Trial Outcomes & Findings for Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection (NCT NCT03728426)

Last Updated: 2023-03-08

Results Overview

The virologic response milestones are defined as: 1) Any decrease in CMV DNA from baseline (Week 0), measured on week 3 and 2) A ≥2 log decrease in CMV DNA from baseline, or an undetectable CMV DNA, measured on week 6. For patients with clinical CMV disease, the clinical response milestones are defined as: 1) Stabilization of clinical disease by week 3 (i.e. no worsening signs or symptoms compared to week 1) as assessed by the site investigator and 2) Improvement or resolution of clinical disease by week 6 (i.e., improvement in signs and symptoms of affected organs \[resolution of diarrhea, pneumonia, hepatitis, retinitis, etc.\]) 3) Patients with clinical CMV disease should also meet virological response milestones outlined above to support the continuation of letermovir therapy. Patients who enter the study based solely on documented CMV disease by histopathology in the absence of quantifiable CMV virus load should remain nonquantifiable (less than 137 IU/mL).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6 weeks

Results posted on

2023-03-08

Participant Flow

163 individuals were screened, 10 were enrolled in the study from Dana-Farber Cancer Institute inpatient and outpatient settings.

Participant milestones

Participant milestones
Measure	Letermovir Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.
Overall Study STARTED	10
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Letermovir Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.
Overall Study Death	3

Baseline Characteristics

Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Letermovir n=10 Participants Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.
Age, Continuous	62.15 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 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	1 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	2 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	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Baseline CMV viral load	1272 IU/mL n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Letermovir n=10 Participants Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.
Virological Response on Treatment Week 6	5 Participants

SECONDARY outcome

Timeframe: 6 months

number of patients alive

Outcome measures

Outcome measures
Measure	Letermovir n=10 Participants Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.
Overall Survival	7 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 5 participants had CMV progression or death

Time from study enrollment to CMV progression or death whichever occurs first

Outcome measures

Outcome measures
Measure	Letermovir n=5 Participants Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.
CMV Progression-free Survival	13 days Interval 13.0 to 19.0

SECONDARY outcome

Timeframe: 6 months

Population: All participants

time to undetectable plasma CMV DNA

Outcome measures

Outcome measures
Measure	Letermovir n=10 Participants Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.
Kinetics of Viral Clearance	166 days Interval 147.0 to 168.0

SECONDARY outcome

Timeframe: 6 Weeks

Population: 1 participant met the definition for CMV disease

Virological response and a concomitant clinical response in patients with CMV disease by Week 6 of treatment. For patients with clinical CMV disease, the clinical response milestones are defined as: 1. Stabilization of clinical disease by week 3 (i.e. no worsening signs or symptoms compared to week 1) as assessed by the site investigator and 2. Improvement or resolution of clinical disease by week 6 (i.e., improvement in signs and symptoms of affected organs \[resolution of diarrhea, pneumonia, hepatitis, retinitis, etc.\]) 3. Patients with clinical CMV disease should also meet virological response milestones outlined above to support the continuation of letermovir therapy. Patients who enter the study based solely on documented CMV disease by histopathology in the absence of quantifiable CMV virus load should remain nonquantifiable (less than 137 IU/mL).

Outcome measures

Outcome measures
Measure	Letermovir n=1 Participants Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.
Percent of Patients With a Clinically Meaningful Treatment Response to Letermovir Treatment	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: All participants analyzed for letermovir breakthrough infections

Number of participants with breakthrough letermovir-resistant CMV infection in patients receiving letermovir treatment who experienced an initial virological response.

Outcome measures

Outcome measures
Measure	Letermovir n=10 Participants Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.
Emergence of Letermovir-resistant CMV Virus in Patients Treated in This Setting	0 Participants

Adverse Events

Letermovir

Serious events: 6 serious events

Other events: 10 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Letermovir n=10 participants at risk Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. 8 participants received the dose of 480mg/day, and 2 participants receiving cyclosporine received 240mg/day, which is the standard adjusted dose based on well-known interactions between letermovir and cyclosporine. Based on prior pharmacokinetic studies of letermovir, no adverse events related to the dose used for dose-adjustment are expected.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Infections and infestations Lung Infection	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Cardiac disorders Heart Failure	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Immune system disorders Immune system disorders - Other, specify	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Cardiac disorders Cardiac Arrest	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Nervous system disorders Encephalopathy	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.

Other adverse events

Other adverse events
Measure	Letermovir n=10 participants at risk Open label letermovir will be administered daily for up to 12 weeks. The study allows an optional additional 12 weeks of treatment for secondary prophylaxis if clinically indicated. Letermovir: Patients will receive intravenous or oral letermovir at a dose of 480mg/day. 8 participants received the dose of 480mg/day, and 2 participants receiving cyclosporine received 240mg/day, which is the standard adjusted dose based on well-known interactions between letermovir and cyclosporine. Based on prior pharmacokinetic studies of letermovir, no adverse events related to the dose used for dose-adjustment are expected.
Gastrointestinal disorders Nausea	40.0% 4/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Gastrointestinal disorders Diarrhea	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Respiratory, thoracic and mediastinal disorders Lung infection	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Hepatobiliary disorders Alanine aminotransferase increased	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Infections and infestations Bacteremia	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Blood and lymphatic system disorders Epistaxis	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Nervous system disorders Peripheral sensory neuropathy	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Respiratory, thoracic and mediastinal disorders Pneumothorax	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Vascular disorders Vascular disorders	20.0% 2/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Metabolism and nutrition disorders Acidosis	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Hepatobiliary disorders Alkaline phosphatase increased	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Hepatobiliary disorders Aspartate aminotransferase increased	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Infections and infestations Bone infection	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Blood and lymphatic system disorders Bruising	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Blood and lymphatic system disorders Disease progression of hematologic malignancy	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Ear and labyrinth disorders Ear and labyrinth disorders	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
General disorders Fatigue	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
General disorders Fever	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Gastrointestinal disorders Gastrointestinal disorders	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Nervous system disorders Headache	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Renal and urinary disorders Hematuria	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Hepatobiliary disorders Hepatobiliary disorders	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Metabolism and nutrition disorders Hyperkalemia	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Cardiac disorders Hypertension	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Infections and infestations Infections and infestations	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
General disorders Insomnia	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
General disorders Malaise	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Musculoskeletal and connective tissue disorders peripheral ischemia	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Blood and lymphatic system disorders Platelet count decreased	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Infections and infestations Skin infection	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Infections and infestations Soft tissue infection	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Respiratory, thoracic and mediastinal disorders Sore throat	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Nervous system disorders Vertigo	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Gastrointestinal disorders Vomiting	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.
Blood and lymphatic system disorders Increased monocytes	10.0% 1/10 • 6 months Definitions aligned with clinicaltrials.gov definitions. All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. Investigators must report any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form.

Additional Information

Dr. Amy Sherman

Brigham and Women's Hospital/Dana-Farber Cancer Institute

Phone: 6175253575

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place