Trial Outcomes & Findings for Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy (NCT NCT03655444)
NCT ID: NCT03655444
Last Updated: 2020-12-03
Results Overview
-The RP2D of abemaciclib is defined as the highest dose level at which fewer than 2 patients of a cohort of three patients experience a dose-limiting toxicity (DLT) during the first cycle.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Completion of enrollment to Phase I portion of study (estimated to be 3 months)
Results posted on
2020-12-03
Participant Flow
Participant milestones
| Measure |
Phase I: Abemaciclib + Nivolumab
* Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle
* Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle.
|
Phase II: Abemaciclib + Nivolumab
* Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.
* Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy
Baseline characteristics by cohort
| Measure |
Phase I: Abemaciclib + Nivolumab
n=3 Participants
* Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle
* Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle.
|
Phase II: Abemaciclib + Nivolumab
n=3 Participants
* Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.
* Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
62 years
n=4 Participants
|
62 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Completion of enrollment to Phase I portion of study (estimated to be 3 months)Population: Only phase I participants were evaluable for this outcome measure.
-The RP2D of abemaciclib is defined as the highest dose level at which fewer than 2 patients of a cohort of three patients experience a dose-limiting toxicity (DLT) during the first cycle.
Outcome measures
| Measure |
Phase I: Abemaciclib + Nivolumab
n=3 Participants
* Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle
* Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle.
|
Phase II: Abemaciclib + Nivolumab
* Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.
* Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle.
|
|---|---|---|
|
Phase I Only: Determine the Recommended Phase 2 Dose of Abemaciclib Combined With a Fixed Dose of Nivolumab
|
150 mg twice per day
|
—
|
PRIMARY outcome
Timeframe: Until death (estimated average of 13 months)* OS is defined as the time from the date of treatment to the date of death, censored at the last follow-up otherwise. * The mean survival time and standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Outcome measures
| Measure |
Phase I: Abemaciclib + Nivolumab
n=6 Participants
* Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle
* Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle.
|
Phase II: Abemaciclib + Nivolumab
* Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.
* Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle.
|
|---|---|---|
|
Overall Survival (OS) Rate
|
3.689 months
Standard Error 0.7281
|
—
|
SECONDARY outcome
Timeframe: Through completion of treatment (estimated to be 5 months)Population: -Phase II patients are the only patients evaluable.
* Complete response: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, Disappearance of all non-target lesions and normalization of tumor marker level. * Partial response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Outcome measures
| Measure |
Phase I: Abemaciclib + Nivolumab
* Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle
* Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle.
|
Phase II: Abemaciclib + Nivolumab
n=3 Participants
* Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.
* Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle.
|
|---|---|---|
|
Phase II Only: Best Overall Tumor Response
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Through completion of treatment (estimated to be 5 months)Population: Data was not collected for this outcome measure.
-The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through completion of treatment (estimated to be 5 months)-PFS is defined as the time from treatment to the date of progression or death, whichever occurs first. The alive patients without progression is censored at the last follow-up.
Outcome measures
| Measure |
Phase I: Abemaciclib + Nivolumab
n=6 Participants
* Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle
* Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle.
|
Phase II: Abemaciclib + Nivolumab
* Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.
* Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
2.82258 months
Standard Error 0.64434
|
—
|
SECONDARY outcome
Timeframe: Through 30 days after completion of treatment (estimated to be 6 months)-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Phase I: Abemaciclib + Nivolumab
n=6 Participants
* Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle
* Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle.
|
Phase II: Abemaciclib + Nivolumab
* Phase II Lead-in: Patients will be treated with abemaciclib monotherapy at the recommended phase II dose on Day -7 through Day -1 prior to starting Cycle 1 with the combination of abemaciclib and nivolumab. Patients will proceed directly from Day -1 to Cycle 1 Day 1 of combination abemaciclib + nivolumab, there is not a Day 0.
* Patients will be treated with abemaciclib at the RP2D (Days 1 through 28) + nivolumab (480 mg, Day 1) of each 4-week cycle.
|
|---|---|---|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hyperthyroidism
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hypothyroidism
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Constipation
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Cough
|
4 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Nasal congestion
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Anemia
|
5 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Diarrhea
|
3 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Dry mouth
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Dysphagia
|
3 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Mucositis oral
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Nausea
|
4 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Vomiting
|
3 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Chills
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Edema face
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Fatigue
|
5 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Non-cardiac chest pain
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Lung infection
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Thrush
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Vaginal infection
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Alanine aminotransferase increased
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Alkaline phosphatase increased
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Aspartate aminotransferase increased
|
3 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Blood bilirubin increased
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Cholesterol high
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Creatinine increased
|
6 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Blood bicarbonate decreased
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Lymphocyte count decreased
|
6 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Neutrophil count decreased
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Platelet count decreased
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Weight loss
|
4 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
White blood cell decreased
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Anorexia
|
3 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Dehydration
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hypercalcemia
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hyperglycemia
|
4 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hyperkalemia
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hypoalbuminemia
|
3 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hypocalcemia
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hypoglycemia
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hypokalemia
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hypomagnesemia
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hyponatremia
|
3 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Generalized muscle weakness
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Arthritis
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Chest wall pain
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Dizziness
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Dysarthria
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Headache
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Confusion
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Depression
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Acute kidney injury
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hematuria
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Aspiration
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Respiratory failure
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Sore throat
|
1 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Pruritus
|
2 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Hypertension
|
3 Participants
|
—
|
|
Adverse Events (AEs) Associated With the Combination of Abemaciclib and Nivolumab.
Thromboembolic event
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Compare before and after one week of abemaciclib monotherapyPopulation: The data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Phase I and Phase II: Abemaciclib + Nivolumab
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase I and Phase II: Abemaciclib + Nivolumab
n=6 participants at risk
* Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle
* Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle.
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Infections and infestations
Lung infection
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
General disorders
Non cardiac chest pain
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
Other adverse events
| Measure |
Phase I and Phase II: Abemaciclib + Nivolumab
n=6 participants at risk
* Abemaciclib (150 mg) will be administered orally twice per day (with or without food) on Days 1 through 28 of every 4-week cycle
* Nivolumab 480 mg will be given intravenously (IV) over 30 minutes on Day 1 of every 4-week cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
5/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
General disorders
Chills
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
General disorders
Edema face
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
General disorders
Fatigue
|
83.3%
5/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Infections and infestations
Thrush
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Infections and infestations
Vaginal infection
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Cholesterol high
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Creatinine increased
|
100.0%
6/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Blood bicarbonate decreased
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Lymphocyte count decreased
|
100.0%
6/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Weight loss
|
66.7%
4/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Investigations
Hypercalcemia
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
4/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
3/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
3/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Metabolism and nutrition disorders
Generalized muscle weakness
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Nervous system disorders
Dysarthria
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
4/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Vascular disorders
Hypertension
|
50.0%
3/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Adverse events were collected from start of treatment until 28 days after completion of treatment (median follow-up was 2.8 months)
|
Additional Information
Douglas R. Adkins, M.D.
Washington University School of Medicine
Phone: 314-747-8475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place