Trial Outcomes & Findings for Pembrolizumab TX-naive Distant Mets Melanoma and Use of (C11-AMT) PET at Baseline as Imaging Biomarker (NCT NCT03089606)

Last Updated: 2023-11-15

Results Overview

Association between intensity of C11-AMT PET at baseline, as measured by maximum standardized uptake value (SUV max) and objective response (OR) using computerized tomography images with intravenous contrast, as defined via RECIST v.1.1, at 12 weeks. Subject is considered responder if subject has CR or PR while subject is considered not-responder if they do not have CR or PR at 12 weeks. RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-11-15

Participant Flow

Participants were recruited from 5/31/2017 through 11/06/2020 at two cancer centers in North Carolina. Subjects were enrolled in the study between 06/01/2017 -11/11/2020.

A total of thirty-three participants consented to the study, but five were deemed to be ineligible and one withdrawn the consent during screening, and therefore were not enrolled on the study.

Participant milestones

Participant milestones
Measure	Single Arm This is a single arm study. All participants completed the study interventions which are pembrolizumab treatment, FDG PET, C11-AMT PET and CT scans.
Overall Study STARTED	27
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm This is a single arm study. All participants completed the study interventions which are pembrolizumab treatment, FDG PET, C11-AMT PET and CT scans.
Overall Study Progression after Cycle 1	1

Baseline Characteristics

Pembrolizumab TX-naive Distant Mets Melanoma and Use of (C11-AMT) PET at Baseline as Imaging Biomarker

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=27 Participants This is a single-arm study. All participants completed all the study interventions namely pembrolizumab treatment, FDG PET, C11-AMT PET, and CT scans.
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	11 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	1 Participants n=5 Participants
Race (NIH/OMB) White	26 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	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Participants who received study treatment and pretreatment C11-AMT PET scanning performed, and tumor response assessed according to RECIST v1.1. criteria based on the CT scan with IV contrast, 12 weeks after starting treatment. C11-AMT PET SUV max cut-off value = 5 was selected considering optimal cut-point analysis, based on whether participants remained free of recurrence while on study treatment or lived longer, demonstrated "higher" or "lower" C11-AMT SUV max.

Outcome measures

Outcome measures
Measure	Baseline C11AMT PET SUVmax<5 n=7 Participants Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is less than 5.	Baseline C11AMT PET SUVmax>5 n=19 Participants Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is bigger than 5.
Association of Baseline C11-AMT PET SUV Max Value With Objective Response Responder	6 Participants	6 Participants
Association of Baseline C11-AMT PET SUV Max Value With Objective Response Not-Responder	1 Participants	13 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: Subjects received at least one dose of the study treatment and response evaluation according to RECIST 1.1 at 12 weeks, were performed.

Objective Response Rate (ORR) is defined as the number of the subjects with a Complete Response, Partial Response, stable disease, and progressive disease according to Response Evaluation Criteria in Solid Tumors ( RECIST 1.1) at 12 weeks after starting to study treatment. RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Baseline C11AMT PET SUVmax<5 n=26 Participants Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is less than 5.	Baseline C11AMT PET SUVmax>5 Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is bigger than 5.
Objective Response Rate Progressive Disease	12 Participants	—
Objective Response Rate Complete response	7 Participants	—
Objective Response Rate Partial response	5 Participants	—
Objective Response Rate Stable Disease	2 Participants	—

SECONDARY outcome

Timeframe: 3 years

Population: The subjects received at least one dose of the study treatment and treatments response was assessed.

Progression Free Sruvival (PFS) is defined time from first day of treatment until disease progression as defined by RECIST1.1.

Outcome measures

Outcome measures
Measure	Baseline C11AMT PET SUVmax<5 n=26 Participants Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is less than 5.	Baseline C11AMT PET SUVmax>5 Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is bigger than 5.
Progression-Free Survival	7.4 months Interval 0.6 to 52.6	—

SECONDARY outcome

Timeframe: Baseline

Population: All the tumor lesions with measured/determined SUVmax values belong to subjects who underwent baseline C11 AMT PET and FDG PET images were included.

Associations of SUVmax values between baseline FDG-PET and baseline C11-AMT PET images were examined. To objectively determine tumor regions of interest on C11-AMT and 18F FDG PET, the voxel with the highest tracer concentration (e.g., SUVmax) was determined. The voxel with the highest AMT tracer concentration (e.g., SUVmax) as well as a background region in close proximity to the location of the tumor using the MIM vista PET viewing software (MIM software Inc., Cleveland, OH, version 7.0.5).

Outcome measures

Outcome measures
Measure	Baseline C11AMT PET SUVmax<5 n=61 Total number of tumor lesions analyzed Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is less than 5.	Baseline C11AMT PET SUVmax>5 n=61 Total number of tumor lesions analyzed Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is bigger than 5.
Association of Baseline FDG-PET and C11-AMT PET	8.5 units on a scale Interval 2.1 to 28.0	5.3 units on a scale Interval 3.1 to 23.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Tumor lesions from the subjects who participated in the trial had available FDG PET data before and after 12 weeks ofpembrolizumab treatment (or earlier, if progression). Fifty-two tumor lesions from 23 subjects were analyzed.

Assess metabolic changes at week 12 (or earlier, if patient progresses) following treatment with pembrolizumab using baseline and week 12 FDG PET. Each lesion is considered independently since subjects might have some lesion with SUV max value increased and another lesion with SUV max value decreased.

Outcome measures

Outcome measures
Measure	Baseline C11AMT PET SUVmax<5 n=20 Number of tumor lesions Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is less than 5.	Baseline C11AMT PET SUVmax>5 n=32 Number of tumor lesions Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is bigger than 5.
Metabolic Changes Not-Responder	18 Number of tumor lesions	2 Number of tumor lesions
Metabolic Changes Responder	1 Number of tumor lesions	30 Number of tumor lesions
Metabolic Changes Stable	1 Number of tumor lesions	0 Number of tumor lesions

SECONDARY outcome

Timeframe: Baseline

Population: Research tumor specimens that were collected from patients who enrolled into the study, had been previously imaged with C11-AMT PET and FDG PET imaging, and were available/suitable for IHC analysis for IDO expression by IHC. Of the 26 tumor specimens, only 18 had sufficient tumor for correlation analysis.

Outcome Measure Description: Associations between baseline C-methyl-L-tryptophan (C11-AMT) PET imaging and fluorodeoxyglucose (FDG) PET SUVmax values with melanoma-specific IDO expression by single colon immunohistochemistry (IHC) within the harvested tumors. We used the following single-color IHC scoring system to semiquantify the staining intensity and percentage of positive melanoma cells: 0 (no staining), 1+ (\<25% of melanoma cells with membrane or cytoplasmic stain), 2+ (25-80% of melanoma cells with the membrane of cytoplasmic stain), 3+ (\>80% of melanoma cells with membrane or cytoplasmic stain) scale was used.

Outcome measures

Outcome measures
Measure	Baseline C11AMT PET SUVmax<5 n=18 Participants Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is less than 5.	Baseline C11AMT PET SUVmax>5 n=18 Participants Baseline 11C-methyl-L-tryptophan (C11-AMT) positron emission tomography (PET) maximum standardized uptake value (SUVmax) is bigger than 5.
Baseline Positron Emission Tomography (PET) Parameters (SUVmax) Corresponding to Tumors That Were Subsequently Collected for Immunohistochemical (IHC) Analysis. Melanoma-specific Indoleamine 2,3-dioxygenase (IDO) Protein Expression in Research Biopsies IDO score 0	9.8 score on a scale Interval 2.7 to 20.0	5.9 score on a scale Interval 4.1 to 23.0
Baseline Positron Emission Tomography (PET) Parameters (SUVmax) Corresponding to Tumors That Were Subsequently Collected for Immunohistochemical (IHC) Analysis. Melanoma-specific Indoleamine 2,3-dioxygenase (IDO) Protein Expression in Research Biopsies IDO score 1	8.65 score on a scale Interval 4.3 to 19.0	7.8 score on a scale Interval 3.6 to 21.0
Baseline Positron Emission Tomography (PET) Parameters (SUVmax) Corresponding to Tumors That Were Subsequently Collected for Immunohistochemical (IHC) Analysis. Melanoma-specific Indoleamine 2,3-dioxygenase (IDO) Protein Expression in Research Biopsies IDO score 2	7.35 score on a scale Interval 5.7 to 21.8	3.7 score on a scale Interval 3.3 to 12.9
Baseline Positron Emission Tomography (PET) Parameters (SUVmax) Corresponding to Tumors That Were Subsequently Collected for Immunohistochemical (IHC) Analysis. Melanoma-specific Indoleamine 2,3-dioxygenase (IDO) Protein Expression in Research Biopsies IDO score 3	3.4 score on a scale Interval 3.4 to 3.4	3.1 score on a scale Interval 3.1 to 3.1

Adverse Events

Single Arm

Serious events: 5 serious events

Other events: 27 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=27 participants at risk This is a single arm study. All participants completed the study interventions which are pembrolizumab treatment, FDG PET, C11-AMT PET and CT scans.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Neutrophil count decreased	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Eye disorders Retinal detachment	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.

Other adverse events

Other adverse events
Measure	Single Arm n=27 participants at risk This is a single arm study. All participants completed the study interventions which are pembrolizumab treatment, FDG PET, C11-AMT PET and CT scans.
Blood and lymphatic system disorders Anemia	18.5% 5/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Cardiac disorders Cardiac disorders - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Cardiac disorders Chest pain - cardiac	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Ear and labyrinth disorders Hearing impaired	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Ear and labyrinth disorders Vertigo	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Endocrine disorders Endocrine disorders - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Endocrine disorders Hyperthyroidism	14.8% 4/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Endocrine disorders Hypothyroidism	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Eye disorders Blurred vision	11.1% 3/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Eye disorders Eye disorders - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Eye disorders Floaters	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Eye disorders Retinal detachment	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Gastrointestinal disorders Abdominal pain	11.1% 3/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Gastrointestinal disorders Constipation	18.5% 5/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Gastrointestinal disorders Diarrhea	18.5% 5/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Gastrointestinal disorders Dry mouth	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Gastrointestinal disorders Nausea	18.5% 5/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Gastrointestinal disorders Vomiting	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
General disorders Edema limbs	11.1% 3/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
General disorders Facial pain	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
General disorders Fatigue	88.9% 24/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
General disorders Flu like symptoms	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
General disorders Localized edema	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
General disorders Pain	40.7% 11/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Hepatobiliary disorders Hepatic pain	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Immune system disorders Immune system disorders - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Infections and infestations Infections and infestations - Other, specify	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Infections and infestations Papulopustular rash	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Injury, poisoning and procedural complications Seroma	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Alanine aminotransferase increased	18.5% 5/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Alkaline phosphatase increased	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Aspartate aminotransferase increased	22.2% 6/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Blood bilirubin increased	14.8% 4/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Creatinine increased	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Investigations - Other, specify	11.1% 3/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Lymphocyte count decreased	48.1% 13/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Neutrophil count decreased	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations Platelet count decreased	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Investigations White blood cell decreased	18.5% 5/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Anorexia	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Dehydration	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Hypercalcemia	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Hyperglycemia	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Hyperkalemia	14.8% 4/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Hypoalbuminemia	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Hyponatremia	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Metabolism and nutrition disorders Obesity	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	14.8% 4/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Musculoskeletal and connective tissue disorders Arthritis	11.1% 3/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Musculoskeletal and connective tissue disorders Back pain	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Musculoskeletal and connective tissue disorders Bone pain	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	14.8% 4/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Musculoskeletal and connective tissue disorders Neck pain	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Nervous system disorders Dizziness	14.8% 4/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Nervous system disorders Dysesthesia	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Nervous system disorders Dysgeusia	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Nervous system disorders Headache	22.2% 6/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Nervous system disorders Ischemia cerebrovascular	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Nervous system disorders Paresthesia	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Nervous system disorders Peripheral sensory neuropathy	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Psychiatric disorders Anxiety	14.8% 4/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Psychiatric disorders Depression	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Psychiatric disorders Insomnia	11.1% 3/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Psychiatric disorders Psychiatric disorders - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Renal and urinary disorders Chronic kidney disease	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Renal and urinary disorders Renal and urinary disorders - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Renal and urinary disorders Urinary frequency	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Respiratory, thoracic and mediastinal disorders Cough	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Respiratory, thoracic and mediastinal disorders Sinus disorder	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnea	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Skin and subcutaneous tissue disorders Dry skin	11.1% 3/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Skin and subcutaneous tissue disorders Pruritus	40.7% 11/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Skin and subcutaneous tissue disorders Rash acneiform	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.9% 7/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Skin and subcutaneous tissue disorders Scalp pain	3.7% 1/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	18.5% 5/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Skin and subcutaneous tissue disorders Skin hypopigmentation	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Surgical and medical procedures Surgical and medical procedures - Other, specify	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Vascular disorders Hot flashes	7.4% 2/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Vascular disorders Hypertension	18.5% 5/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Vascular disorders Lymphedema	11.1% 3/27 • Up to 114 days. Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.

Additional Information

Melahat G. Canter MD MS ACRP-CP, Clinical Trial Analyst

University of North Carolina Lineberger Comprehensive Cancer Center

Phone: (919) 962-0000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place