Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting

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: NCT02271906
Recruitment Status : Terminated (Poor Accrual)
First Posted : October 22, 2014
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if it is tolerable for patients with NSCLC to receive afatinib before surgery. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: BIBW 2992 Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : August 16, 2017
Actual Study Completion Date : August 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIBW 2992
BIBW 2992 40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.
Drug: BIBW 2992
40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.




Primary Outcome Measures :
  1. Number of Patients With Treatment "Completed" [ Time Frame: From the start of neoadjuvant treatment to 30 days post operative care ]
    A patient is declared to have the treatment "completed" if he completes at least 14 days of neoadjuvant treatment, had a thoracotomy for the planned surgical resection, and 30 days of post operative care.


Secondary Outcome Measures :
  1. Number of Participants With a Change in Standard Uptake Value (SUV) From Pre to Post Operative PET-CT [ Time Frame: From the start of neoadjuvant treatment to follow-up, up to 30 days post surgery ]
    To determine whether pre-operative Afatinib treatment affects metabolic tumor labeling, as measured by PET-CT scanning.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Histologically confirmed NSCLC, who are deemed to be surgical candidates by standard criteria. Patients with all types of NSCLC (e.g., adenocarcinoma, squamous cell carcinoma) will be allowed to enroll.
  2. Patients with Stage IA to IIB disease. Select patients with resectable stage IIIA disease (T3N1, T4N0, T4N1) will also be eligible if approved by the PI.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  4. Measurable disease by RECIST 1.1 criteria
  5. Mediastinoscopy and/or Endoscopic Bronchial Ultrasound (EBUS) and/or Endoscopic Ultrasound (EUS) for complete surgical staging when clinically indicated
  6. Serious, active infections must be controlled. Patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved.
  7. A signed informed consent document (ICD)
  8. Patients 18 years or older
  9. Able and willing to take oral medications

Exclusion Criteria:

  1. Known preexisting interstitial lung disease, interstitial pulmonary fibrosis, or connective tissue disorder associated lung disease
  2. Known N2 nodal disease or distant metastatic disease
  3. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
  4. Patients with any of the following lab values at screening should be excluded: Absolute neutrophil count (ANC) < 1500 / mm^3; Platelet count < 100,000 / mm^3; Serum creatinine >/= 1.5 times the upper normal limit or calculated/measured creatinine clearance </= 60 mL/min; Bilirubin >/=1.5mg/dL (> 26 mol/L, SI unit equivalent); Aspartate amino transferase (AST) or Alanine amino transferase (ALT) >/= three (3) times the upper limit of normal.
  5. Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
  6. Known or suspected active drug or alcohol abuse
  7. Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom for example Crohn's disease, malabsorption or CTC grade >/= 2 diarrhea of any etiology.
  8. Baseline (< 1 month before treatment) cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
  9. Patients receiving other investigational agent.
  10. History of allergic reactions to anilinoquinazolins like gefitinib, erlotinib, or BIBW2992
  11. Uncontrolled intercurrent illness that would preclude a patient from undergoing surgery
  12. Psychiatric illness/social situations that would limit compliance with study requirements
  13. Pregnant (positive pregnancy test) or lactating
  14. Inability to comply with study and/or follow-up procedures
  15. Patients who are not surgical candidates or refuse surgery

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): NCT02271906


Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Boehringer Ingelheim
Investigators
Layout table for investigator information
Principal Investigator: George Simon, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02271906    
Other Study ID Numbers: 2013-0305
NCI-2015-00357 ( Registry Identifier: NCI CTRP )
First Posted: October 22, 2014    Key Record Dates
Results First Posted: April 30, 2019
Last Update Posted: April 30, 2019
Last Verified: April 2019

Layout table for additional information
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
Adenocarcinoma
Squamous cell carcinoma
BIBW 2992
Afatinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action