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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 (ARCHER 1042)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01465802
First received: October 20, 2011
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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).


Condition Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Drug: Dacomitinib Plus Blinded Doxycycline or Placebo
Drug: Dacomitinib Plus Probiotic Plus Topical Alclometasone cream
Drug: Dacomitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Cohort II: Incidence of all-causality, all grade and grade ≥2 diarrhea adverse events in the first 8 weeks of treatment. Incidence of all-causality, all grade and grade ≥2 select dermatologic adverse events of interest (SDAEI) in [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  • the first 8 weeks of treatment by arm. [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  • Cohort I:Skindex-16 Scale scores (Total score, Symptoms score, Emotions score, Functioning score) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cohort II: Mucositis Daily Questionaire (diarrhea questions) Skindex-16 Scale scores (Total score, Symptoms score, Emotions score, Functioning score) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Cohort III: Pharmacokinetics of PF-00299804 and PF-05199265 metabolite Cohort 3 primary PK endpoints include: Parent and metabolite: AUC0-120, AUC0-24, Cmax, Tmax [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall safety profile as characterized by type, frequency, severity of adverse events as graded by NCI CTCAE.v4, timing and relationship to treatment on each arm, laboratory abnormalities observed, and left ventricular imaging observed. [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
  • Concomitant medication (both prescribed and non-prescription) used for dermatologic AEs of interest, diarrhea, and mucositis. [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Trough concentrations (Ctrough) of PF-00299804 and PF-05199265, as determined from trough plasma samples. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 184
Study Start Date: December 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort I
Cohort I is a dermatologic intervention cohort that will randomize to 2 separate arms (blinded doxycycline placebo; blinded doxycycline)
Drug: Dacomitinib Plus Blinded Doxycycline or Placebo
Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent PLUS doxycycline or doxycycline placebo BID for 4 weeks
Experimental: Cohort II
Cohort II is a single arm with dacomitinib 45 mg daily PLUS probiotic PLUS topical alclometasone
Drug: Dacomitinib Plus Probiotic Plus Topical Alclometasone cream
Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent PLUS Probiotic PLUS topical Alclometasone cream
Experimental: Cohort III
Cohort III is an interrupted dosing schedule of dacomitinib in the first cycle only
Drug: Dacomitinib
Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465802

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 100 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01465802     History of Changes
Other Study ID Numbers: A7471042
Study First Received: October 20, 2011
Last Updated: November 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
non-small cell lung cancer
advanced
previously treated

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Alclometasone dipropionate
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014