Trial Outcomes & Findings for Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma (NCT NCT02325401)
NCT ID: NCT02325401
Last Updated: 2020-06-11
Results Overview
Cohorts of patients received escalating doses of metformin (2000 mg, 2550 mg, or 3000 mg divided into daily doses) with a 7-day to 14-day lead-in prior to CRT based on the modified toxicity probability interval design to allow for possible re-escalation after previous de-escalation and to maximize the ability to identify the maximum tolerated dose (MTD). Patients continued to receive metformin for the duration of CRT as tolerated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
24 months
Results posted on
2020-06-11
Participant Flow
Patients were 18 years or old, with newly diagnosis LAHNSCC and ECOG rating of better than or equal to 1, with adequate organ function. Individuals were excluded if they had a diagnosis of: nasopharyngeal cancer, metastatic disease, diabetes requiring insulin, or receipt of metformin with in the last 4 weeks, or history of intercurrent illness.
Participant milestones
| Measure |
Metformin (2000mg) With Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. This is the 2000mg cohort.
|
Metformin (2550mg) With Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. This is the 2550mg cohort.
|
Metformin (3000mg) With Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. This is the 3000mg cohort.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
5
|
|
Overall Study
COMPLETED
|
6
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Metformin (2000mg) With Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. This is the 2000mg cohort.
|
Metformin (2550mg) With Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. This is the 2550mg cohort.
|
Metformin (3000mg) With Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating. This is the 3000mg cohort.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
Baseline characteristics by cohort
| Measure |
Metformin With Chemoradiation
n=18 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
|---|---|
|
Age, Continuous
Metformin (2000mg) With Chemoradiation
|
54 Years
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Age, Continuous
Metformin (2550mg) With Chemoradiation
|
55.5 Years
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Age, Continuous
Metformin (3000mg) With Chemoradiation
|
53 Years
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Sex: Female, Male
Metformin (2000mg) With Chemoradiation · Female
|
1 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Sex: Female, Male
Metformin (2000mg) With Chemoradiation · Male
|
5 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Sex: Female, Male
Metformin (2550mg) With Chemoradiation · Female
|
0 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Sex: Female, Male
Metformin (2550mg) With Chemoradiation · Male
|
8 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Sex: Female, Male
Metformin (3000mg) With Chemoradiation · Female
|
2 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Sex: Female, Male
Metformin (3000mg) With Chemoradiation · Male
|
2 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Ethnicity (NIH/OMB)
Metformin (2000mg) With Chemoradiation · Hispanic or Latino
|
2 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Ethnicity (NIH/OMB)
Metformin (2000mg) With Chemoradiation · Not Hispanic or Latino
|
4 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Ethnicity (NIH/OMB)
Metformin (2000mg) With Chemoradiation · Unknown or Not Reported
|
0 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Ethnicity (NIH/OMB)
Metformin (2550mg) With Chemoradiation · Hispanic or Latino
|
8 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Ethnicity (NIH/OMB)
Metformin (2550mg) With Chemoradiation · Not Hispanic or Latino
|
0 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Ethnicity (NIH/OMB)
Metformin (2550mg) With Chemoradiation · Unknown or Not Reported
|
0 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Ethnicity (NIH/OMB)
Metformin (3000mg) With Chemoradiation · Hispanic or Latino
|
0 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Ethnicity (NIH/OMB)
Metformin (3000mg) With Chemoradiation · Not Hispanic or Latino
|
4 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Ethnicity (NIH/OMB)
Metformin (3000mg) With Chemoradiation · Unknown or Not Reported
|
0 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2000mg) With Chemoradiation · American Indian or Alaska Native
|
0 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2000mg) With Chemoradiation · Asian
|
0 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2000mg) With Chemoradiation · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2000mg) With Chemoradiation · Black or African American
|
0 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2000mg) With Chemoradiation · White
|
6 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2000mg) With Chemoradiation · More than one race
|
0 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2000mg) With Chemoradiation · Unknown or Not Reported
|
0 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2550mg) With Chemoradiation · American Indian or Alaska Native
|
0 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2550mg) With Chemoradiation · Asian
|
0 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2550mg) With Chemoradiation · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2550mg) With Chemoradiation · Black or African American
|
0 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2550mg) With Chemoradiation · White
|
8 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2550mg) With Chemoradiation · More than one race
|
0 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (2550mg) With Chemoradiation · Unknown or Not Reported
|
0 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (3000mg) With Chemoradiation · American Indian or Alaska Native
|
0 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (3000mg) With Chemoradiation · Asian
|
0 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (3000mg) With Chemoradiation · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (3000mg) With Chemoradiation · Black or African American
|
2 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (3000mg) With Chemoradiation · White
|
2 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (3000mg) With Chemoradiation · More than one race
|
0 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Race (NIH/OMB)
Metformin (3000mg) With Chemoradiation · Unknown or Not Reported
|
0 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
|
Tobacco Users
Metformin (2000mg) With Chemoradiation
|
3 Participants
n=6 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Tobacco Users
Metformin (2550mg) With Chemoradiation
|
7 Participants
n=8 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
|
Tobacco Users
Metformin (3000mg) With Chemoradiation
|
2 Participants
n=4 Participants • There is a total of 18 participants in three cohorts: Metformin (2000mg) (n = 6); Metformin (2500mg) (n = 8); Metformin (3000mg) (n = 4).
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Proportion of the study sample that were evaulable.
Cohorts of patients received escalating doses of metformin (2000 mg, 2550 mg, or 3000 mg divided into daily doses) with a 7-day to 14-day lead-in prior to CRT based on the modified toxicity probability interval design to allow for possible re-escalation after previous de-escalation and to maximize the ability to identify the maximum tolerated dose (MTD). Patients continued to receive metformin for the duration of CRT as tolerated.
Outcome measures
| Measure |
Metformin (2000mg) With Chemoradiation
n=6 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (2550mg) With Chemoradiation
n=8 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (3000mg) With Chemoradiation
n=4 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Metformin in Combination With Concurrent Cisplatin and Radiation
|
NA mg
The MTD for metformin could not be established reliably from the current study.
|
NA mg
The MTD for metformin could not be established reliably from the current study.
|
NA mg
The MTD for metformin could not be established reliably from the current study.
|
SECONDARY outcome
Timeframe: 36 monthsPatients were evaulated at 36 months to determine if there was recurrence of disease.
Outcome measures
| Measure |
Metformin (2000mg) With Chemoradiation
n=6 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (2550mg) With Chemoradiation
n=8 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (3000mg) With Chemoradiation
n=4 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
|---|---|---|---|
|
Number of Participants Experiencing No-Reoccurrence at 36 Months
|
6 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 36 monthsAdverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.Any participants with any adverse event at any grade was included. Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
Outcome measures
| Measure |
Metformin (2000mg) With Chemoradiation
n=6 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (2550mg) With Chemoradiation
n=8 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (3000mg) With Chemoradiation
n=4 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
6 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 months2-year progression free survival
Outcome measures
| Measure |
Metformin (2000mg) With Chemoradiation
n=6 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (2550mg) With Chemoradiation
n=8 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (3000mg) With Chemoradiation
n=4 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
|---|---|---|---|
|
Progression Free Survival
|
6 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 months2 year overall survival
Outcome measures
| Measure |
Metformin (2000mg) With Chemoradiation
n=6 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (2550mg) With Chemoradiation
n=8 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin (3000mg) With Chemoradiation
n=4 Participants
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
|---|---|---|---|
|
Overall Survival
|
5 participants
|
8 participants
|
4 participants
|
Adverse Events
Metformin With Chemoradiation- 2000mg Cohort
Serious events: 6 serious events
Other events: 6 other events
Deaths: 1 deaths
Metformin With Chemoradiation- 2550mg Cohort
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Metformin With Chemoradiation- 3000mg Cohort
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metformin With Chemoradiation- 2000mg Cohort
n=6 participants at risk
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin With Chemoradiation- 2550mg Cohort
n=8 participants at risk
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2550 mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin With Chemoradiation- 3000mg Cohort
n=4 participants at risk
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 3000 mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Blood and lymphatic system disorders
Creatinine Increased
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
Other adverse events
| Measure |
Metformin With Chemoradiation- 2000mg Cohort
n=6 participants at risk
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin With Chemoradiation- 2550mg Cohort
n=8 participants at risk
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 2550 mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
Metformin With Chemoradiation- 3000mg Cohort
n=4 participants at risk
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
Metformin: Escalating doses of 3000 mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
Cisplatin: Dosed at 100mg/m2 on days 1, 22, and 43
Radiation Therapy: 70 Gy in 2 Gy once daily fractions of 35 fractions
|
|---|---|---|---|
|
Metabolism and nutrition disorders
VB12 deficiency
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
2/8 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Renal and urinary disorders
Acute Kidney Disease
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
66.7%
4/6 • Number of events 5 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Hepatobiliary disorders
Creatinine increase
|
16.7%
1/6 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
75.0%
3/4 • Number of events 4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Dry Mouth
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Dysgeusia
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
3/6 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Ear and labyrinth disorders
Ear Pain
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
General disorders
Edema Trunk
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
75.0%
3/4 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
2/8 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Infections and infestations
Thrush
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Infections and infestations
Throat Swelling
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Investigations
Odynophagia
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Vascular disorders
Lymphedema
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Blood and lymphatic system disorders
Lymphocyte count increased
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
50.0%
4/8 • Number of events 4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Nervous system disorders
Nervous system disorders
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
General disorders
Pain
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Odgnophagia
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
1/4 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
2/8 • Number of events 5 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Stomach Pain
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
16.7%
1/6 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/8 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
2/6 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
50.0%
4/8 • Number of events 4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
75.0%
3/4 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Investigations
Weight Loss
|
0.00%
0/6 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
|
Investigations
White blood cell decreased
|
50.0%
3/6 • Number of events 3 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
0.00%
0/4 • Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.
|
Additional Information
Trisha Wise-Draper M.D., Ph.D., Associate Professor of Medicine, Medical Director of the UC Cancer C
University of Cincinnati
Phone: (513) 558-2826
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place