Trial Outcomes & Findings for Phase II Study Evaluating The Safety And Response To Neoadjuvant Dasatinib In Early Stage Non-Small Cell Lung Cancer (NCT NCT00564876)
NCT ID: NCT00564876
Last Updated: 2015-02-23
Results Overview
Response rate (radiologic and pathologic) in Stage IB and II to neoadjuvant dasatinib
TERMINATED
PHASE2
2 participants
First progression and survival every 3 months for 2 years, then every 6 months until 5 years, then yearly.
2015-02-23
Participant Flow
Due to poor enrollment, this trial was closed to accrual and thus no results came from this trial.
Participant milestones
| Measure |
Neoadjuvant Dasatinib
Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
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|---|---|
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Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study Evaluating The Safety And Response To Neoadjuvant Dasatinib In Early Stage Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Dasatinib
n=2 Participants
Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
|
Dasatinib
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First progression and survival every 3 months for 2 years, then every 6 months until 5 years, then yearly.Response rate (radiologic and pathologic) in Stage IB and II to neoadjuvant dasatinib
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening / Baseline; Neoadjuvant dasatinib Cycle 1 Day 1 and Day 22Population: Due to insufficient accrual, data analysis was not performed.
Determine the safety and tolerability of neoadjuvant dasatinib in early stage NSCLC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and after 3 weeks of dasatinib therapy at the time of definitive surgical resection.Population: Due to insufficient accrual, data analysis was not performed.
Determine whether gene expression profile activation of Src pathways is correlated with anti-tumor activity of dasatinib in early stage NSCLC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of adjuvant treatment plus 30 days.Population: Due to insufficient accrual, data analysis was not performed.
Determine the safety and tolerability of adjuvant dasatinib in early stage NSCLC.
Outcome measures
Outcome data not reported
Adverse Events
Neoadjuvant Dasatinib
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place