Trial Outcomes & Findings for CLR 131 Combined With Radiation for Head and Neck Cancer (NCT NCT04105543)
NCT ID: NCT04105543
Last Updated: 2025-09-02
Results Overview
Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse Events Grading (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
up to 18 weeks
Results posted on
2025-09-02
Participant Flow
Participants were enrolled from October 2020 to February 2022 at the UW Hospital and Clinics.
Participant milestones
| Measure |
CLR 131 Dose Escalation
Enrollment will start at dose level 1 (first 4 participants). Participants will receive 2 doses of CLR 131 intravenously with the first dose on day 1 followed by the second dose on day 8.
Dose Level -1 (de-escalation dose, if toxicities warrant) = 12.5 mCi/m\^2 Dose Level 1 (beginning dose) = 15.6 mCi/m\^2 Dose Level 2 (escalation dose) = 18.75 mCi/m\^2
Dose escalation will proceed with no limiting toxicities at each level (maximum of 8 participants at each dose level). With maximum tolerated dose confirmed, an expansion phase will proceed.
CLR 131: CLR 131 is a radiopharmaceutical dosed intravenously over a period of approximately 30 minutes, dose will be based on total body surface area calculated from actual body weight and height
|
|---|---|
|
CLR Dose Level 1: 15.6mCi
STARTED
|
4
|
|
CLR Dose Level 1: 15.6mCi
Participants With Dose Limiting Toxicities
|
1
|
|
CLR Dose Level 1: 15.6mCi
COMPLETED
|
4
|
|
CLR Dose Level 1: 15.6mCi
NOT COMPLETED
|
0
|
|
Dose Held at Dose Level 1: 15.6mCi
STARTED
|
12
|
|
Dose Held at Dose Level 1: 15.6mCi
Completed Treatment
|
12
|
|
Dose Held at Dose Level 1: 15.6mCi
Primary Analysis Population
|
12
|
|
Dose Held at Dose Level 1: 15.6mCi
Overall Response Rate Analysis Population
|
11
|
|
Dose Held at Dose Level 1: 15.6mCi
Completed Baseline Salivary Measures
|
10
|
|
Dose Held at Dose Level 1: 15.6mCi
Completed 3 Months Post EBRT Salivary Measures
|
9
|
|
Dose Held at Dose Level 1: 15.6mCi
Completed 6 Months Post EBRT Salivary Measures
|
5
|
|
Dose Held at Dose Level 1: 15.6mCi
Completed 12 Months Post EBRT QoL Measures
|
0
|
|
Dose Held at Dose Level 1: 15.6mCi
Died While on Study
|
8
|
|
Dose Held at Dose Level 1: 15.6mCi
COMPLETED
|
12
|
|
Dose Held at Dose Level 1: 15.6mCi
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CLR 131 Combined With Radiation for Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
CLR 131 Dose Escalation
n=12 Participants
Enrollment will start at dose level 1 (first 4 participants). Participants will receive 2 doses of CLR 131 intravenously with the first dose on day 1 followed by the second dose on day 8.
Dose Level -1 (de-escalation dose, if toxicities warrant) = 12.5 mCi/m\^2 Dose Level 1 (beginning dose) = 15.6 mCi/m\^2 Dose Level 2 (escalation dose) = 18.75 mCi/m\^2
Dose escalation will proceed with no limiting toxicities at each level (maximum of 8 participants at each dose level). With maximum tolerated dose confirmed, an expansion phase will proceed.
CLR 131 is a radiopharmaceutical dosed intravenously over a period of approximately 30 minutes, dose will be based on total body surface area calculated from actual body weight and height
|
|---|---|
|
Age, Continuous
|
65.5 years
n=99 Participants
|
|
Age, Customized
40-49 years
|
2 Participants
n=99 Participants
|
|
Age, Customized
50-59 years
|
3 Participants
n=99 Participants
|
|
Age, Customized
60-69 years
|
2 Participants
n=99 Participants
|
|
Age, Customized
70-79 years
|
3 Participants
n=99 Participants
|
|
Age, Customized
80-89 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
|
ECOG Performance Status
ECOG 0
|
9 Participants
n=99 Participants
|
|
ECOG Performance Status
ECOG 1
|
3 Participants
n=99 Participants
|
|
Primary Tumor Site
Oropharynx
|
5 Participants
n=99 Participants
|
|
Primary Tumor Site
Nasopharynx
|
1 Participants
n=99 Participants
|
|
Primary Tumor Site
Larynx
|
1 Participants
n=99 Participants
|
|
Primary Tumor Site
Oral cavity
|
4 Participants
n=99 Participants
|
|
Primary Tumor Site
Salivary Gland
|
1 Participants
n=99 Participants
|
|
T stage
T1 and T2
|
6 Participants
n=99 Participants
|
|
T stage
T3 and T4
|
6 Participants
n=99 Participants
|
|
N stage
N0 and N1
|
6 Participants
n=99 Participants
|
|
N stage
N2 and N3
|
6 Participants
n=99 Participants
|
|
AJCC 8th ed. stage
Stage I
|
2 Participants
n=99 Participants
|
|
AJCC 8th ed. stage
Stage II
|
3 Participants
n=99 Participants
|
|
AJCC 8th ed. stage
Stage III
|
3 Participants
n=99 Participants
|
|
AJCC 8th ed. stage
Stage IVA
|
2 Participants
n=99 Participants
|
|
AJCC 8th ed. stage
Stage IVB
|
2 Participants
n=99 Participants
|
|
Initial Treatment at Diagnosis
Surgical Resection: No adjuvant treatment
|
1 Participants
n=99 Participants
|
|
Initial Treatment at Diagnosis
Surgical Resection: Adjuvant radiation
|
4 Participants
n=99 Participants
|
|
Initial Treatment at Diagnosis
Surgical Resection: Adjuvant chemoradiation
|
2 Participants
n=99 Participants
|
|
Initial Treatment at Diagnosis
Definitive Chemoradiation
|
5 Participants
n=99 Participants
|
|
Recurrence Status at Study Entry
First Recurrence
|
6 Participants
n=99 Participants
|
|
Recurrence Status at Study Entry
Multiply Recurrent
|
6 Participants
n=99 Participants
|
|
Recurrence Status at Study Entry
Metastatic Disease
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 18 weeksIncidence of adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse Events Grading (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death)
Outcome measures
| Measure |
Grade 1
n=12 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
n=12 Participants
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
n=12 Participants
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
n=12 Participants
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Incidence of Treatment Related Adverse Events
Blood and lymphatic system disorders: Anemia
|
4 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Incidence of Treatment Related Adverse Events
Blood and lymphatic system disorders: Febrile neutropenia
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Gastrointestinal disorders: Dry mouth
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Gastrointestinal disorders: Dysphagia
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Gastrointestinal disorders: Mucositis oral
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Gastrointestinal disorders: Nausea
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Gastrointestinal disorders: Salivary Duct Inflammation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
General disorders: Fatigue
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
General disorders: Fever
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
General disorders: Pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Infections and infestations: Thrush
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Injury, poisoning and procedural complications: Dermatitis Radiation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Investigations: Lymphocyte count decreased
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Incidence of Treatment Related Adverse Events
Investigations: Neutrophil count decreased
|
0 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Incidence of Treatment Related Adverse Events
Investigations: Platelet count decreased
|
1 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Incidence of Treatment Related Adverse Events
Investigations: Thyroid stimulating hormone increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Investigations: Weight loss
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Investigations: White blood cell decreased
|
0 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
|
Incidence of Treatment Related Adverse Events
Metabolism and nutrition disorders: Anorexia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Musculoskeletal and connective tissue disorders: Fibrosis deep connective tissue
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Nervous system disorders: Dysgeusia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Nervous system disorders: Headache
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Related Adverse Events
Respiratory, thoracic and mediastinal disorders: Oropharyngeal pain
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 18 weeksAdverse Events Grading (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death)
Outcome measures
| Measure |
Grade 1
n=12 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
n=12 Participants
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Summary of Adverse Events Possibly Related to Treatment
Thrombocytopenia
|
11 Participants
|
9 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Leukopenia
|
11 Participants
|
9 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Lymphopenia
|
9 Participants
|
9 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Neutropenia
|
9 Participants
|
8 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Anemia
|
11 Participants
|
5 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Fatigue
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Dry mouth
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Pain, Oral and Oropharyngeal
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Febrile neutropenia
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Mucositis oral
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Anorexia
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Dysphagia
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Adverse Events Possibly Related to Treatment
Weight loss
|
2 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 daysInvestigators will use SPECT/CT imaging scans to predict the adsorbed dose of CLR 131 to tumors with the Monte Carlo method.
Outcome measures
| Measure |
Grade 1
n=12 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
CLR 131 Tumor Uptake Via SPECT/CT Imaging
|
6.23 gray (Gy)
Interval 2.65 to 8.69
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 weeksOutcome measures
| Measure |
Grade 1
n=12 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Median Radiation Treatment Time
|
43 days
Interval 36.0 to 44.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 14 weeksOutcome measures
| Measure |
Grade 1
n=24 doses
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Number of Dose Delays
Due to Toxicity
|
0 doses
|
—
|
—
|
—
|
|
Number of Dose Delays
Due to Production Difficulties
|
1 doses
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months post completion of EBRT, up to 9 months on studyPopulation: One Participant did not undergo post treatment cross-sectional imaging and thus did not have any response data.
Complete response (CR), disappearance of all tumors; Partial response (PR), at least 30% decrease in the sum of the longest diameter of target tumors; Stable disease (SD), no increase or decrease to tumor size; Progressive disease (PD), increasing tumor size. RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.
Outcome measures
| Measure |
Grade 1
n=11 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Response Rates
Complete Response
|
7 Participants
|
—
|
—
|
—
|
|
Response Rates
Partial Response
|
1 Participants
|
—
|
—
|
—
|
|
Response Rates
Stable Disease
|
1 Participants
|
—
|
—
|
—
|
|
Response Rates
Progressive Disease
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months post completion of EBRT, up to 9 months on studyPopulation: One Participant did not undergo post treatment cross-sectional imaging and thus did not have any response data.
ORR defined as the proportion of subjects who experience either a partial response or complete response within 6 months post completion of EBRT as measured by standard of care imaging (e.g. CT, MR, PET-MR).
Outcome measures
| Measure |
Grade 1
n=11 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 months post completion of EBRT (up to 9 months on study)Population: Unable to collect data from all participants at all timepoints
Swallow function assessed by Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale before and after treatment. The DIGEST scale cross references a clinician determined 'safety' grade with an 'efficiency' grade for an overall score between 0-4 where 0 is asymptomatic and 4 is life threatening. Data collected at baseline, 3 months, and 6 months post completion of external beam radiation therapy (EBRT).
Outcome measures
| Measure |
Grade 1
n=10 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
n=10 Participants
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
n=10 Participants
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Swallow Function: DIGEST Scale
baseline
|
2 score on a scale
Standard Deviation 1.075
|
1 score on a scale
Standard Deviation 0.9428
|
3 score on a scale
Standard Deviation 1.633
|
—
|
|
Swallow Function: DIGEST Scale
3 months post EBRT
|
2 score on a scale
Standard Deviation 1.30
|
1 score on a scale
Standard Deviation 0.928
|
3 score on a scale
Standard Deviation 1.58
|
—
|
|
Swallow Function: DIGEST Scale
6 months post EBRT
|
3 score on a scale
Standard Deviation 1.3
|
2 score on a scale
Standard Deviation 1.14
|
3 score on a scale
Standard Deviation 1.34
|
—
|
SECONDARY outcome
Timeframe: Assessed at 3 months and 6 months post EBRT (6 months and 9 months post-baseline). Originally pre-specified to be assessed at 12 months post EBRT, data not collectedPopulation: Unable to collect data from all participants at all timepoints
Quality of life assessed by MD Anderson Dysphagia Inventory score (MDADI) before and after treatment. MDADI is a 36-item self-assessment with global, emotional, functional, and physical sub-scales. Total possible composite score range is 20-100 where 20 is extremely low functioning and 100 is high functioning. Data collected at baseline, 3 months, and 6 months, and 12 months post EBRT.
Outcome measures
| Measure |
Grade 1
n=10 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Quality of Life: MDADI Score
baseline
|
71.6 score on a scale
Standard Deviation 15.9
|
—
|
—
|
—
|
|
Quality of Life: MDADI Score
3 months post EBRT
|
62.1 score on a scale
Standard Deviation 20.6
|
—
|
—
|
—
|
|
Quality of Life: MDADI Score
6 months post EBRT
|
55.8 score on a scale
Standard Deviation 7.68
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 months post completion of EBRT (up to 9 months on study)Population: Unable to collect data from all participants at all timepoints
Stimulated Salivary Flow before and after treatment (mL/min). Data collected at baseline, 3 months, and 6 months post EBRT.
Outcome measures
| Measure |
Grade 1
n=9 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Stimulated Salivary Flow
baseline
|
0.24 ml/min
Standard Deviation 0.26
|
—
|
—
|
—
|
|
Stimulated Salivary Flow
3 months post EBRT
|
0.18 ml/min
Standard Deviation 0.10
|
—
|
—
|
—
|
|
Stimulated Salivary Flow
6 months post EBRT
|
0.21 ml/min
Standard Deviation 0.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 months post completion of EBRT (up to 9 months on study)Population: Unable to collect data from all participants at all timepoints
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item instrument measures quality of life in cancer patients. It is scored from 0-100 where higher scores indicate higher level of response in function, symptomatology, or global health.
Outcome measures
| Measure |
Grade 1
n=10 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
n=10 Participants
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
n=10 Participants
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
EORTC QLQ-C30 Scores
baseline
|
76.7 score on a scale
Standard Deviation 16.7
|
23.08 score on a scale
Standard Deviation 17.92
|
50 score on a scale
Standard Deviation 13.82
|
—
|
|
EORTC QLQ-C30 Scores
3 months post EBRT
|
72.2 score on a scale
Standard Deviation 13.1
|
26.92 score on a scale
Standard Deviation 12.28
|
54.2 score on a scale
Standard Deviation 19.32
|
—
|
|
EORTC QLQ-C30 Scores
6 months post EBRT
|
71.1 score on a scale
Standard Deviation 11.2
|
28.21 score on a scale
Standard Deviation 19.39
|
58.3 score on a scale
Standard Deviation 15.59
|
—
|
SECONDARY outcome
Timeframe: up to 6 months post completion of EBRT (up to 9 months on study)Population: Unable to collect data from all participants at all timepoints
The XeQoLS questionnaire measures the effects of xerostomia on oral health-related quality of life. The questionnaire consists of 15 items, each rated on a 0-to-4 point Likert scale, for a total possible range of scores from 0 to 60, with higher scores indicating more severe symptom burden.
Outcome measures
| Measure |
Grade 1
n=10 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Xerostomia Quality-of-Life Scale (XeQoLS) Scores
baseline
|
15 score on a scale
Standard Deviation 14.4
|
—
|
—
|
—
|
|
Xerostomia Quality-of-Life Scale (XeQoLS) Scores
3 months post EBRT
|
16.5 score on a scale
Standard Deviation 16.9
|
—
|
—
|
—
|
|
Xerostomia Quality-of-Life Scale (XeQoLS) Scores
6 months post EBRT
|
18 score on a scale
Standard Deviation 13.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 months post completion of EBRT (up to 9 months on study)Population: Unable to collect data from all participants at all timepoints
The Xerostomia Inventory is an 11-item survey scored on a 5 point-likert scale (never, hardly ever, occasionally, fairly often, very much). Total possible range of scores is from 11-55, with higher scores indicating increased mouth dryness.
Outcome measures
| Measure |
Grade 1
n=10 Participants
Grade 1 Treatment (CLR 131) Related Adverse Events
|
Grade 2
Grade 2 Treatment (CLR 131) Related Adverse Events
|
Grade 3
Grade 3 Treatment (CLR 131) Related Adverse Events
|
Grade 4
Grade 4 Treatment (CLR 131) Related Adverse Events
|
|---|---|---|---|---|
|
Xerostomia Inventory Score
baseline
|
34.5 score on a scale
Standard Deviation 9.38
|
—
|
—
|
—
|
|
Xerostomia Inventory Score
3 months post EBRT
|
34.5 score on a scale
Standard Deviation 10.75
|
—
|
—
|
—
|
|
Xerostomia Inventory Score
6 months post EBRT
|
36.0 score on a scale
Standard Deviation 8.08
|
—
|
—
|
—
|
Adverse Events
CLR 131 Dose Escalation
Serious events: 4 serious events
Other events: 12 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
CLR 131 Dose Escalation
n=12 participants at risk
Enrollment will start at dose level 1 (first 4 participants). Participants will receive 2 doses of CLR 131 intravenously with the first dose on day 1 followed by the second dose on day 8.
Dose Level -1 (de-escalation dose, if toxicities warrant) = 12.5 mCi/m\^2 Dose Level 1 (beginning dose) = 15.6 mCi/m\^2 Dose Level 2 (escalation dose) = 18.75 mCi/m\^2
Dose escalation will proceed with no limiting toxicities at each level (maximum of 8 participants at each dose level). With maximum tolerated dose confirmed, an expansion phase will proceed.
CLR 131: CLR 131 is a radiopharmaceutical dosed intravenously over a period of approximately 30 minutes, dose will be based on total body surface area calculated from actual body weight and height
|
|---|---|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
2/12 • Number of events 2 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Infections and infestations
Laryngitis
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
Other adverse events
| Measure |
CLR 131 Dose Escalation
n=12 participants at risk
Enrollment will start at dose level 1 (first 4 participants). Participants will receive 2 doses of CLR 131 intravenously with the first dose on day 1 followed by the second dose on day 8.
Dose Level -1 (de-escalation dose, if toxicities warrant) = 12.5 mCi/m\^2 Dose Level 1 (beginning dose) = 15.6 mCi/m\^2 Dose Level 2 (escalation dose) = 18.75 mCi/m\^2
Dose escalation will proceed with no limiting toxicities at each level (maximum of 8 participants at each dose level). With maximum tolerated dose confirmed, an expansion phase will proceed.
CLR 131: CLR 131 is a radiopharmaceutical dosed intravenously over a period of approximately 30 minutes, dose will be based on total body surface area calculated from actual body weight and height
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
10/12 • Number of events 10 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Eye disorders
Watering eyes
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Gastrointestinal disorders
Dry mouth
|
41.7%
5/12 • Number of events 5 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
4/12 • Number of events 4 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
6/12 • Number of events 6 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 3 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
General disorders
Fatigue
|
66.7%
8/12 • Number of events 8 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
General disorders
Neck edema
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
General disorders
Pain
|
16.7%
2/12 • Number of events 2 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Infections and infestations
Mucosal infection
|
16.7%
2/12 • Number of events 2 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Infections and infestations
Thrush
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
50.0%
6/12 • Number of events 6 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Investigations
Lymphocyte count decreased
|
83.3%
10/12 • Number of events 10 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Investigations
Neutrophil count decreased
|
83.3%
10/12 • Number of events 10 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Investigations
Platelet count decreased
|
75.0%
9/12 • Number of events 9 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Investigations
Thyroid stimulating hormone increased
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Investigations
Weight loss
|
33.3%
4/12 • Number of events 4 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Investigations
White blood cell decreased
|
91.7%
11/12 • Number of events 11 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
5/12 • Number of events 5 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Nervous system disorders
Dysarthria
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • Number of events 2 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Nervous system disorders
Headache
|
33.3%
4/12 • Number of events 4 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Nervous system disorders
Neuralgia
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Nervous system disorders
Paresthesia
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Respiratory, thoracic and mediastinal disorders
Oral Pharyngeal pain
|
25.0%
3/12 • Number of events 3 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Vascular disorders
Hypotension
|
25.0%
3/12 • Number of events 3 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Vascular disorders
Lymphedema
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
|
Vascular disorders
Superficial thrombophlebitis
|
8.3%
1/12 • Number of events 1 • up to 85 days
SAEs through 85 days post first treatment of CLR131 reported regardless of attribution. After day 85, SAE's that had an attribution of at least possibly would be collected and reported. AEs will be recorded from time of informed consent until 28 days after last EBRT treatment or 85 days after first treatment dose of CLR 131, whichever is later. AEs will be recorded whether they are considered related to the study drug(s). Xerostomia Inventory Score was not an instrument to collect AE data
|
Additional Information
Justine Bruce, MD
University of Wisconsin Carbone Cancer Center
Phone: (608) 262-4961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place