Trial Outcomes & Findings for Lenvatinib and Pembrolizumab Simultaneous Combination Study (NCT NCT03609359)
NCT ID: NCT03609359
Last Updated: 2025-04-16
Results Overview
ORR will be defined as the proportion of patients who achieved Complete Response (CR) or Partial Response (PR) for best overall response (confirmation required) according to immune-related RECIST (irRECIST) and RECIST v1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
12 months
Results posted on
2025-04-16
Participant Flow
Participant milestones
| Measure |
Lenvatinib + Pembrolizumab
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Lenvatinib + Pembrolizumab
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
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|---|---|
|
Overall Study
Progression of primary disease (PD)
|
25
|
|
Overall Study
Patient's refusal
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
The protocol treatment was discontinued for undergoing primary tumor resection.
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lenvatinib + Pembrolizumab
n=29 Participants
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=29 Participants
|
|
Age, Continuous
|
70 years
n=29 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=29 Participants
|
|
Region of Enrollment
Japan
|
29 participants
n=29 Participants
|
|
Primary site
Gastric adenocarcinoma
|
25 participants
n=29 Participants
|
|
Primary site
Gastroesophageal junction adenocarcinoma
|
4 participants
n=29 Participants
|
|
Lauren classification
Intestinal type
|
15 participants
n=29 Participants
|
|
Lauren classification
Diffuse type
|
14 participants
n=29 Participants
|
|
Mismatch Repair (MMR)
Proficient
|
27 participants
n=29 Participants
|
|
Mismatch Repair (MMR)
Deficient
|
2 participants
n=29 Participants
|
|
Number of metastatic organs
0
|
0 participants
n=29 Participants
|
|
Number of metastatic organs
1 piece
|
11 participants
n=29 Participants
|
|
Number of metastatic organs
2 pieces
|
14 participants
n=29 Participants
|
|
Number of metastatic organs
3 pieces
|
3 participants
n=29 Participants
|
|
Number of metastatic organs
4 pieces
|
1 participants
n=29 Participants
|
|
Peritoneal metastasis
Absent
|
20 participants
n=29 Participants
|
|
Peritoneal metastasis
Present
|
9 participants
n=29 Participants
|
|
Number of prior treatment regimens
0
|
14 participants
n=29 Participants
|
|
Number of prior treatment regimens
1
|
15 participants
n=29 Participants
|
|
Number of prior treatment regimens
2
|
0 participants
n=29 Participants
|
|
Number of prior treatment regimens
3
|
0 participants
n=29 Participants
|
|
Number of prior treatment regimens
4
|
0 participants
n=29 Participants
|
|
Programmed death-Ligand 1 (PD-L1)
Positive
|
26 participants
n=29 Participants
|
|
Programmed death-Ligand 1 (PD-L1)
Negative
|
3 participants
n=29 Participants
|
|
Epstein Barr Virus (EBV)
Positive
|
1 participants
n=29 Participants
|
|
Epstein Barr Virus (EBV)
Negative
|
28 participants
n=29 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: ORR will be defined as the proportion of patients who achieved CR or PR for best overall response (confirmation required) according to immune-related RECIST (irRECIST) and RECIST v1.1.
ORR will be defined as the proportion of patients who achieved Complete Response (CR) or Partial Response (PR) for best overall response (confirmation required) according to immune-related RECIST (irRECIST) and RECIST v1.1.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=29 Participants
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
|
|---|---|
|
Objective Response Rate (ORR)
Stable disease (SD)
|
9 Participants
|
|
Objective Response Rate (ORR)
Progressive disease (PD)
|
0 Participants
|
|
Objective Response Rate (ORR)
Complete Response (CR)
|
1 Participants
|
|
Objective Response Rate (ORR)
Partial Response (PR)
|
19 Participants
|
|
Objective Response Rate (ORR)
Not Evaluable (NE)
|
0 Participants
|
SECONDARY outcome
Timeframe: Basically 2 years, maximum 28 months* Number of each AE of the worst grade occurring in this study was evaluated based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 and tabulated throughout all cycles. This study also includes a special note regarding abnormal laboratory values. When clinical signs and symptoms observed in this study were elicited, diagnosis and related data were collected based on whether they were due to abnormal laboratory values. Therefore, for example, grading results for liver dysfunction may differ between non-hematologic toxicities and laboratory values. * Adverse-Events occurrences means "prevalence proportion" of any undesirable occurrence based on investigator's medical decision in this study.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=29 Participants
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
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|---|---|
|
Number of Participants With Adverse Events (AEs)
|
29 Participants
|
SECONDARY outcome
Timeframe: 12 monthsObjective response rate (irORR) according to immune-related (ir) RECIST
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=29 Participants
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
|
|---|---|
|
Objective Response Rate (irORR)
irSD
|
9 Participants
|
|
Objective Response Rate (irORR)
irPD
|
0 Participants
|
|
Objective Response Rate (irORR)
irNE
|
0 Participants
|
|
Objective Response Rate (irORR)
irCR
|
1 Participants
|
|
Objective Response Rate (irORR)
irPR
|
19 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm.
* 1 "Progression" will be PD based on diagnostic imaging according to overall response by RECIST v1.1. The day of the imaging test will be defined as the day of progression. When the treatment are discontinued due to clinical PD and diagnostic imaging can't be performed, the day of clinical PD will be defined as the day of progression. * 2 Surviving patients, who are not assessed as progression will be censored on the last day when no progression is confirmed on imaging (last day of PFS confirmed) * 3 For patients who died without being assessed as progression, whether to consider to be an "event on the day of death" or "censoring on the last day of PFS confirmed" should be decided at the time of data review performed prior to data fixation. In principle, they should be "an "event on the day of death" unless the period from the last day of PFS confirmed to the day of death is long.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=29 Participants
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
|
|---|---|
|
Progression-free Survival (PFS)
|
7.1 months
Interval 5.4 to 13.7
|
SECONDARY outcome
Timeframe: 28 months* The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause. Surviving patients should be censored on the last day of PFS confirmed. Patients who are lost to follow up should be censored on the last day when their survival is confirmed before being lost to follow up. * The protocol for this clinical trial stipulated that the observation period was "2 years from the date of registration of the last case." Meanwhile, OS was stipulated as "the period from the date of registration to the date of death from any cause. For surviving cases, the period was censored at the date of last confirmed survival." The observation period varied by case, with follow-up surveys lasting up to 28 months.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=29 Participants
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
|
|---|---|
|
Overall Survival (OS)
|
24.5 months
Interval 11.8 to
There were cases in which no events were confirmed within the observation period (2 years from the last registered case) specified in this clinical trial protocol, and the upper limit of the 95% confidence interval for median OS could not be estimated. Therefore, this is represented as "not estimable" in the Statistical Analysis Report (SAR).
To avoid system errors in this PRS system, the abbreviation "NA" was used for "not estimable."
|
SECONDARY outcome
Timeframe: 2 yearsThe DCR will be defined as the percentage of patients who achieved CR or PR, or Stable Disease (SD) for best overall response according to RECIST v1.1.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=29 Participants
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
|
|---|---|
|
Disease Control Rate (DCR)
|
100 percentage of participants
Interval 88.1 to 100.0
|
Adverse Events
Lenvatinib + Pembrolizumab
Serious events: 4 serious events
Other events: 29 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Lenvatinib + Pembrolizumab
n=29 participants at risk
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
|
|---|---|
|
Hepatobiliary disorders
Jaundice cholestatic
|
3.4%
1/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Cardiac disorders
Caridiac failure
|
3.4%
1/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Gastirc haemorrhage
|
3.4%
1/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Gastric perforation
|
3.4%
1/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
Other adverse events
| Measure |
Lenvatinib + Pembrolizumab
n=29 participants at risk
Lenvatinib and Pembrolizumab will be administrated simultaneously for advanced gastric cancer patients.
Lenvatinib: Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
Pembrolizumab: Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, every 3 weeks (25 minutes to 40 minutes are acceptable).
|
|---|---|
|
Gastrointestinal disorders
Ascities
|
10.3%
3/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.0%
9/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
13.8%
4/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Gingival pain
|
10.3%
3/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Nausea
|
13.8%
4/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Stomatitis
|
20.7%
6/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Vomitting
|
6.9%
2/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
General disorders
Influenza like illness
|
13.8%
4/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
General disorders
Malaise
|
34.5%
10/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
General disorders
Oedema peripheral
|
20.7%
6/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
General disorders
Pyrexia
|
24.1%
7/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Infections and infestations
Gingivitis
|
13.8%
4/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Infections and infestations
Lung infection
|
17.2%
5/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Hepatobiliary disorders
Livi disorder
|
13.8%
4/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
34.5%
10/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Blood and lymphatic system disorders
Anaemia
|
31.0%
9/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Vascular disorders
Hypertension
|
82.8%
24/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
10.3%
3/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.3%
3/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Nervous system disorders
Dizziness
|
6.9%
2/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Renal and urinary disorders
Proteinuria
|
55.2%
16/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Metabolism and nutrition disorders
Hypoalubuminaemia
|
27.6%
8/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
62.1%
18/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Endocrine disorders
Hypothyroidism
|
44.8%
13/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.9%
2/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaethesia syndrome
|
48.3%
14/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Skin and subcutaneous tissue disorders
Prurtinis
|
17.2%
5/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
27.6%
8/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Investigations
Alanine aminotransferase increased
|
20.7%
6/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Investigations
Amylase increased
|
10.3%
3/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Investigations
Asparate amintransferase increased
|
20.7%
6/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.3%
3/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Investigations
Neutrophil count decreased
|
10.3%
3/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Investigations
Platelet count decreased
|
27.6%
8/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Investigations
White blood cell count decreased
|
10.3%
3/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Investigations
Blood allkaline phosphatase incresed
|
17.2%
5/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Gastrointestinal disorders
Gastric stenosis
|
6.9%
2/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Psychiatric disorders
Insomnia
|
13.8%
4/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Endocrine disorders
Hyperthyroidism
|
6.9%
2/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Endocrine disorders
Hypopituitarism
|
6.9%
2/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
24.1%
7/29 • Basically 2 years, maximum 28 months
The AE evaluation period will be from the "the start day of the administration of the investigational drug" to "30 days after the day of the last dose of the investigational drug, or if subsequent treatment is initiated before that, before the start of the subsequent treatment, whichever comes earlier."AEs occurring this period will be collected. Even if it is 31 days after the last dose of the investigational drug, AEs assessed as related to the protocol treatment should be collected.
|
Additional Information
Dr.Kohei Shitara
National Cancer Center Hospital East
Phone: (+81)-4-7133-1111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place