Trial Outcomes & Findings for LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer (NCT NCT04032080)
NCT ID: NCT04032080
Last Updated: 2023-09-11
Results Overview
To assess the objective response rate associated with LY3023414 and prexasertib in metastatic TNBC patients. Objective response is measured as prolonged clinical benefit; clinical benefit is defined as progression free survival on study therapy for at least 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Through study completion, approximately 2 years and 8 months
Results posted on
2023-09-11
Participant Flow
Participant milestones
| Measure |
LY3023414 + Prexasertib
Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression. Patients whose disease does not respond to the combination of LY3023414 and prexasertib may be treated with standard of care breast cancer therapies off study, at the recommendation of the treating physician.
Drug 1: LY3023414; Drug 2: Prexasertib Patients will be treated with 150 mg LY3023414 PO BID and prexasertib 80 mg/m\^2 IV administered every 2 weeks until disease progression or unacceptable toxicity. Treatment will be discontinued in patients who achieve a confirmed clinical complete response, and these patients will be followed to document the durability of the complete responses.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
LY3023414 + Prexasertib
Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression. Patients whose disease does not respond to the combination of LY3023414 and prexasertib may be treated with standard of care breast cancer therapies off study, at the recommendation of the treating physician.
Drug 1: LY3023414; Drug 2: Prexasertib Patients will be treated with 150 mg LY3023414 PO BID and prexasertib 80 mg/m\^2 IV administered every 2 weeks until disease progression or unacceptable toxicity. Treatment will be discontinued in patients who achieve a confirmed clinical complete response, and these patients will be followed to document the durability of the complete responses.
|
|---|---|
|
Overall Study
Death
|
6
|
Baseline Characteristics
LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer
Baseline characteristics by cohort
| Measure |
LY3023414 + Prexasertib
n=10 Participants
Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression. Patients whose disease does not respond to the combination of LY3023414 and prexasertib may be treated with standard of care breast cancer therapies off study, at the recommendation of the treating physician.
Drug 1: LY3023414; Drug 2: Prexasertib Patients will be treated with 150 mg LY3023414 PO BID and prexasertib 80 mg/m\^2 IV administered every 2 weeks until disease progression or unacceptable toxicity. Treatment will be discontinued in patients who achieve a confirmed clinical complete response, and these patients will be followed to document the durability of the complete responses.
|
|---|---|
|
Age, Continuous
|
57.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Primary Tumor Size
|
14.5 mm
STANDARD_DEVIATION 4.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 2 years and 8 monthsPopulation: All participants who received at least one dose of treatment.
To assess the objective response rate associated with LY3023414 and prexasertib in metastatic TNBC patients. Objective response is measured as prolonged clinical benefit; clinical benefit is defined as progression free survival on study therapy for at least 6 months.
Outcome measures
| Measure |
LY3023414 + Prexasertib
n=10 Participants
Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression. Patients whose disease does not respond to the combination of LY3023414 and prexasertib may be treated with standard of care breast cancer therapies off study, at the recommendation of the treating physician.
Drug 1: LY3023414; Drug 2: Prexasertib Patients will be treated with 150 mg LY3023414 PO BID and prexasertib 80 mg/m\^2 IV administered every 2 weeks until disease progression or unacceptable toxicity. Treatment will be discontinued in patients who achieve a confirmed clinical complete response, and these patients will be followed to document the durability of the complete responses.
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|---|---|
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Efficacy (Objective Response Rate)
|
3 Participants
|
SECONDARY outcome
Timeframe: From the time that 6 months of progression free survival on study therapy was first met until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.Population: All participants who received at least one dose of treatment.
To assess duration of response to combination of LY3023414 and prexasertib in metastatic TNBC patients. Duration of response is measured as prolonged clinical benefit; clinical benefit is defined as progression free survival on study therapy for at least 6 months.
Outcome measures
| Measure |
LY3023414 + Prexasertib
n=10 Participants
Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression. Patients whose disease does not respond to the combination of LY3023414 and prexasertib may be treated with standard of care breast cancer therapies off study, at the recommendation of the treating physician.
Drug 1: LY3023414; Drug 2: Prexasertib Patients will be treated with 150 mg LY3023414 PO BID and prexasertib 80 mg/m\^2 IV administered every 2 weeks until disease progression or unacceptable toxicity. Treatment will be discontinued in patients who achieve a confirmed clinical complete response, and these patients will be followed to document the durability of the complete responses.
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|---|---|
|
Efficacy (Duration of Response)
|
9 weeks
Interval 1.0 to 45.0
|
Adverse Events
LY3023414 + Prexasertib
Serious events: 3 serious events
Other events: 10 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
LY3023414 + Prexasertib
n=10 participants at risk
Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression. Patients whose disease does not respond to the combination of LY3023414 and prexasertib may be treated with standard of care breast cancer therapies off study, at the recommendation of the treating physician.
Drug 1: LY3023414; Drug 2: Prexasertib Patients will be treated with 150 mg LY3023414 PO BID and prexasertib 80 mg/m\^2 IV administered every 2 weeks until disease progression or unacceptable toxicity. Treatment will be discontinued in patients who achieve a confirmed clinical complete response, and these patients will be followed to document the durability of the complete responses.
|
|---|---|
|
Investigations
Neutrophil count decrease
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
Other adverse events
| Measure |
LY3023414 + Prexasertib
n=10 participants at risk
Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression. Patients whose disease does not respond to the combination of LY3023414 and prexasertib may be treated with standard of care breast cancer therapies off study, at the recommendation of the treating physician.
Drug 1: LY3023414; Drug 2: Prexasertib Patients will be treated with 150 mg LY3023414 PO BID and prexasertib 80 mg/m\^2 IV administered every 2 weeks until disease progression or unacceptable toxicity. Treatment will be discontinued in patients who achieve a confirmed clinical complete response, and these patients will be followed to document the durability of the complete responses.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain
|
20.0%
2/10 • Number of events 2 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Investigations
Abnormal HBA1C
|
20.0%
2/10 • Number of events 2 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Cardiac disorders
Abnormal LVEF
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Infections and infestations
Axillary Cellulitis
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Axillary Pain
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Blood and lymphatic system disorders
Axillary Swelling
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
30.0%
3/10 • Number of events 3 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
General disorders
Chest Pressure
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
General disorders
Chills
|
20.0%
2/10 • Number of events 3 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Cognitive Changes
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
5/10 • Number of events 5 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
20.0%
2/10 • Number of events 2 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
7/10 • Number of events 15 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
General disorders
Dry Mouth
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Dysphagia
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Renal and urinary disorders
Dysuria
|
20.0%
2/10 • Number of events 3 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Encephalopathy
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
General disorders
Fatigue
|
80.0%
8/10 • Number of events 8 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
General disorders
Fever
|
20.0%
2/10 • Number of events 3 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease (GERD)
|
30.0%
3/10 • Number of events 3 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Headache
|
60.0%
6/10 • Number of events 8 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Investigations
Hypokalemia
|
10.0%
1/10 • Number of events 2 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Infections and infestations
Influenza
|
20.0%
2/10 • Number of events 2 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Number of events 2 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain - Upper Limb
|
20.0%
2/10 • Number of events 3 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramping
|
20.0%
2/10 • Number of events 2 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
6/10 • Number of events 6 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Eye disorders
Macular Edema
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
20.0%
2/10 • Number of events 2 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
10/10 • Number of events 11 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Investigations
Neutrophil Count Decreased
|
40.0%
4/10 • Number of events 6 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Metabolism and nutrition disorders
Polydipsia
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Renal and urinary disorders
Polyuria
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Skin and subcutaneous tissue disorders
Chest Wall Redness
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
General disorders
Localized Edema
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Paresthesia
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
10.0%
1/10 • Number of events 2 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right Clavicular Mass
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Gastrointestinal disorders
Oral Pain
|
60.0%
6/10 • Number of events 6 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
General disorders
Edema Limbs
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Investigations
Platelet Count Decreased
|
60.0%
6/10 • Number of events 12 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Investigations
Thrombocytosis
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Tremor
|
20.0%
2/10 • Number of events 3 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Infections and infestations
Urinary Tract Infection
|
30.0%
3/10 • Number of events 3 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Nervous system disorders
Edema Cerebral
|
10.0%
1/10 • Number of events 1 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Eye disorders
Visual Disturbances
|
30.0%
3/10 • Number of events 3 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Gastrointestinal disorders
Vomiting
|
70.0%
7/10 • Number of events 9 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Investigations
Weight Loss
|
40.0%
4/10 • Number of events 4 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Number of events 4 • For up to 30 days following last treatment dose, approximately 7 months
All AEs are assessed and recorded during treatment and for up to 30 days following the last dose of study treatment, approximately 7 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place