxorubicin
Participants Who Did Not Receive Liposomal Doxorubicin
|
20 Participants
n=5 Participants
|
|
Prior Gemcitabine
Participants Who Received Gemcitabine
|
11 Participants
n=5 Participants
|
|
Prior Gemcitabine
Participants Who Did Not Receive Gemcitabine
|
9 Participants
n=5 Participants
|
|
Duration between the End Date of the Last Chemotherapy Regimen and the First Dose of Study Treatment
|
2.1 months
n=5 Participants
|
|
Duration between End Date of the Last Platinum-based Therapy and the First Dose of Study Treatment
|
16.3 months
n=5 Participants
|
|
Prior Surgery/Procedure for Study Indication
Participants Who Had Prior Surgery
|
20 Participants
n=5 Participants
|
|
Number of Prior Surgery/Procedure for Study Indication
|
2.3 surgery
STANDARD_DEVIATION 1.34 • n=5 Participants
|
|
Prior Radiation Therapy Related to the Study Indication
Had Radiation Therapy
|
2 Participants
n=5 Participants
|
|
Prior Radiation Therapy Related to the Study Indication
Had No Radiation Therapy
|
18 Participants
n=5 Participants
|
|
Response to Last Platinum-based Therapy
Complete Response (CR)
|
9 Participants
n=5 Participants
|
|
Response to Last Platinum-based Therapy
Partial Response (PR)
|
8 Participants
n=5 Participants
|
|
Response to Last Platinum-based Therapy
Stable Disease (SD)
|
2 Participants
n=5 Participants
|
|
Response to Last Platinum-based Therapy
Unknown
|
1 Participants
n=5 Participants
|
|
Time to Progression after the Last Platinum Therapy
6-12 Month
|
12 Participants
n=5 Participants
|
|
Time to Progression after the Last Platinum Therapy
More Than 12 Month
|
8 Participants
n=5 Participants
|
|
Ovarian Cancer Pathology Histological: Histologic Subtype
Serous
|
20 Participants
n=5 Participants
|
|
Ovarian Cancer Pathology Histological: Histologic Subtype
Endometrioid
|
0 Participants
n=5 Participants
|
|
Ovarian Cancer Pathology Histological: Histologic Subtype
Mucinous
|
0 Participants
n=5 Participants
|
|
Ovarian Cancer Pathology Histological: Histologic Subtype
Other
|
0 Participants
n=5 Participants
|
|
Ovarian Cancer Pathology Histological: Tumor Grade
Grade 2
|
1 Participants
n=5 Participants
|
|
Ovarian Cancer Pathology Histological: Tumor Grade
Grade 3
|
6 Participants
n=5 Participants
|
|
Ovarian Cancer Pathology Histological: Tumor Grade
High Grade
|
13 Participants
n=5 Participants
|
|
Germline Breast Cancer (Gene) (BRCA1) Mutant
Without Mutant
|
3 Participants
n=5 Participants
|
|
Germline Breast Cancer (Gene) (BRCA1) Mutant
Unknown
|
17 Participants
n=5 Participants
|
|
Germline BRCA2 Mutant
Without Mutant
|
3 Participants
n=5 Participants
|
|
Germline BRCA2 Mutant
Unknown
|
17 Participants
n=5 Participants
|
|
Homologous Recombination Deficiency/Deficient (HRD) Companion Diagnostic (CDx) Test Result
Positive
|
20 Participants
n=5 Participants
|
|
Genomic Instability Status
Positive
|
17 Participants
n=5 Participants
|
|
Genomic Instability Status
Unknown
|
3 Participants
n=5 Participants
|
|
Tumor BRCA1/BRCA2 Mutation Status
Negative
|
6 Participants
n=5 Participants
|
|
Tumor BRCA1/BRCA2 Mutation Status
Positive
|
13 Participants
n=5 Participants
|
|
Tumor BRCA1/BRCA2 Mutation Status
Unknown
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until disease progression or death (Up to 3.8 years)Population: FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.
ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST v.1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Objective Response Rate (ORR)
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: Until disease progression or death (Up to 3.8 years)Population: FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline. Only Responders were analyzed for this outcome measure.
DOR was defined as the time from the first documented CR or PR per RECIST v.1.1 to disease recurrence or objective disease progression whichever occurs first. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD.
Outcome measures
| Measure |
Niraparib 300 mg
n=12 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Duration of Response (DOR)
|
9.9 months
Interval 3.9 to
Upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Until disease progression or death (Up to 3.8 years)Population: FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.
DCR was defined as the percentage of participants achieving CR, PR or SD as assessed by the Investigator per RECIST v.1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Disease Control Rate (DCR)
|
90.0 percentage of participants
Interval 68.302 to 98.765
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
20 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Number of Participants With Grade 3 or Higher TEAEs
|
17 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Number of Participants With Serious TEAEs
|
8 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Number of Participants With TEAEs Leading to Drug Discontinuation
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Number of Participants With TEAEs Leading to Dose Interruption
|
15 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Number of Participants With TEAEs Leading to Dose Reduction
|
16 Participants
|
SECONDARY outcome
Timeframe: Until disease progression or death (Up to 3.8 years)Population: FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.
PFS was defined as the time in months from the date of first study drug administration to the date of first documentation of PD or death as assessed by the RECIST v.1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Progression Free Survival (PFS)
|
8.3 months
Interval 5.6 to 13.8
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)Population: FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.
OS was defined as the time in months from the study enrollment to death due to any cause.
Outcome measures
| Measure |
Niraparib 300 mg
n=20 Participants
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Overall Survival (OS)
|
24.9 months
Interval 14.9 to
Upper limit of 95% CI was not estimable due to low number of participants with events.
|
Adverse Events
Niraparib 300mg
Serious events: 8 serious events
Other events: 20 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Niraparib 300mg
n=20 participants at risk
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Embolism
|
5.0%
1/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ileus
|
5.0%
1/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.0%
1/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
5.0%
1/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Niraparib 300mg
n=20 participants at risk
Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment cycle for up to 50 cycles.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
3/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
70.0%
14/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
20.0%
4/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
45.0%
9/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
5/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
4/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
4/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
35.0%
7/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
30.0%
6/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
30.0%
6/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
12/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count decreased
|
30.0%
6/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.0%
3/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
20.0%
4/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
50.0%
10/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
3/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
5/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
8/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
20.0%
4/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
30.0%
6/20 • From first dose of study drug up to 30 days after the last dose or beginning of subsequent anticancer therapy, whichever came first (Up to 3.8 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place