Clinical Trials /

A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene

NCT02506517

Description:

This is a phase 2 study (the second phase in testing a new drug) to see how useful an investigational drug called afatinib is in patients with advanced cancer with changes in the HER gene. Afatinib is a drug that is approved by Health Canada for the treatment of advanced lung cancer with changes in the HER gene. Afatinib works by attaching to and blocking a protein called HER from working. HER is an important protein that contributes to the growth of cancer cells.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene
  • Official Title: Molecular Basket Trial In Multiple Malignancies With Common Target Pathway Aberrancies

Clinical Trial IDs

  • ORG STUDY ID: MOBILITY-003
  • NCT ID: NCT02506517

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
AfatinibGIOTRIFAfatinib

Purpose

This is a phase 2 study (the second phase in testing a new drug) to see how useful an investigational drug called afatinib is in patients with advanced cancer with changes in the HER gene. Afatinib is a drug that is approved by Health Canada for the treatment of advanced lung cancer with changes in the HER gene. Afatinib works by attaching to and blocking a protein called HER from working. HER is an important protein that contributes to the growth of cancer cells.

Trial Arms

NameTypeDescriptionInterventions
AfatinibExperimentalAfatinib, orally, at a dose of 40 mg once a day, every day of each 28 day cycle.
  • Afatinib

Eligibility Criteria

        Inclusion Criteria:

          -  Patients may have had any number of treatment lines in the curative or metastatic
             setting for their solid tumors.

          -  Age 18 years or older.

          -  At least one measurable lesion

          -  In patients with previous treatment, evidence of progression of cancer, as per the
             opinion of the investigator must be present

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1

          -  Adequate organ function

          -  Willingness to undergo fresh tumor biopsy at certain timepoints

          -  Recovered from any previous therapy related side effects

          -  Able to provide written consent

        Exclusion Criteria:

          -  Chemotherapy, biological therapy or investigational agents within 3 weeks prior to the
             start of study treatment.

          -  Hormonal treatment within 3 weeks prior to start of study treatment.

          -  Radiotherapy within 3 weeks prior to randomization with exceptions

          -  Major surgery within 3 weeks before starting study treatment or scheduled for surgery
             during the projected course of the study

          -  Known exposure to any epidermal growth factor receptor (EGFR), human epidermal growth
             factor receptor (HER) 2, HER3 or pan-HER inhibitors, such as, but not limited to
             afatinib or dacomitinib.

          -  Patients with inability to swallow whole tablets for afatinib are allowed on the
             study, but diluted tablets must be taken orally.

          -  Presence of malabsorption problems including, but not exclusively limited to chronic
             diarrhea and uncontrolled inflammatory bowel disease.

          -  History or presence of clinically relevant cardiovascular abnormalities such as
             uncontrolled hypertension, congestive heart failure, unstable angina or poorly
             controlled arrhythmia as determined by the investigator. Myocardial infarction within
             6 months prior to study entry

          -  Women of child-bearing potential (WOCBP) and men who are able to father a child,
             unwilling to be abstinent or use adequate contraception prior to study entry, for the
             duration of study participation and for at least 28 days after treatment has ended.

          -  Female patients of childbearing potential who are nursing or are pregnant or are not
             using an acceptable method of birth control, or do not plan to continue using this
             method throughout the study and/or do not agree to submit to pregnancy testing
             required by the study.

          -  Any history of or concomitant condition that, in the opinion of the Investigator,
             would compromise the patient's ability to comply with the study or interfere with the
             evaluation of the efficacy and safety of the study drug

          -  Previous or concomitant malignancies at other sites, with exceptions

          -  Requiring treatment with any of the prohibited concomitant medications

          -  Known pre-existing interstitial lung disease

          -  Any history or presence of poorly controlled gastrointestinal disorders.

          -  Known active hepatitis B, active hepatitis C infection and/or known HIV carrier.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients with complete response
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of Grade 1 side effects
Time Frame:2 years
Safety Issue:
Description:
Measure:Number of Grade 2 side effects
Time Frame:2 years
Safety Issue:
Description:
Measure:Number of Grade 3 side effects
Time Frame:2 years
Safety Issue:
Description:
Measure:Number of Grade 4 side effects
Time Frame:2 years
Safety Issue:
Description:
Measure:Timeframe of Progression Free Survival
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University Health Network, Toronto

Trial Keywords

  • HER pathway aberrations

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