Trial Outcomes & Findings for A Study of Dasatinib With Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00787852)
NCT ID: NCT00787852
Last Updated: 2014-07-30
Results Overview
6 patients came off study for toxicity
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
within 28 days after the last radiation treatment
Results posted on
2014-07-30
Participant Flow
First patient enrolled 3/25/09 and last patient was enrolled 1/4/11. 11 patients enrolled, 10 were treated secondary to 1 patient withdrawing prior to treatment.
Participant milestones
| Measure |
Group 1: Dasatinib 50mg
DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43
Dasatinib is to be taken 1x daily 50 mg daily
Maintenance x 2 years\*
|
Group 2: Dasatinib 70mg
DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib \& Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43
Dasatinib is to be taken 1x daily 70 mg daily
Maintenance x 2 years\*
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Dasatinib With Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Group 1
n=11 Participants
DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years\* Dasatinib is to be taken 1x daily
1. 50 mg daily 100 mg daily
2. 70 mg daily 100 mg daily
3. 100 mg daily 100 mg daily
|
Group 2
Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,
Dasatinib Dose Level With chemoradiation Maintenance x 2 years\* Dasatinib is to be taken 1x daily
1. 50 mg daily 100 mg daily
2. 70 mg daily 100 mg daily
3. 100 mg daily 100 mg daily
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 participants
n=5 Participants
|
—
|
6 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 participants
n=5 Participants
|
—
|
5 participants
n=5 Participants
|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 5.38 • n=5 Participants
|
—
|
65.5 years
STANDARD_DEVIATION 5.38 • n=5 Participants
|
|
Gender
Female
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
|
Gender
Male
|
8 participants
n=5 Participants
|
—
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
—
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 28 days after the last radiation treatment6 patients came off study for toxicity
Outcome measures
| Measure |
Group 1
n=10 Participants
DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years\* Dasatinib is to be taken 1x daily
1. 50 mg daily 100 mg daily
2. 70 mg daily 100 mg daily
3. 100 mg daily 100 mg daily
|
Group 2
Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,
Dasatinib Dose Level With chemoradiation Maintenance x 2 years\* Dasatinib is to be taken 1x daily
1. 50 mg daily 100 mg daily
2. 70 mg daily 100 mg daily
3. 100 mg daily 100 mg daily
|
|---|---|---|
|
Number of Patients Who Came Off Study for Toxicity Using CTC Version 3.0
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: within 30 days of last treatmentOutcome measures
Outcome data not reported
Adverse Events
Group 1
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=5 participants at risk
DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years\* Dasatinib is to be taken 1x daily 50 mg daily
|
Group 2
n=5 participants at risk
DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years\* Dasatinib is to be taken 1x daily
70 mg daily
|
|---|---|---|
|
Investigations
pt # 5: troponin and chest pain (4), cardiac ischemia (3), allergic reaction (2)
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
pt #7: hypotension, diarrhea, SVT/arrythmia (2), hypokalemia and hypomagnesmia (1)
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
pt #7: pleural effusion and pericardial effusion (3)
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
pt #8: radiation esophagitis and pain (3)
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
pt 10: pneumonitis/pulmonary infiltrates (4)- definitely related to Dasatinib,
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
pt #11: infection normal ANC (penumonia) (3)
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
pt #2: right leg pain
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
Other adverse events
| Measure |
Group 1
n=5 participants at risk
DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years\* Dasatinib is to be taken 1x daily 50 mg daily
|
Group 2
n=5 participants at risk
DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years\* Dasatinib is to be taken 1x daily
70 mg daily
|
|---|---|---|
|
Investigations
ANC
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
anorexia
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
altered eating
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
altered taste
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
anxiety
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
constipation
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
cough
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
dehydration
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
60.0%
3/5 • Number of events 3 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
diarrhea
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
dyspnea
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
dyspepsia
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
dysphagia
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
60.0%
3/5 • Number of events 3 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
epistaxis
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
esophagitis
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
erythema
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
fatigue
|
60.0%
3/5 • Number of events 3 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
60.0%
3/5 • Number of events 3 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
gynecomastis
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
HGB
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
heartburn
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
hoarseness
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
hypotension
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
lymphopenia
|
80.0%
4/5 • Number of events 4 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
Nausea
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
60.0%
3/5 • Number of events 3 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
pain
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
phosphorus
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
pleural effusion
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
radiation dermatitis
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
rash
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
vomiting
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
WBC
|
40.0%
2/5 • Number of events 2 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
0.00%
0/5 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
|
Investigations
wt loss
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
20.0%
1/5 • Number of events 1 • Baseline then approximately 30 days post the last dose of drug, which could be up to 2.5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place