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Trial record 27 of 307 for:    IBRUTINIB

A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02321540
Recruitment Status : Active, not recruiting
First Posted : December 22, 2014
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
Pharmacyclics LLC.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Ibrutinib

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.

Drug: Ibrutinib

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.

Other Names:
  • PCI-32765
  • Imbruvica




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed stage IV non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy.
  2. Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 criteria
  3. For EGFR mutant cohort, patients must have: a) Documented EGFR mutation by Clinical Laboratory Improvement Amendments (CLIA)-certified test b) Documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other EGFR-targeted tyrosine kinase inhibitor c) Tissue available from a biopsy or surgical procedure performed after progression on an EGFR targeted tyrosine kinase inhibitor. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy.
  4. For HER2 mutant cohort, patients must have: a) Documented EGFR mutation by CLIA-certified test b)Documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other EGFR-targeted tyrosine kinase inhibitor c)Tissue available following progression on most recent systemic therapy. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy.
  5. Age >/=18 years
  6. Eastern Cooperative Oncology Group (ECOG) performance status </=2
  7. Ability to take pills by mouth
  8. Patients must have normal organ and marrow function as defined: leukocytes >/= 3,000/mcL; absolute neutrophil count >/= 1,500/mcL; hemoglobin >/= 9 g/dL; total bilirubin </= 1.5 x institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) </= 2.5 × ULN or </= 5 x ULN if metastases to the liver; creatinine clearance >/= 45 mL/min
  9. Patients with asymptomatic brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids. Maximum daily dose of steroids should be prednisone 20 mg or equivalent. Radiation therapy for brain metastases must be completed at least 14 days prior to treatment on protocol
  10. The effects of ibrutinib on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use highly effective contraception (if using hormonal birth control must add a second barrier method; abstinence) prior to study entry, for the duration of study participation as well as for at least 1 month after the last dose of ibrutinib. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use highly effective contraception prior to the study, for the duration of study participation and 3 months after completion of ibrutinib administration.
  11. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. Patients who have received EGFR tyrosine kinase inhibitors within 72 hours of initiation of study treatment, or treatment with other anti-cancer agents within 21 days of study treatment
  2. Prior treatment with ibrutinib
  3. Known hypersensitivity to ibrutinib
  4. Concurrent use of agents that strongly inhibit or induce CYP3A unless use is approved by the medical monitor
  5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  6. Pregnant and nursing women
  7. Patients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapy
  8. Any gastrointestinal disorder expected to limit absorption of ibrutinib
  9. Treatment with warfarin or other vitamin K antagonist. Patients with using warfarin who switch to another form of anticoagulation will be eligible
  10. Patients with persistent and uncontrolled atrial fibrillation.

Information from the National Library of Medicine

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


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pharmacyclics LLC.
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John Heymach, MD, PHD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02321540     History of Changes
Other Study ID Numbers: 2014-0602
NCI-2015-00124 ( Registry Identifier: NCI CTRP )
1R01CA190628 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Non-small cell lung cancer
NSCLC
Epidermal growth factor receptor mutations
EGFR
Recurrent non-small cell lung cancer
Ibrutinib
PCI-32765
Imbruvica

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action