Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
Study Details
Study Description
Brief Summary
The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical benefit from the treatment with ASP2215, and who did not meet any of the study discontinuation criteria in the present study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gilteritinib 40 mg Participants received gilteritinib 40 milligrams (mg) dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria. |
Drug: Gilteritinib
oral tablet
Other Names:
|
| Experimental: Gilteritinib 80 mg Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria. |
Drug: Gilteritinib
oral tablet
Other Names:
|
| Experimental: Gilteritinib 120 mg Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria. |
Drug: Gilteritinib
oral tablet
Other Names:
|
| Experimental: Gilteritinib 200 mg Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria. |
Drug: Gilteritinib
oral tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events [From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)]
AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) [EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days)]
ECOG performance status was used to assess participants disease progression, and ability to carry out the daily living activities. The participants were graded on a scale of 0 to 5 where 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = capable of only limited self-care,confined to bed or chair more than 50% of waking hours; 4 = completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5 = Dead. Number of participants with ECOG performance status was reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject must currently be participating in an Astellas sponsored, single agent ASP2215 trial, receiving ASP2215 and have not met any discontinuation criteria of the parent study and can enroll into this rollover study without interruption of study drug, or with no more than 2 weeks interruption in study drug.
-
Subject must be deriving benefit from continued treatment without any persistent intolerable toxicity from continued treatment of ASP2215.
-
Female subject must either:
-
Be of non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile or post-hysterectomy (at least 1 month prior to Screening)
-
Or, if of childbearing potential, Agree not to try to become pregnant during the study and for 180 days after the final study drug administration; And have a negative urine pregnancy test at Day 1; And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 180 days after the final study drug administration.
-
Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
-
Female subject must not donate ova starting at Screening and throughout the study period, and for 180 days after the final study drug administration.
-
Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 120 days after the final study drug administration.
-
Male subject must not donate sperm starting at Screening and throughout the study period and, for 120 days after the final study drug administration.
-
Subject agrees not to participate in another interventional study while on treatment.
Exclusion Criteria:
-
Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
-
Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
-
Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site US10005 | Phoenix | Arizona | United States | 85084 |
| 2 | Site US10003 | Baltimore | Maryland | United States | 21201 |
| 3 | Site US10006 | New York | New York | United States | 10032 |
| 4 | Site US10007 | New York | New York | United States | 10065 |
| 5 | Site US10001 | Cleveland | Ohio | United States | 44195 |
| 6 | Site US10004 | Hershey | Pennsylvania | United States | 17033 |
| 7 | Site US10008 | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Astellas Pharma Global Development, Inc.
Investigators
- Study Director: Executive Medical Director, Astellas Pharma Global Development, Inc.
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 2215-CL-0109
Study Results
Participant Flow
| Recruitment Details | Participants from previosuly conducted ASP2215 trial were recruited to receive gilteritinib at a dose specified at the time of their end of study visit in the previous ASP2215 study. |
|---|---|
| Pre-assignment Detail | Participants with Acute myeloid leukemia (AML) and advanced solid tumors who completed the protocol requirements of the previous ASP2215 trial (NCT02014558 and NCT02456883) were included in this study. 9 participants were screened. |
| Arm/Group Title | Gilteritinib 40 mg | Gilteritinib 80 mg | Gilteritinib 120 mg | Gilteritinib 200 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received gilteritinib 40 milligrams (mg) dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| Period Title: Overall Study | ||||
| STARTED | 2 | 3 | 3 | 1 |
| COMPLETED | 0 | 1 | 0 | 0 |
| NOT COMPLETED | 2 | 2 | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Gilteritinib 40 mg | Gilteritinib 80 mg | Gilteritinib 120 mg | Gilteritinib 200 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Total of all reporting groups |
| Overall Participants | 2 | 3 | 3 | 1 | 9 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
47.5
(17.7)
|
41
(17.5)
|
55.7
(12.1)
|
31.0
|
46.2
(15.0)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
2
100%
|
1
33.3%
|
2
66.7%
|
1
100%
|
6
66.7%
|
| Male |
0
0%
|
2
66.7%
|
1
33.3%
|
0
0%
|
3
33.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
1
11.1%
|
| Not Hispanic or Latino |
2
100%
|
2
66.7%
|
3
100%
|
1
100%
|
8
88.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
2
100%
|
3
100%
|
3
100%
|
1
100%
|
9
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants) | |||||
| Grade 0 |
1
50%
|
2
66.7%
|
0
0%
|
1
100%
|
4
44.4%
|
| Grade 1 |
1
50%
|
1
33.3%
|
3
100%
|
0
0%
|
5
55.6%
|
Outcome Measures
| Title | Number of Participants With Adverse Events |
|---|---|
| Description | AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator. |
| Time Frame | From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the SAF were analyzed. |
| Arm/Group Title | Gilteritinib 40 mg | Gilteritinib 80 mg | Gilteritinib 120 mg | Gilteritinib 200 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| Measure Participants | 2 | 3 | 3 | 1 |
| Count of Participants [Participants] |
2
100%
|
3
100%
|
3
100%
|
1
100%
|
| Title | Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT) |
|---|---|
| Description | ECOG performance status was used to assess participants disease progression, and ability to carry out the daily living activities. The participants were graded on a scale of 0 to 5 where 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = capable of only limited self-care,confined to bed or chair more than 50% of waking hours; 4 = completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5 = Dead. Number of participants with ECOG performance status was reported. |
| Time Frame | EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the SAF with available data were analyzed. |
| Arm/Group Title | Gilteritinib 40 mg | Gilteritinib 80 mg | Gilteritinib 120 mg | Gilteritinib 200 mg |
|---|---|---|---|---|
| Arm/Group Description | Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. |
| Measure Participants | 2 | 3 | 1 | 1 |
| Grade 0 |
2
100%
|
0
0%
|
0
0%
|
0
0%
|
| Grade 1 |
0
0%
|
3
100%
|
0
0%
|
1
100%
|
| Grade 2 |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
| Grade 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Grade 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days) | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Gilteritinib 40 mg | Gilteritinib 80 mg | Gilteritinib 120 mg | Gilteritinib 200 mg | ||||
| Arm/Group Description | Participants received gilteritinib 40 mg dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occurred, or met one of the treatment discontinuation criteria. | ||||
All Cause Mortality |
||||||||
| Gilteritinib 40 mg | Gilteritinib 80 mg | Gilteritinib 120 mg | Gilteritinib 200 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | 0/3 (0%) | 0/3 (0%) | 0/1 (0%) | ||||
Serious Adverse Events |
||||||||
| Gilteritinib 40 mg | Gilteritinib 80 mg | Gilteritinib 120 mg | Gilteritinib 200 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/2 (100%) | 1/3 (33.3%) | 2/3 (66.7%) | 0/1 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Obstructive pancreatitis | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| General disorders | ||||||||
| Pyrexia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||||
| Appendicitis | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory syncytial virus infection | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Staphylococcal bacteraemia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Investigations | ||||||||
| Blood creatine phosphokinase increased | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Musculoskeletal pain | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Myositis | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Osteonecrosis | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/1 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Malignant melanoma | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Hypoxia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Respiratory failure | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypotension | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Gilteritinib 40 mg | Gilteritinib 80 mg | Gilteritinib 120 mg | Gilteritinib 200 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/2 (100%) | 3/3 (100%) | 3/3 (100%) | 1/1 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Cardiac disorders | ||||||||
| Sinus tachycardia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Eye disorders | ||||||||
| Accommodation disorder | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Dry eye | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Eye pain | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Trichiasis | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Vitreous detachment | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Abdominal distension | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Abdominal pain | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Anorectal discomfort | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Colitis | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Constipation | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 0/1 (0%) | 0 |
| Diarrhoea | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 5 | 1/1 (100%) | 1 |
| Dry mouth | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Haemorrhoids | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Nausea | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 3 | 0/1 (0%) | 0 |
| Oral mucosal hypertrophy | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Toothache | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| General disorders | ||||||||
| Chills | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/1 (0%) | 0 |
| Fatigue | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| Non-cardiac chest pain | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Pain | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| Pyrexia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 5 | 1/1 (100%) | 1 |
| Immune system disorders | ||||||||
| Chronic graft versus host disease in eye | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Chronic graft versus host disease oral | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||||
| Bronchitis | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| COVID-19 | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| Influenza | 1/2 (50%) | 3 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 1/1 (100%) | 1 |
| Klebsiella bacteraemia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Lip infection | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Nasopharyngitis | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Peritonitis | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Rhinovirus infection | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Sinusitis | 1/2 (50%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| Upper respiratory tract infection | 1/2 (50%) | 3 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Urinary tract infection | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Conjunctival abrasion | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Corneal abrasion | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Epicondylitis | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Fall | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Foot fracture | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/1 (100%) | 1 |
| Joint dislocation | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Procedural pain | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Skin laceration | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Tooth fracture | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Traumatic lung injury | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Wound | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| Investigations | ||||||||
| Blood cholesterol increased | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Blood creatine phosphokinase increased | 1/2 (50%) | 1 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Blood creatinine increased | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Blood insulin abnormal | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Blood lactate dehydrogenase increased | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Transaminases increased | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Weight increased | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 3 | 0/1 (0%) | 0 |
| Dehydration | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| Fluid overload | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Hyperuricaemia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Hypomagnesaemia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 3 | 0/1 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 1/2 (50%) | 2 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 0/1 (0%) | 0 |
| Arthritis | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Groin pain | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Joint effusion | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Joint range of motion decreased | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Muscle spasms | 2/2 (100%) | 2 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Myalgia | 1/2 (50%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Myopathy | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Myositis | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Osteopenia | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Tendonitis | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Acrochordon | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Basal cell carcinoma | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Benign breast neoplasm | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| Squamous cell carcinoma | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Nervous system disorders | ||||||||
| Carpal tunnel syndrome | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Cognitive disorder | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Dizziness | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Headache | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 1/1 (100%) | 1 |
| Lethargy | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Paraesthesia | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Syncope | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Tremor | 1/2 (50%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Anxiety | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Confusional state | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Insomnia | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Mood swings | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Dysuria | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Haematuria | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Erectile dysfunction | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 2/2 (100%) | 3 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 1/1 (100%) | 1 |
| Dyspnoea | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 3 | 1/1 (100%) | 1 |
| Dyspnoea exertional | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Paranasal sinus hypersecretion | 0/2 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Rhinorrhoea | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Dry skin | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Lentigo | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Rash maculo-papular | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
| Vascular disorders | ||||||||
| Hot flush | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Hypertension | 1/2 (50%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 |
| Hypotension | 0/2 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
"Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement."
Results Point of Contact
| Name/Title | Clinical Trial Disclosure |
|---|---|
| Organization | Astellas Pharma Global Development, Inc |
| Phone | 800-888-7704 |
| astellas.resultsdisclosure@astellas.com |
- 2215-CL-0109