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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cohort I: Incidence of all-causality, all grade and grade ≥2 select dermatologic adverse events of interest (SDAEI) in the first 8 weeks of treatment by arm.

Outcome Time Frame:

10 months

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A7471042

NCT ID:

NCT01465802

Start Date:

December 2011

Completion Date:

August 2014

Related Keywords:

  • Non Small Cell Lung Cancer (NSCLC)
  • non-small cell lung cancer
  • advanced
  • previously treated
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteBurlington, Vermont  05401-3456
Pfizer Investigational SiteBismarck, North Dakota  58503