Trial Outcomes & Findings for A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC (NCT NCT00882583)

Last Updated: 2019-01-09

Results Overview

The Maximum Tolerated Dose (MTD) for Dasatinib was defined as a) the dose producing DLT ( Dose limiting toxicity) in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in \<2 out of 6 patients, or c) the dose of 150mg PO QD with less than 33% rate of DLT.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

22 participants

Primary outcome timeframe

Last day of Radiation

Results posted on

2019-01-09

Participant Flow

A total of 22 patients were consented. One patient was a screen failure, one patient withdrew consent before initiating any treatment per protocol and patient was replaced in the run-in period before assignment to Cohort A.

Participant milestones

Participant milestones
Measure	Cohort A T2N0, T1-2N1 SCCHN There will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT). Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Radiation Therapy: Standard Radiation Therapy.	Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN There will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma (SCC) of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT. Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days Radiation Therapy: Standard Radiation Therapy.
Overall Study STARTED	7	12
Overall Study COMPLETED	6	11
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A T2N0, T1-2N1 SCCHN There will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT). Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Radiation Therapy: Standard Radiation Therapy.	Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN There will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma (SCC) of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT. Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days Radiation Therapy: Standard Radiation Therapy.
Overall Study Physician Decision	1	0
Overall Study Adverse Event	0	1

Baseline Characteristics

A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A n=7 Participants In both Cohort A and B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT). Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Radiation Therapy: Standard Radiation Therapy.	Cohort B n=12 Participants In both Cohort A and B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT. Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days Radiation Therapy: Standard Radiation Therapy.	Total n=19 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	58 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	12 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Last day of Radiation

Population: MTD not reached. Data table reports dosage received by each participant. Study closed to slow accrual.

Outcome measures

Outcome measures
Measure	Cohort A n=7 Participants In both Cohort A and B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT). Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Radiation Therapy: Standard Radiation Therapy.	Cohort B n=12 Participants In both Cohort A and B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT. Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days Radiation Therapy: Standard Radiation Therapy.
MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B Dose 70 mg	4 Participants	7 Participants
MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B Dose 100mg	3 Participants	3 Participants
MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B Dose 150mg	0 Participants	2 Participants

Adverse Events

Cohort A

Serious events: 1 serious events

Other events: 7 other events

Deaths: 1 deaths

Cohort B

Serious events: 5 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A n=7 participants at risk In both Cohort A and B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT). Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Radiation Therapy: Standard Radiation Therapy.	Cohort B n=12 participants at risk In both Cohort A and B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT. Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days Radiation Therapy: Standard Radiation Therapy.
Respiratory, thoracic and mediastinal disorders hypoxia	14.3% 1/7 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	0.00% 0/12 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Renal and urinary disorders acute renal failure	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	16.7% 2/12 • Number of events 2 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
General disorders dehydration	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	16.7% 2/12 • Number of events 2 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
General disorders Sepsis	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Blood and lymphatic system disorders thrombocytopenia	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
General disorders hypophosphatemia	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Cardiac disorders Atrial Fibrillation	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Infections and infestations Febrile neutropenia	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Respiratory, thoracic and mediastinal disorders pneumonia	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Infections and infestations bacteremia	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.

Other adverse events

Additional Information

Shanthi Marur

FDA

Phone: 2404026373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort A n=7 participants at risk In both Cohort A and B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT). Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Radiation Therapy: Standard Radiation Therapy.	Cohort B n=12 participants at risk In both Cohort A and B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14. Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT. Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 Dasatinib: Oral Dasatinib Days 8 through 64. Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days Radiation Therapy: Standard Radiation Therapy.
Gastrointestinal disorders Peg tube site pain	85.7% 6/7 • Number of events 6 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	33.3% 4/12 • Number of events 4 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Gastrointestinal disorders Nausea	85.7% 6/7 • Number of events 6 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	91.7% 11/12 • Number of events 11 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Gastrointestinal disorders Vomiting	42.9% 3/7 • Number of events 3 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	66.7% 8/12 • Number of events 8 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Gastrointestinal disorders Constipation	71.4% 5/7 • Number of events 5 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	83.3% 10/12 • Number of events 10 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Skin and subcutaneous tissue disorders Rash	85.7% 6/7 • Number of events 6 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	100.0% 12/12 • Number of events 12 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
General disorders Fatigue	71.4% 5/7 • Number of events 5 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	91.7% 11/12 • Number of events 11 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Gastrointestinal disorders Diarrhea	28.6% 2/7 • Number of events 2 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	66.7% 8/12 • Number of events 8 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Gastrointestinal disorders Dysguesia	57.1% 4/7 • Number of events 4 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	83.3% 10/12 • Number of events 10 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	33.3% 4/12 • Number of events 4 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Skin and subcutaneous tissue disorders Radiation Dermatitis	71.4% 5/7 • Number of events 7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	58.3% 7/12 • Number of events 7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Gastrointestinal disorders Dysphagia	71.4% 5/7 • Number of events 5 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	58.3% 7/12 • Number of events 7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Blood and lymphatic system disorders Deep Vein Thrombosis	14.3% 1/7 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	0.00% 0/12 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
General disorders Dry mouth	85.7% 6/7 • Number of events 6 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	66.7% 8/12 • Number of events 8 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Infections and infestations Fever	14.3% 1/7 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	41.7% 5/12 • Number of events 5 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
General disorders oral mucositis	85.7% 6/7 • Number of events 6 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	91.7% 11/12 • Number of events 11 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Hepatobiliary disorders elevated AST	14.3% 1/7 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Hepatobiliary disorders elevated ALT	14.3% 1/7 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Infections and infestations abcess	14.3% 1/7 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Gastrointestinal disorders hemetemesis	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Ear and labyrinth disorders hearing loss	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
General disorders hypophosphatemia	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	16.7% 2/12 • Number of events 2 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
General disorders hypomagnesemia	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	16.7% 2/12 • Number of events 2 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.
Metabolism and nutrition disorders hypoalbuminemia	0.00% 0/7 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.	8.3% 1/12 • Number of events 1 • From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up. This study utilized the Cancer Therapy Evaluation Program Common Toxicity criteria (CTC) version 3.0 for toxicity and event reporting. Dose limiting toxicities were observed until patients completed radiation therapy.