Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Doxorubicin and Pembrolizumab for Sarcoma (NCT NCT03056001)
NCT ID: NCT03056001
Last Updated: 2023-11-18
Results Overview
Severe or life-threatening adverse events will be determined for each subject as a binary variable indicating whether or not the subject experienced at least one adverse event that meets the following criteria: is considered a serious adverse event (per CFR 21 Part 312), is study treatment related per the Sponsor-Investigator, and considered to be clinically significant by the Sponsor-Investigator. An adverse event will be considered study treatment related if it is determined that the event is at least possibly related to either pembrolizumab, doxorubicin, or both.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From enrollment to at least 90 days following cessation of study treatment. The median time on treatment was 5.8 months.
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Doxorubicin
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Doxorubicin
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Overall Study
Death
|
24
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of Doxorubicin and Pembrolizumab for Sarcoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Doxorubicin
n=30 Participants
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
Primary Tumor Site
Extremity - Arm
|
2 Participants
n=5 Participants
|
|
Primary Tumor Site
Extremity - Leg
|
8 Participants
n=5 Participants
|
|
Primary Tumor Site
Retroperitoneal/Abdomen
|
13 Participants
n=5 Participants
|
|
Primary Tumor Site
Other
|
7 Participants
n=5 Participants
|
|
Histology
Liposarcoma
|
7 Participants
n=5 Participants
|
|
Histology
Leiomyosarcoma
|
10 Participants
n=5 Participants
|
|
Histology
Synovial Sarcoma
|
1 Participants
n=5 Participants
|
|
Histology
Undifferentiated Pleomorphic Sarcoma
|
4 Participants
n=5 Participants
|
|
Histology
Angiosarcoma
|
2 Participants
n=5 Participants
|
|
Histology
Rhabdomyosarcoma
|
1 Participants
n=5 Participants
|
|
Histology
Epithelioid angiosarcoma
|
1 Participants
n=5 Participants
|
|
Histology
Fibromyxoid sarcoma/sclerosing epithelioid fibrosarcoma
|
1 Participants
n=5 Participants
|
|
Histology
Malignant fibrous histiocytoma
|
1 Participants
n=5 Participants
|
|
Histology
Spindle cell solitary fibrous tumor
|
1 Participants
n=5 Participants
|
|
Histology
Extraskeletal osteosarcoma
|
1 Participants
n=5 Participants
|
|
Metastatic Site
Liver
|
6 Participants
n=5 Participants
|
|
Metastatic Site
Lung
|
8 Participants
n=5 Participants
|
|
Metastatic Site
Lymph Node
|
2 Participants
n=5 Participants
|
|
Metastatic Site
Other
|
13 Participants
n=5 Participants
|
|
Metastatic Site
N/A - no metastatic disease
|
1 Participants
n=5 Participants
|
|
Prior Lines of Systemic Treatment for Sarcoma
0 prior lines
|
25 Participants
n=5 Participants
|
|
Prior Lines of Systemic Treatment for Sarcoma
1 prior line
|
2 Participants
n=5 Participants
|
|
Prior Lines of Systemic Treatment for Sarcoma
2 prior lines
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to at least 90 days following cessation of study treatment. The median time on treatment was 5.8 months.Population: The evaluable population will consist of all subjects who begin study therapy.
Severe or life-threatening adverse events will be determined for each subject as a binary variable indicating whether or not the subject experienced at least one adverse event that meets the following criteria: is considered a serious adverse event (per CFR 21 Part 312), is study treatment related per the Sponsor-Investigator, and considered to be clinically significant by the Sponsor-Investigator. An adverse event will be considered study treatment related if it is determined that the event is at least possibly related to either pembrolizumab, doxorubicin, or both.
Outcome measures
| Measure |
Pembrolizumab + Doxorubicin
n=30 Participants
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Number of Participants With at Least One Severe or Life-Threatening Adverse Event
|
1 Participants
|
SECONDARY outcome
Timeframe: From treatment start to date of death, or censored as described; assessed for approximately 5 yrs or until censoring rate for entire study reduced to 20%, whichever occurred first. When the censoring rate reached 20%, OS time ranged from 0.1 - 4.8 yrs.Population: The evaluable population consisted of all enrolled subjects who began study therapy.
OS is defined as the duration from treatment start date to the date of death from any cause. Subjects who are alive or lost to follow up at the time of the analysis will be censored at the last known date they were alive.
Outcome measures
| Measure |
Pembrolizumab + Doxorubicin
n=30 Participants
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Overall Survival (OS)
|
1.3 years
Interval 0.8 to 2.1
|
SECONDARY outcome
Timeframe: From treatment start date to date of progression/death, or censored as described; assessed for approximately 2 years.Population: The evaluable population consisted of all enrolled subjects who began study therapy.
PFS is defined as time from enrollment to time of progression or death. Disease progression (PD) may be determined objectively per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of longest diameters of target lesions, a measurable increase in non-target lesion, or appearance of new lesions) or subjectively as determined by investigator (with evidence documented in the medical records). If the subject died without documented PD, date of progression will be date of death. For surviving subjects who did not have documented PD, PFS was censored at last radiologic assessment. For subjects who received subsequent anticancer therapy prior to documented PD, PFS was censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experienced a PFS event following an interval equal to two or more scheduled radiologic assessments were censored at last assessment prior to first missed assessment.
Outcome measures
| Measure |
Pembrolizumab + Doxorubicin
n=30 Participants
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Progression-free Survival (PFS)
|
5.7 months
Interval 4.1 to 8.3
|
SECONDARY outcome
Timeframe: From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for a median of 5.8 months)Population: The evaluable population will consist of all subjects who begin study therapy and have measurable disease at baseline.
Objective response was determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 response criteria. A CR is indicated by disappearance of all target and non target lesions. A PR is indicated by \>=30% decrease in sum of longest diameter of target lesions with baseline as reference.
Outcome measures
| Measure |
Pembrolizumab + Doxorubicin
n=30 Participants
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Number of Subjects With an Objective Response
|
11 Participants
|
SECONDARY outcome
Timeframe: From date of response to date of progression/death, or censored as described above; assessed for approximately 2 years.Population: The evaluable population consisted of all enrolled subjects who begin study therapy and achieve objective response (CR or PR) on study treatment.
Duration of Response (DoR) is defined as the duration of time from the first assessment that determined a CR or PR to the date of the first occurrence of progressive disease or death. Progression events and the censoring mechanism for DoR will be the same as described for PFS. DoR will be determined for each subject using the RECIST 1.1 criteria.
Outcome measures
| Measure |
Pembrolizumab + Doxorubicin
n=11 Participants
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Duration of Response (DoR)
|
8.0 months
Interval 2.8 to 34.6
|
Adverse Events
Pembrolizumab + Doxorubicin
Serious events: 19 serious events
Other events: 30 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Pembrolizumab + Doxorubicin
n=30 participants at risk
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
5/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Ileus
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Death NOS
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Fever
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Gait disturbance
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Immune system disorders
Autoimmune disorder
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Lung infection
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Wound infection
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Vascular disorders
Hematoma
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Vascular disorders
Thromboembolic event
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
Other adverse events
| Measure |
Pembrolizumab + Doxorubicin
n=30 participants at risk
Participants will receive pembrolizumab IV infusion and doxorubicin IV injection on Day 1 of every 21 (+/- 3) days
Pembrolizumab: IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
Doxorubicin: IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
10/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Blood and lymphatic system disorders
Spleen disorder
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Cardiac disorders
Sinus bradycardia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
5/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Eye disorders
Blurred vision
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Eye disorders
Conjunctivitis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Eye disorders
Dry eye
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Eye disorders
Eye disorders - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Eye disorders
Watering eyes
|
16.7%
5/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
12/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
15/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
10/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Nausea
|
73.3%
22/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Rectal pain
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Rectal perforation
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Stomach pain
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Gastrointestinal disorders
Vomiting
|
43.3%
13/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Chills
|
20.0%
6/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Edema face
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Edema limbs
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Facial pain
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Fatigue
|
63.3%
19/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Fever
|
23.3%
7/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Flu like symptoms
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Gait disturbance
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Localized edema
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Malaise
|
16.7%
5/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
General disorders
Pain
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Immune system disorders
Autoimmune disorder
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Lung infection
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Rash pustular
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Skin infection
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Infections and infestations
Urinary tract infection
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Alkaline phosphatase increased
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Blood bilirubin increased
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Creatinine increased
|
16.7%
5/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Ejection fraction decreased
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Investigations - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Lipase increased
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Lymphocyte count decreased
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Neutrophil count decreased
|
46.7%
14/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Platelet count decreased
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Serum amylase increased
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Weight gain
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
Weight loss
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Investigations
White blood cell decreased
|
40.0%
12/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.3%
7/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
6/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
6/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
6/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
6/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
6/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.7%
8/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Nervous system disorders
Amnesia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Nervous system disorders
Dysgeusia
|
26.7%
8/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Nervous system disorders
Headache
|
16.7%
5/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Nervous system disorders
Paresthesia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Nervous system disorders
Presyncope
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Psychiatric disorders
Agitation
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Psychiatric disorders
Confusion
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Psychiatric disorders
Depression
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Psychiatric disorders
Insomnia
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Renal and urinary disorders
Proteinuria
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Renal and urinary disorders
Urinary tract pain
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Renal and urinary disorders
Urine discoloration
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
20.0%
6/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
10/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
8/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
3/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.7%
11/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
6/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Vascular disorders
Flushing
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Vascular disorders
Hematoma
|
6.7%
2/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Vascular disorders
Hypotension
|
16.7%
5/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
|
Vascular disorders
Thromboembolic event
|
13.3%
4/30 • Baseline, during treatment, and through 30 days after last dose of study treatment, an average of 7.3 months.
|
Additional Information
Chair of Biostatistics Department
Levine Cancer Institute
Phone: 9804422371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place