Trial Outcomes & Findings for Expansion Trial for Axitinib In Head And Neck Cancer (NCT NCT02762513)

NCT ID: NCT02762513

Last Updated: 2021-05-05

Results Overview

Evaluable defined as any participant who receives at least one cycle of Axitinib. Number of evaluable patients and percentage of patients alive at 6 months is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: 6 Months after treatment initiation
• Results posted on: 2021-05-05

Participant Flow

1 patient enrolled but progressed before starting study treatment.

Participant milestones

Measure	Axitinib Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only patients with previous exposure to PD-1 inhibitor are included in this measure (n=11)

Baseline characteristics by cohort

Measure	Axitinib n=28 Participants Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
Age, Continuous	63.9 years n=28 Participants
Sex: Female, Male Female	3 Participants n=28 Participants
Sex: Female, Male Male	25 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=28 Participants
Race (NIH/OMB) Asian	0 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	1 Participants n=28 Participants
Race (NIH/OMB) White	27 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=28 Participants
Region of Enrollment United States	28 Participants n=28 Participants
ECOG performance status 0 (fully functional)	11 Participants n=28 Participants
ECOG performance status 1 (minor impairment)	17 Participants n=28 Participants
Disease primary site Oral cavity	2 Participants n=28 Participants
Disease primary site Oropharynx	13 Participants n=28 Participants
Disease primary site Larynx	4 Participants n=28 Participants
Disease primary site Nasopharynx	3 Participants n=28 Participants
Disease primary site Cutaneous	6 Participants n=28 Participants
HPV status Positive	10 Participants n=28 Participants
HPV status Negative	17 Participants n=28 Participants
HPV status Unknown	1 Participants n=28 Participants
Previous lines of therapy 0	11 Participants n=28 Participants
Previous lines of therapy 1	6 Participants n=28 Participants
Previous lines of therapy 2	5 Participants n=28 Participants
Previous lines of therapy >=3	6 Participants n=28 Participants
Previous exposure to platinum Sensitive	11 Participants n=28 Participants
Previous exposure to platinum Refractory	17 Participants n=28 Participants
Previous exposure to PD-1 inhibitor Primary resistant	3 Participants n=11 Participants • Only patients with previous exposure to PD-1 inhibitor are included in this measure (n=11)
Previous exposure to PD-1 inhibitor Acquired resistance	8 Participants n=11 Participants • Only patients with previous exposure to PD-1 inhibitor are included in this measure (n=11)

PRIMARY outcome

Timeframe: 6 Months after treatment initiation

Evaluable defined as any participant who receives at least one cycle of Axitinib. Number of evaluable patients and percentage of patients alive at 6 months is reported.

Outcome measures

Measure	Axitinib n=28 Participants Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
Number of Evaluable Patients Alive at 6 Months	71 percentage of participants Interval 53.0 to 85.0

SECONDARY outcome

Timeframe: Up to approximately 2.5 years

median will be calculated by Kaplan-Meier method.

Outcome measures

Measure	Axitinib n=28 Participants Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
Median Overall Survival Time	9.8 months Interval 5.9 to 12.2

SECONDARY outcome

Timeframe: Up to approximately 2.5 years

Median will be calculated by Kaplan-Meier method.

Outcome measures

Measure	Axitinib n=28 Participants Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
Median Progression Free Survival (PFS) Time	3.5 months Interval 2.4 to 5.4

SECONDARY outcome

Timeframe: 16 Weeks

Tabulation of best response measured by Choi. Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progression (PD) at 16 weeks. CR is defined as no new lesions and the disappearance of all lesions. PR is defined as a decrease in size of ≥ 10% or a decrease in tumor density (HU) ≥ 15% on CT (Computerized Tomography), no new lesions and no obvious progression of non-measurable disease

Outcome measures

Measure	Axitinib n=28 Participants Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
Best Overall Response Progressive disease	10 Participants
Best Overall Response Stable disease	3 Participants
Best Overall Response Partial response	11 Participants
Best Overall Response Complete response	1 Participants
Best Overall Response Off treatment before 8-wk scan	3 Participants

SECONDARY outcome

Timeframe: Duration of treatment and up to 28 days after treatment discontinuation

Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. For any treatment-related toxicity that occurred at any grade with a frequency greater than 10% in the overall study population, grade 3 or worse toxicities are shown here.

Outcome measures

Measure	Axitinib n=28 Participants Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
The Number of Patients That Experience Grade 3 or Worse Toxicities Fatigue	6 Participants
The Number of Patients That Experience Grade 3 or Worse Toxicities Hypertension	2 Participants
The Number of Patients That Experience Grade 3 or Worse Toxicities Oral mucositis	2 Participants
The Number of Patients That Experience Grade 3 or Worse Toxicities Diarrhea	1 Participants
The Number of Patients That Experience Grade 3 or Worse Toxicities Oral pain	1 Participants
The Number of Patients That Experience Grade 3 or Worse Toxicities Bleeding	1 Participants

Adverse Events

Axitinib

Serious events: 8 serious events

Other events: 27 other events

Deaths: 20 deaths

Serious adverse events

Measure	Axitinib n=28 participants at risk Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
Cardiac disorders Cardiac arrest	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Abdominal pain	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Diarrhea	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Hepatobiliary disorders Cholecystitis	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Infections and infestations Infections and infestations - Other	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Infections and infestations Lung infection	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Infections and infestations Sepsis	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Infections and infestations Upper respiratory infection	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Dehydration	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Hyperkalemia	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Musculoskeletal and connective tissue disorders Back pain	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Musculoskeletal and connective tissue disorders Bone pain	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Nervous system disorders Headache	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Renal and urinary disorders Acute kidney injury	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).

Other adverse events

Measure	Axitinib n=28 participants at risk Participants will receive 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities
Blood and lymphatic system disorders Anemia	7.1% 2/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Endocrine disorders Hyperparathyroidism	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Endocrine disorders Hypothyroidism	10.7% 3/28 • Number of events 4 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Eye disorders Eye disorders - Other	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Eye disorders Eye pain	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Eye disorders Papilledema	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Abdominal pain	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Constipation	17.9% 5/28 • Number of events 5 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Diarrhea	28.6% 8/28 • Number of events 10 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Dry mouth	7.1% 2/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Gastrointestinal disorders - Other	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	3.6% 1/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Mucositis oral	14.3% 4/28 • Number of events 9 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Nausea	35.7% 10/28 • Number of events 10 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Oral dysesthesia	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Oral pain	14.3% 4/28 • Number of events 4 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Rectal perforation	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Gastrointestinal disorders Vomiting	17.9% 5/28 • Number of events 5 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
General disorders Edema face	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
General disorders Fatigue	75.0% 21/28 • Number of events 46 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
General disorders Neck edema	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
General disorders Non-cardiac chest pain	10.7% 3/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
General disorders Pain	25.0% 7/28 • Number of events 7 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Infections and infestations Papulopustular rash	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Infections and infestations Upper respiratory infection	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Infections and infestations Urinary tract infection	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Injury, poisoning and procedural complications Dermatitis radiation	10.7% 3/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Injury, poisoning and procedural complications Fall	7.1% 2/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Investigations Activated partial thromboplastin time prolonged	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Investigations Alanine aminotransferase increased	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Investigations Aspartate aminotransferase increased	21.4% 6/28 • Number of events 6 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Investigations Blood bilirubin increased	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Investigations Lymphocyte count decreased	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Investigations Platelet count decreased	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Investigations Weight loss	25.0% 7/28 • Number of events 9 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Anorexia	21.4% 6/28 • Number of events 7 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Dehydration	10.7% 3/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Hypercalcemia	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Hyperglycemia	10.7% 3/28 • Number of events 6 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Hyperkalemia	10.7% 3/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Hypernatremia	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Hypoglycemia	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Hypomagnesemia	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Metabolism and nutrition disorders Hyponatremia	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Musculoskeletal and connective tissue disorders Arthralgia	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Musculoskeletal and connective tissue disorders Back pain	17.9% 5/28 • Number of events 5 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Musculoskeletal and connective tissue disorders Neck pain	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Nervous system disorders Ataxia	3.6% 1/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Nervous system disorders Brachial plexopathy	3.6% 1/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Nervous system disorders Dizziness	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Nervous system disorders Dysgeusia	17.9% 5/28 • Number of events 5 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Nervous system disorders Headache	17.9% 5/28 • Number of events 6 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Nervous system disorders Peripheral motor neuropathy	7.1% 2/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Nervous system disorders Peripheral sensory neuropathy	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Nervous system disorders Tremor	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Psychiatric disorders Agitation	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Psychiatric disorders Anxiety	7.1% 2/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Psychiatric disorders Confusion	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Psychiatric disorders Depression	10.7% 3/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Psychiatric disorders Insomnia	10.7% 3/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Renal and urinary disorders Acute kidney injury	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Renal and urinary disorders Proteinuria	7.1% 2/28 • Number of events 5 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Cough	10.7% 3/28 • Number of events 4 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 4/28 • Number of events 5 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Epistaxis	10.7% 3/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Hoarseness	25.0% 7/28 • Number of events 9 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Productive cough	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Sinus disorder	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Respiratory, thoracic and mediastinal disorders Sore throat	14.3% 4/28 • Number of events 6 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Skin and subcutaneous tissue disorders Alopecia	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Skin and subcutaneous tissue disorders Hyperhidrosis	3.6% 1/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	3.6% 1/28 • Number of events 2 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Skin and subcutaneous tissue disorders Rash acneiform	3.6% 1/28 • Number of events 1 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	7.1% 2/28 • Number of events 3 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).
Vascular disorders Hypertension	53.6% 15/28 • Number of events 27 • AEs were collected from time of initial study treatment administration through death or 28 days after treatment discontinuation. Median treatment duration was three 28-day cycles (range 1-9 cycles). All-cause mortality data was collected from time of initial study treatment administration through death or up to 36 months after treatment discontinuation. Median follow-up was 18 months (range 1-36).

Additional Information

Paul Swiecicki, M.D.

University of Michigan Rogel Cancer Center

Phone: 734-647-1017

Email: pswiecic@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place