Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma
Study Details
Study Description
Brief Summary
Background:
-
Alveolar soft part sarcoma is a type of cancer that develops in tissues that connect, support, or surround other organs in the body. It relies heavily on new blood vessels to grow and spread through the body. There is no effective systemic treatment for patients with alveolar soft part sarcoma.
-
The drug AZD2171 (cediranib) is an experimental drug, not yet approved by the Food and Drug Administration. The drug blocks the creation of new blood vessels. The drug has had initial clinical trials, and researchers are interested in determining whether cediranib is effective in inhibiting tumor growth in individuals who have alveolar soft part sarcoma.
Objectives:
- To find out whether AZD2171 works in patients who have alveolar soft part sarcoma.
Eligibility:
- Individuals 18 years of age and older who have been diagnosed with alveolar soft part sarcoma.
Design:
-
After an initial screening visit, patients will take AZD2171 by mouth once a day, every day for the duration of the study. The treatment will be given in 28-day cycles.
-
Patients will keep a study diary to record the doses taken, any missed doses, and any side effects.
-
Patients will have the following tests and procedures during the treatment period: clinic visit with physical examination every 2 weeks during cycles 1 and 2, then at the start of each subsequent cycle, regular blood pressure monitoring, blood and urine tests, heart function tests, imagining scans to evaluate tumor size and response to the treatment, and possible tumor biopsy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Background:
Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients with metastatic ASPS. Little is known with regards to relevant molecular markers as potential therapeutic targets. Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has recently demonstrated antitumor activity in early phase clinical trials, which included 7 adult and 3 pediatric patients with ASPS.
Objectives:
Adult patients:
-
To determine the response rate (Partial Response (PR) + Complete Response (CR)) of AZD2171 in adult patients with ASPS.
-
To compare gene expression profiles between pre-treatment and post-treatment biopsy specimens.
Pediatric patients:
-To determine if pediatric patients with ASPS will experience at least a minimal response rate when treated with AZD2171
Eligibility:
Patients must have histologically or cytologically confirmed metastatic alveolar soft part sarcoma.
-
Less than 16 years old. Body surface area (BSA) must be greater than or equal to 1.04 m^2 and subject must be able to swallow tablets.
-
Adequate organ function.
Design:
Adult patients will be treated with AZD2171 at 30 mg by mouth once a day for 28 days (28-day cycles). Pediatric patients (< 16 years old) will be treated with 12 mg/m^2/day once a day for 28 day (28-day cycles).
Blood pressure will be monitored weekly for the first 2 cycles then every 2 weeks for the remainder of the study (unless patients have experienced elevated blood pressure requiring drug therapy).
Computed tomography (CT) scans will be performed at baseline and every 2 cycles for restaging during the first 18 months; after 18 and 36 months, restaging CT scans will be performed every 3 or 4 cycles, respectively.
The study will be conducted using an optimal two-stage design in both pediatric and adult patients. The portion in adults will rule out an unacceptably low 5% clinical response rate (PR+CR) in favor of a modestly high response rate of 25%. In pediatric patients, the study will rule out an unacceptably low 5% overall clinical response rate (CR + PR) in favor of a higher response rate of 35%.
Optional biopsies will be performed in adult patients only at baseline and after 3-5 days of treatment (Day 3 (D3)-Day 5 (D5)) to evaluate early drug effect. A third optional biopsy after completion of 4 weeks of therapy (between Cycle 1 Day 28 (C1D28) and Cycle 2 Day 7 (C2D7)) may be collected with the intention of providing further information about disease response to treatment. Depending on results of initial gene expression profiles, the timing of the biopsies may be adjusted, but without change in total number of biopsies per patient.
In a retrospective pilot study, CT scans from 20 consecutive off-study patients will be re-reviewed. Response Evaluation Criteria in Solid Tumors (RECIST) imaging measurements will be compared to volumetric density (Total Volume of Viable Tumor, TVVT) CT measurements. The objective is to establish whether volumetric density/percent necrosis algorithms such as TVVT more accurately assess extent of disease and response to therapy than standard RECIST criteria.
The total accrual ceiling is 73 participants (60 adult and 13 pediatric patients).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cediranib (AZD2171) Treatment Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). |
Drug: AZD2171
Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS) [Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)]
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. A minimal response is defined as a 5% overall response rate (Partial Response (PR) + Complete Response (CR)
- Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS) [2 cycles (e.g., one cycle = 28 days)]
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all no-target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
- Number of Participants With a Best Observed Response [Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)]
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
- Number of Participants With a Best Response [Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)]
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Secondary Outcome Measures
- Number of Participants With Serious and Non-serious Adverse Events [Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days)]
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Eligibility Criteria
Criteria
- INCLUSION CRITERIA:
Patients must have histologically confirmed alveolar soft part sarcoma. Pathology should be confirmed at the Laboratory of Pathology, National Institutes of Health.
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 millimeters with conventional techniques or as greater than or equal to 10 millimeters with spiral computed tomography (CT) scan.
Patients must have metastatic alveolar soft part sarcoma that is not curable by surgery. Patients who have surgically resectable tumors with metastasis will be considered on a case by- case basis.
Any prior therapy must have been completed greater than or equal to 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity. Patients should be at least 6 weeks out from nitrosoureas and mitomycin C. Prior radiation should have been completed greater than or equal to 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels. Patients must be greater than or equal to 2 weeks since any investigational agent administered as part of a Phase 0 study (also referred to as an early Phase I study or pre-Phase I study where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI's) discretion, and should haverecovered to eligibility levels from any toxicities.
Any degree of prior treatment is allowed, including other anti-angiogenic treatments (e.g., vascular endothelial growth factor receptor 2 (VEGFR2) inhibitors or bevacizumab). Patients with no prior therapy are eligible, provided they have metastatic disease that is not curable by surgery.
Body surface area (BSA) greater than or equal to 1.04 square meter.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 for adults, Karnofsky performance status greater than or equal to 50% for pediatric patients greater than 10 years of age, and Lansky performance status greater than or equal to 50 for pediatric patients less than or equal to 10 years of age.
Life expectancy of greater than 8 weeks.
Patients must have normal organ and marrow function as defined below:
-
absolute neutrophil count greater than or equal to 1,500/microliter
-
platelets greater than or equal to 100,000/microliter
-
total bilirubin less than 1.5 times institutional upper limit of normal
-
Aspartate aminotransferase (AST)(Serum glutamic Oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (SGPT)) less than or equal to 2.5 times institutional upper limit of normal
-
creatinine within normal limits based on age as follows:
Age (Years) Maximum Serum Creatinine (milligrams per deciliter)
less than or equal to 5 0.8
5 less than age less than or equal to 10 1.0
10 less than age less than or equal to 15 1.2
greater than 15 1.5
OR
creatinine clearance greater than or equal to 60 milliliter/min for adults or greater than or equal to 60 milliliter/min/1.73m^2 for children with creatinine levels above institutional upper limit of normal.
Corrected QT interval (QTc) must be less than 500 msec.
Pediatric patients: Normal left ventricular function with ejection fraction greater than 55% or shortening fraction greater than or equal to 27%.
At present, the potential of Cediranib (AZD2171) for clinically significant drug interactions involving the cytochrome P450 (CYP) isozymes is unknown. However, studies of the agent in rats indicated possible suppression of cytochrome P450, family 1, subfamily A (CYP1A) that may be of biological significance. Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity of pharmacokinetics (PK) of AZD2171 will be determined following review of their case by the Principal Investigator. Efforts should be made to switch patients with brain metastases who are taking enzyme-inducing anticonvulsant agents to other medications one week prior to starting therapy.
AZD2171 has been shown to terminate fetal development in the rat, as expected for a process dependent on vascular endothelial growth factor (VEGF) signaling. For this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
Patients should not be receiving any other investigational agents.
Prior therapy with anti-angiogenic agents is permitted.
EXCLUSION CRITERIA:
Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to: active or uncontrolled infection, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements.
Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, ibuprofen, pentamidine).
Patients who are unable to swallow tablets.
Mean QTc greater than 500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long Q wave, T wave (QT) syndrome.
Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart.
Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with known abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2171, breastfeeding should be discontinued if the mother is treated with AZD2171.
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions with AZD2171.
Adult patients with hypertension not controlled by medical therapy (hypertension defined as systolic blood pressure greater than 150 millimeters of mercury or diastolic pressure greater than 90 millimeters of mercury despite optimal medical management). Pediatric patients must have blood pressure (BP) within normal limits (WNL) for age. NOTE: blood pressure within the upper limit of normal is defined as: blood pressure less than or equal to the 95th percentile for age, height, and gender, and measured, and not be receiving medication for treatment of hypertension.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Alice P Chen, M.D., National Cancer Institute (NCI)
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 090192
- 09-C-0192
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Adult Participants w/Alveolar Soft Part Sarcoma | Pediatric Participants w/Alveolar Soft Part Sarcoma |
|---|---|---|
| Arm/Group Description | Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). | Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). |
| Period Title: Overall Study | ||
| STARTED | 46 | 7 |
| COMPLETED | 1 | 3 |
| NOT COMPLETED | 45 | 4 |
Baseline Characteristics
| Arm/Group Title | Adult Participants w/Alveolar Soft Part Sarcoma | Pediatric Participants w/Alveolar Soft Part Sarcoma | Total |
|---|---|---|---|
| Arm/Group Description | Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). | Pediatric participants will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). | Total of all reporting groups |
| Overall Participants | 46 | 7 | 53 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
7
100%
|
7
13.2%
|
| Between 18 and 65 years |
46
100%
|
0
0%
|
46
86.8%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
30
|
13
|
21.5
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
50%
|
4
57.1%
|
27
50.9%
|
| Male |
23
50%
|
3
42.9%
|
26
49.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
8
17.4%
|
0
0%
|
8
15.1%
|
| Not Hispanic or Latino |
38
82.6%
|
7
100%
|
45
84.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
5
10.9%
|
0
0%
|
5
9.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
11
23.9%
|
3
42.9%
|
14
26.4%
|
| White |
25
54.3%
|
3
42.9%
|
28
52.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
5
10.9%
|
1
14.3%
|
6
11.3%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
46
100%
|
7
100%
|
53
100%
|
| Eastern Cooperative Oncology Group (ECOG) Status (Count of Participants) | |||
| 0 |
4
8.7%
|
4
57.1%
|
|
| 1 |
38
82.6%
|
38
542.9%
|
|
| 2 |
4
8.7%
|
4
57.1%
|
|
| Lansky/Karnofsky Performance Status (Count of Participants) | |||
| 100% |
1
2.2%
|
1
14.3%
|
|
| 90% |
4
8.7%
|
4
57.1%
|
|
| 80% |
2
4.3%
|
2
28.6%
|
|
| Prior Resection (Count of Participants) | |||
| Count of Participants [Participants] |
35
76.1%
|
3
42.9%
|
38
71.7%
|
| Prior Radiation (Count of Participants) | |||
| Count of Participants [Participants] |
27
58.7%
|
2
28.6%
|
29
54.7%
|
| Prior Systemic Therapy (Count of Participants) | |||
| Count of Participants [Participants] |
4
8.7%
|
4
57.1%
|
|
| Prior Systemic Therapies (Count of Participants) | |||
| 0 |
18
39.1%
|
4
57.1%
|
22
41.5%
|
| 1 |
18
39.1%
|
1
14.3%
|
19
35.8%
|
| 2 |
5
10.9%
|
0
0%
|
5
9.4%
|
| ≥3 |
5
10.9%
|
3
42.9%
|
8
15.1%
|
Outcome Measures
| Title | Minimal Response Rate in Pediatric Participants With Alveolar Soft Part Sarcoma (ASPS) |
|---|---|
| Description | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. A minimal response is defined as a 5% overall response rate (Partial Response (PR) + Complete Response (CR) |
| Time Frame | Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pediatric Participants w/Alveolar Soft Part Sarcoma |
|---|---|
| Arm/Group Description | Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). |
| Measure Participants | 7 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With a Response (Partial Response (PR) + Complete Response (CR)) of AZD2171 in Adult Participants With Alveolar Soft Part Sarcoma (ASPS) |
|---|---|
| Description | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all no-target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. |
| Time Frame | 2 cycles (e.g., one cycle = 28 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 45/46 participants were analyzed because one participant was not treated. |
| Arm/Group Title | Adult Participants w/Alveolar Soft Part Sarcoma |
|---|---|
| Arm/Group Description | Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). |
| Measure Participants | 45 |
| Complete Response |
0
0%
|
| Partial Response |
13
28.3%
|
| Title | Number of Participants With a Best Observed Response |
|---|---|
| Description | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. |
| Time Frame | Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pediatric Participants w/Alveolar Soft Part Sarcoma |
|---|---|
| Arm/Group Description | Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). |
| Measure Participants | 7 |
| Complete Response |
0
0%
|
| Partial Response |
0
0%
|
| Stable Disease |
5
10.9%
|
| Progressive Disease |
2
4.3%
|
| Title | Number of Participants With a Best Response |
|---|---|
| Description | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. |
| Time Frame | Date treatment initiated to date off study, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 45/46 participants were analyzed because one participant did not receive any treatment on the trial. |
| Arm/Group Title | Adult Participants w/Alveolar Soft Part Sarcoma |
|---|---|
| Arm/Group Description | Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). |
| Measure Participants | 45 |
| Complete Response |
0
0%
|
| Partial Response |
13
28.3%
|
| Stable Disease |
30
65.2%
|
| Progressive Disease |
2
4.3%
|
| Title | Number of Participants With Serious and Non-serious Adverse Events |
|---|---|
| Description | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Time Frame | Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adult Participants w/Alveolar Soft Part Sarcoma | Pediatric Participants w/Alveolar Soft Part Sarcoma |
|---|---|---|
| Arm/Group Description | Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). | Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). |
| Measure Participants | 46 | 7 |
| Count of Participants [Participants] |
45
97.8%
|
7
100%
|
Adverse Events
| Time Frame | Participants were followed for the duration of treatment, an average of 16.9 cycles for adult patients and 34.7 cycles for pediatric patients (1 cycle = 28 days) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Adult Participants w/Alveolar Soft Part Sarcoma | Pediatric Participants w/Alveolar Soft Part Sarcoma | ||
| Arm/Group Description | Adult participants will be treated with 30 mg by mouth once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). | Pediatric participants (<16 years old) will be treated with 12 mg/m^2/day once a day for 28 days (28-day cycles). AZD2171: Cediranib (AZD2171), a vascular endothelial growth factor (VEGF)/KIT tyrosine kinase inhibitor, has demonstrated antitumor activity in early phase clinical trials in adult and pediatric patients with Alveolar Soft Part Sarcoma (ASPS). | ||
All Cause Mortality |
||||
| Adult Participants w/Alveolar Soft Part Sarcoma | Pediatric Participants w/Alveolar Soft Part Sarcoma | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/46 (4.3%) | 0/7 (0%) | ||
Serious Adverse Events |
||||
| Adult Participants w/Alveolar Soft Part Sarcoma | Pediatric Participants w/Alveolar Soft Part Sarcoma | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/46 (47.8%) | 6/7 (85.7%) | ||
| Cardiac disorders | ||||
| Left ventricular systolic dysfunction | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Palpitations | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Sinus bradycardia | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Eye disorders | ||||
| Papilledema | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Diarrhea | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Dyspepsia | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Fever | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Gastroesophageal reflux disease | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Nausea | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| General disorders | ||||
| Sudden death NOS | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Infections and infestations | ||||
| Hepatitis viral | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Lung infection | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Paronychia | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Fracture | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Investigations | ||||
| Alanine aminotransferase increased | 3/46 (6.5%) | 3 | 1/7 (14.3%) | 1 |
| Alkaline phosphatase increased | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Aspartate aminotransferase increased | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Blood bilirubin increased | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| CPK increased | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Creatinine increased | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Lipase increased | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Neutrophil count decreased | 2/46 (4.3%) | 2 | 1/7 (14.3%) | 2 |
| Serum amylase increased | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| White blood cell decreased | 1/46 (2.2%) | 1 | 1/7 (14.3%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 3/46 (6.5%) | 3 | 0/7 (0%) | 0 |
| Hyponatremia | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Musculoskeletal and connective tissue disorder - Other, specify | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Tumor pain | 3/46 (6.5%) | 3 | 0/7 (0%) | 0 |
| Nervous system disorders | ||||
| Dizziness | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Headache | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Presyncope | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Syncope | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Psychiatric disorders | ||||
| Confusion | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Suicidal ideation | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Proteinuria | 5/46 (10.9%) | 7 | 1/7 (14.3%) | 1 |
| Reproductive system and breast disorders | ||||
| Pregnancy, puerperium and perinatal conditions - Other, Pregnancy | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Testicular disorder | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Atelectasis | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Bronchopulmonary hemorrhage | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Dyspnea | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Pneumothorax | 1/46 (2.2%) | 2 | 0/7 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders - Other, Asthma | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Surgical and medical procedures | ||||
| Surgical and medical procedures - Other, SCFE | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Vascular disorders | ||||
| Hypertension | 1/46 (2.2%) | 1 | 2/7 (28.6%) | 2 |
| Hypotension | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Adult Participants w/Alveolar Soft Part Sarcoma | Pediatric Participants w/Alveolar Soft Part Sarcoma | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 45/46 (97.8%) | 7/7 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 18/46 (39.1%) | 59 | 5/7 (71.4%) | 10 |
| Cardiac disorders | ||||
| Chest pain - cardiac | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Electrocardiogram QT corrected interval prolonged | 3/46 (6.5%) | 4 | 0/7 (0%) | 0 |
| Palpitations | 4/46 (8.7%) | 4 | 1/7 (14.3%) | 1 |
| Sinus bradycardia | 2/46 (4.3%) | 3 | 1/7 (14.3%) | 1 |
| Sinus tachycardia | 5/46 (10.9%) | 5 | 2/7 (28.6%) | 2 |
| Ear and labyrinth disorders | ||||
| Ear and labyrinth disorders - Other, ear fluid collection | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Ear pain | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Endocrine disorders - Other, TSH elevated | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Hearing impaired | 1/46 (2.2%) | 2 | 0/7 (0%) | 0 |
| Otitis externa | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Otitis media | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Tinnitus | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Endocrine disorders | ||||
| Adrenal insufficiency | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Hyperthyroidism | 4/46 (8.7%) | 7 | 1/7 (14.3%) | 3 |
| Hypothyroidism | 33/46 (71.7%) | 70 | 2/7 (28.6%) | 6 |
| Eye disorders | ||||
| Blurred vision | 5/46 (10.9%) | 8 | 1/7 (14.3%) | 2 |
| Dry eye | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Extraocular muscle paresis | 1/46 (2.2%) | 2 | 0/7 (0%) | 0 |
| Eye disorders - Other, Retinal degeneration | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Eye pain | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Eyelid function disorder | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Scleral disorder | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Watering eyes | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal distension | 3/46 (6.5%) | 5 | 0/7 (0%) | 0 |
| Abdominal pain | 30/46 (65.2%) | 66 | 4/7 (57.1%) | 7 |
| Bloating | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Cheilitis | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Colitis | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Constipation | 13/46 (28.3%) | 33 | 3/7 (42.9%) | 4 |
| Dental caries | 2/46 (4.3%) | 2 | 1/7 (14.3%) | 1 |
| Diarrhea | 44/46 (95.7%) | 181 | 6/7 (85.7%) | 36 |
| Dry mouth | 4/46 (8.7%) | 4 | 1/7 (14.3%) | 1 |
| Dyspepsia | 6/46 (13%) | 6 | 1/7 (14.3%) | 1 |
| Dysphagia | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Edema limbs | 5/46 (10.9%) | 7 | 1/7 (14.3%) | 1 |
| Esophageal hemorrhage | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Flatulence | 4/46 (8.7%) | 4 | 2/7 (28.6%) | 2 |
| Gastrointestinal disorders - Other, Gastroenteritis | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Gastrointestinal pain | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Hemorrhoidal hemorrhage | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Mucositis oral | 29/46 (63%) | 51 | 1/7 (14.3%) | 2 |
| Nausea | 27/46 (58.7%) | 56 | 5/7 (71.4%) | 6 |
| Oral hemorrhage | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Oral pain | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Periodontal disease | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Rectal hemorrhage | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Rectal pain | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Stomach pain | 2/46 (4.3%) | 2 | 1/7 (14.3%) | 2 |
| Toothache | 2/46 (4.3%) | 3 | 2/7 (28.6%) | 2 |
| Vomiting | 23/46 (50%) | 67 | 4/7 (57.1%) | 5 |
| General disorders | ||||
| Chills | 3/46 (6.5%) | 7 | 0/7 (0%) | 0 |
| Fatigue | 33/46 (71.7%) | 49 | 5/7 (71.4%) | 16 |
| Fever | 5/46 (10.9%) | 6 | 5/7 (71.4%) | 10 |
| Flu like symptoms | 5/46 (10.9%) | 8 | 2/7 (28.6%) | 2 |
| Gait disturbance | 0/46 (0%) | 0 | 1/7 (14.3%) | 3 |
| Malaise | 1/46 (2.2%) | 2 | 0/7 (0%) | 0 |
| Pain | 1/46 (2.2%) | 1 | 2/7 (28.6%) | 2 |
| Immune system disorders | ||||
| Allergic reaction | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Infections and infestations | ||||
| Infections and infestations - Other, Cold sores | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Infections and infestations - Other, Infection in armpit | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Infections and infestations - Other, Mouth infection | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Infections and infestations - Other, Toe nail | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Lung infection | 2/46 (4.3%) | 4 | 0/7 (0%) | 0 |
| Mucosal infection | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Nail infection | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Paronychia | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Pharyngitis | 1/46 (2.2%) | 1 | 1/7 (14.3%) | 1 |
| Rhinitis infective | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Sinusitis | 3/46 (6.5%) | 6 | 2/7 (28.6%) | 3 |
| Skin infection | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Upper respiratory infection | 10/46 (21.7%) | 10 | 0/7 (0%) | 0 |
| Urinary tract infection | 11/46 (23.9%) | 13 | 0/7 (0%) | 0 |
| Vaginal infection | 3/46 (6.5%) | 3 | 0/7 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Fall | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Fracture | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Wound complication | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Investigations | ||||
| Activated partial thromboplastin time prolonged | 2/46 (4.3%) | 2 | 1/7 (14.3%) | 1 |
| Alanine aminotransferase increased | 34/46 (73.9%) | 130 | 2/7 (28.6%) | 10 |
| Alkaline phosphatase increased | 16/46 (34.8%) | 43 | 3/7 (42.9%) | 12 |
| Aspartate aminotransferase increased | 34/46 (73.9%) | 126 | 3/7 (42.9%) | 6 |
| Blood bilirubin increased | 13/46 (28.3%) | 62 | 2/7 (28.6%) | 31 |
| CPK increased | 10/46 (21.7%) | 18 | 2/7 (28.6%) | 5 |
| Creatinine increased | 7/46 (15.2%) | 17 | 2/7 (28.6%) | 2 |
| Hemoglobin increased | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Investigations - Other, Bicarbonate, serum-low | 4/46 (8.7%) | 10 | 0/7 (0%) | 0 |
| Lipase increased | 1/46 (2.2%) | 4 | 0/7 (0%) | 0 |
| Lymphocyte count decreased | 21/46 (45.7%) | 98 | 3/7 (42.9%) | 18 |
| Neutrophil count decreased | 11/46 (23.9%) | 57 | 3/7 (42.9%) | 48 |
| Platelet count decreased | 16/46 (34.8%) | 71 | 4/7 (57.1%) | 14 |
| Serum amylase increased | 1/46 (2.2%) | 8 | 1/7 (14.3%) | 3 |
| Weight gain | 2/46 (4.3%) | 3 | 0/7 (0%) | 0 |
| Weight loss | 25/46 (54.3%) | 73 | 3/7 (42.9%) | 9 |
| White blood cell decreased | 22/46 (47.8%) | 79 | 3/7 (42.9%) | 37 |
| Lymphocyte count increased | 3/46 (6.5%) | 4 | 0/7 (0%) | 0 |
| Thyroid stimulating hormone increased | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Metabolism and nutrition disorders | ||||
| Anorexia | 17/46 (37%) | 22 | 5/7 (71.4%) | 6 |
| Dehydration | 6/46 (13%) | 10 | 2/7 (28.6%) | 3 |
| Hypercalcemia | 22/46 (47.8%) | 46 | 2/7 (28.6%) | 2 |
| Hyperglycemia | 5/46 (10.9%) | 7 | 1/7 (14.3%) | 1 |
| Hyperkalemia | 11/46 (23.9%) | 16 | 1/7 (14.3%) | 3 |
| Hypermagnesemia | 13/46 (28.3%) | 15 | 0/7 (0%) | 0 |
| Hypernatremia | 3/46 (6.5%) | 4 | 3/7 (42.9%) | 3 |
| Hyperuricemia | 7/46 (15.2%) | 23 | 0/7 (0%) | 0 |
| Hypoalbuminemia | 27/46 (58.7%) | 101 | 0/7 (0%) | 0 |
| Hypocalcemia | 10/46 (21.7%) | 17 | 3/7 (42.9%) | 4 |
| Hypoglycemia | 4/46 (8.7%) | 4 | 0/7 (0%) | 0 |
| Hypokalemia | 9/46 (19.6%) | 11 | 1/7 (14.3%) | 1 |
| Hypomagnesemia | 27/46 (58.7%) | 79 | 0/7 (0%) | 0 |
| Hyponatremia | 29/46 (63%) | 71 | 1/7 (14.3%) | 2 |
| Hypophosphatemia | 8/46 (17.4%) | 28 | 1/7 (14.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 5/46 (10.9%) | 5 | 1/7 (14.3%) | 1 |
| Back pain | 14/46 (30.4%) | 17 | 4/7 (57.1%) | 5 |
| Bone pain | 4/46 (8.7%) | 5 | 0/7 (0%) | 0 |
| Chest wall pain | 4/46 (8.7%) | 4 | 1/7 (14.3%) | 4 |
| Flank pain | 1/46 (2.2%) | 1 | 1/7 (14.3%) | 1 |
| Joint range of motion decreased | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Myalgia | 4/46 (8.7%) | 6 | 2/7 (28.6%) | 3 |
| Neck pain | 3/46 (6.5%) | 5 | 0/7 (0%) | 0 |
| Non-cardiac chest pain | 6/46 (13%) | 7 | 3/7 (42.9%) | 8 |
| Pain in extremity | 7/46 (15.2%) | 12 | 5/7 (71.4%) | 8 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Tumor pain | 14/46 (30.4%) | 22 | 2/7 (28.6%) | 5 |
| Nervous system disorders | ||||
| Dizziness | 16/46 (34.8%) | 26 | 1/7 (14.3%) | 1 |
| Dysgeusia | 3/46 (6.5%) | 3 | 2/7 (28.6%) | 2 |
| Headache | 22/46 (47.8%) | 80 | 6/7 (85.7%) | 15 |
| Hypersomnia | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Nervous system disorders - Other, Right side paresthesia | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Paresthesia | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Peripheral sensory neuropathy | 6/46 (13%) | 6 | 0/7 (0%) | 0 |
| Seizure | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Sinus pain | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Somnolence | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Tremor | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Psychiatric disorders | ||||
| Anxiety | 6/46 (13%) | 10 | 1/7 (14.3%) | 1 |
| Confusion | 2/46 (4.3%) | 3 | 0/7 (0%) | 0 |
| Depression | 5/46 (10.9%) | 9 | 2/7 (28.6%) | 4 |
| Insomnia | 11/46 (23.9%) | 15 | 1/7 (14.3%) | 1 |
| Personality change | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Hematuria | 3/46 (6.5%) | 6 | 1/7 (14.3%) | 1 |
| Hemoglobinuria | 19/46 (41.3%) | 53 | 1/7 (14.3%) | 1 |
| Proteinuria | 34/46 (73.9%) | 152 | 5/7 (71.4%) | 21 |
| Renal and urinary disorders - Other, Dysuria | 1/46 (2.2%) | 1 | 1/7 (14.3%) | 1 |
| Urinary frequency | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Urinary tract pain | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Urinary urgency | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Urine discoloration | 1/46 (2.2%) | 2 | 0/7 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Breast pain | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Erectile dysfunction | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Irregular menstruation | 4/46 (8.7%) | 5 | 0/7 (0%) | 0 |
| Menorrhagia | 3/46 (6.5%) | 4 | 0/7 (0%) | 0 |
| Pelvic pain | 1/46 (2.2%) | 20 | 0/7 (0%) | 0 |
| Testicular disorder | 1/46 (2.2%) | 2 | 0/7 (0%) | 0 |
| Testicular pain | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Uterine hemorrhage | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Vaginal hemorrhage | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Vaginal pain | 0/46 (0%) | 0 | 1/7 (14.3%) | 2 |
| Gynecomastia | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Allergic rhinitis | 7/46 (15.2%) | 8 | 2/7 (28.6%) | 2 |
| Cough | 12/46 (26.1%) | 14 | 3/7 (42.9%) | 3 |
| Dyspnea | 3/46 (6.5%) | 4 | 2/7 (28.6%) | 2 |
| Epistaxis | 8/46 (17.4%) | 12 | 3/7 (42.9%) | 9 |
| Hoarseness | 4/46 (8.7%) | 4 | 0/7 (0%) | 0 |
| Hypoxia | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Laryngeal hemorrhage | 2/46 (4.3%) | 2 | 0/7 (0%) | 0 |
| Nasal congestion | 9/46 (19.6%) | 18 | 1/7 (14.3%) | 1 |
| Pericardial effusion | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Pharyngolaryngeal pain | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Postnasal drip | 3/46 (6.5%) | 3 | 0/7 (0%) | 0 |
| Productive cough | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders - Other, Running nose | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Sneezing | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Sore throat | 4/46 (8.7%) | 4 | 4/7 (57.1%) | 6 |
| Voice alteration | 11/46 (23.9%) | 12 | 1/7 (14.3%) | 1 |
| Wheezing | 1/46 (2.2%) | 2 | 0/7 (0%) | 0 |
| Rhinorrhea | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 5/46 (10.9%) | 9 | 0/7 (0%) | 0 |
| Dry skin | 4/46 (8.7%) | 5 | 1/7 (14.3%) | 1 |
| Hyperhidrosis | 6/46 (13%) | 7 | 0/7 (0%) | 0 |
| Nail loss | 4/46 (8.7%) | 4 | 0/7 (0%) | 0 |
| Palmar-plantar erythrodysesthesia syndrome | 25/46 (54.3%) | 35 | 1/7 (14.3%) | 3 |
| Photosensitivity | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Pruritus | 3/46 (6.5%) | 3 | 1/7 (14.3%) | 1 |
| Rash acneiform | 11/46 (23.9%) | 19 | 2/7 (28.6%) | 5 |
| Rash maculo-papular | 3/46 (6.5%) | 3 | 3/7 (42.9%) | 3 |
| Skin and subcutaneous tissue disorders - Other, Acne | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Skin and subcutaneous tissue disorders - Other, Fight laceration | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Skin and subcutaneous tissue disorders - Other, Perianal irritation | 0/46 (0%) | 0 | 1/7 (14.3%) | 1 |
| Skin and subcutaneous tissue disorders - Other, Skin and subcut. Tissue disorder | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Skin hyperpigmentation | 1/46 (2.2%) | 1 | 1/7 (14.3%) | 1 |
| Skin hypopigmentation | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Vascular disorders | ||||
| Hot flashes | 3/46 (6.5%) | 4 | 0/7 (0%) | 0 |
| Hypertension | 35/46 (76.1%) | 879 | 3/7 (42.9%) | 13 |
| Hypotension | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Thromboembolic event | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
| Vascular disorders - Other, Hemoptysis | 1/46 (2.2%) | 1 | 0/7 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Alice Chen |
|---|---|
| Organization | National Cancer Institute |
| Phone | 240-781-3274 |
| chenali@nih.gov |
- 090192
- 09-C-0192