A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02321540|
Recruitment Status : Active, not recruiting
First Posted : December 22, 2014
Last Update Posted : June 16, 2020
The goal of Part 1 of this clinical research study is to find the highest dose of (Imbruvica) ibrutinib that can be given to patients with non-small cell lung cancer (NSCLC). The goal of Part 2 of this clinical research study is to learn if the dose of ibrutinib found in Part 1 can help to control the disease.
The safety of this drug will also be studied in both parts of the study.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Ibrutinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer|
|Actual Study Start Date :||March 31, 2015|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
Participants in Part 1 receive dose level of Ibrutinib depending on study joined. First group of participants receive lowest dose level of Ibrutinib. Each new group receives a higher dose of Ibrutinib than the group before it, if no intolerable side effects were seen. This continues until highest tolerable dose of Ibrutinib is found.
Participants in Part 2 receive Ibrutinib at highest dose that was tolerated in Part 1 or 840 mg daily.
Starting level of Ibrutinib: 560 mg by mouth daily in a 28 day cycle.
Part 1 Starting level of Ibrutinib: 560 mg by mouth daily in a 28 day cycle.
Part 2 Starting level of Ibrutinib: Maximum tolerated dose from Part 1 or 840 mg daily.
- Overall Response Rate [ Time Frame: 56 days ]Primary endpoint of this study is overall response rate using RECIST 1.1 criteria. Best overall response is best response recorded from start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since treatment started). Participant's best response assignment depends on achievement of both measurement and confirmation criteria.
- Disease Control Rate [ Time Frame: 8 weeks ]Disease control rate defined as rate of complete response + partial response + stable disease. Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321540
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||John Heymach, MD, PHD||M.D. Anderson Cancer Center|