Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:December 26, 2011
End Date:May 18, 2015

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ARCHER 1042: A PHASE 2 STUDY OF DACOMITINIB IN ADVANCED NON-SMALL CELL LUNG CANCER (POST-CHEMOTHERAPY OR SELECT FIRST LINE PATIENTS) TO EVALUATE PROPHYLACTIC INTERVENTION ON DERMATOLOGIC AND GASTROINTESTINAL ADVERSE EVENTS AND PATIENT REPORTED OUTCOMES

To assess the impact of prophylactic treatment on the incidence of adverse events in advanced
NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To
assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence
of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1
mutation, HER-2 mutation or HER-2 amplification).


Inclusion Criteria:

- Advanced Non-Small Cell Lung Cancer (NSCLC).

- For Cohort I and Cohort II, advanced NSCLC patients must have received at least one
prior regimen of systemic therapy which includes at least one standard chemotherapy
for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity
which precludes further treatment) standard therapy for advanced or metastatic
disease. To be considered intolerant to treatment, a patient must have received at
least two cycles to be considered previously treated.

- For Cohort III, advanced NSCLC patients must not have received prior systemic
treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2
mutation or HER-2 amplification. Cohort III patients could have received prior
adjuvant chemotherapy for Stage I-III disease or combined modality
chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed>12
months prior to enrollment.

- All cohorts, patients must have evidence of disease; however, measurable disease is
not required to enroll.

- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

- Estimated creatinine clearance ≥15 mL/min.

Exclusion Criteria:

- Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).

- Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of
baseline disease assessments (all cohorts).

- Patients with known diffuse interstitial lung disease (all cohorts).

- Investigational therapy as only treatment for advanced NSCLC without administration of
an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)
We found this trial at
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931 S. 9th Street
Bismarck, North Dakota 58504
701-530-6954
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601 N. 5th Street
Bismarck, North Dakota 58501
701-751-1128
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
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Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Holy Cross Hospital's Michael...
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3700 Johnson Street
Hollywood, Florida 33021
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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220 S Palisade Dr # 204
Santa Maria, California 93454
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900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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Brownstown, Michigan 48183
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Charleston, South Carolina 29403
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5841 S Maryland Ave
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Corinth, Mississippi 38834
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Dearborn, Michigan 48126
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Denver, Colorado 80205
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Duarte, California 91010
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fort Worth, Texas 76177
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Fullerton, California 92835
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Grand Junction, Colorado 81501
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Hickory, North Carolina 28602
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Irvine, California 92604
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Issaquah, Washington 98029
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3855 Health Sciences Dr,
La Jolla, California 92093
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Lafayette, Colorado 80026
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Lake City, Florida 32024
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Lonetree, Colorado 80124
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100 N Humphreys Blvd
Memphis, Tennessee 38120
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Seattle, Washington 98104
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Southaven, Mississippi 38671
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1235 E Cherokee St
Springfield, Missouri 65804
(417) 820-2000
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Valencia, California 91355
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Westlake Village, California 91361
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818 N. Emporia, #403
Wichita, Kansas 67214
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818 N. Emporia, #403
Wichita, Kansas 67214
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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