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Status:

COMPLETED

Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Carcinoma, Non-Small-Cell Lung

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after o...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Pathologic or cytologic confirmed diagnosis of NSCLC
  • Recurrent, advanced or metastatic NSCLC that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)
  • Patients who are eligible for pemetrexed as second line chemotherapy
  • Measurable disease by one or more techniques (CT, MRI) according to RECIST
  • Patients aged 18 years or older
  • Life expectancy of at least three (3) months
  • Eastern Cooperative Oncology Group (ECOG) performance Score 0-2
  • Written informed consent that is consistent with ICH-GCP guidelines and local legislation
  • Exclusion criteria:
  • Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
  • Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of Cycle 1 of this trial
  • Any persisting toxicities which are deemed to be clinically significant from the previous therapy
  • Patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors.
  • Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
  • Active brain metastases (stable for \<28 days, symptomatic, or requiring concurrent steroids). Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded.
  • Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
  • Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
  • Patients unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily
  • Patients who have received prior therapy with pemetrexed
  • Absolute neutrophil count (ANC) less than 1,500/mm3
  • Platelet count less than 100,000/mm3
  • Hemoglobin \<90g/L
  • Total bilirubin \>26µmol/L
  • Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) less than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable
  • Serum creatinine level \>133µmol/L and/or creatinine clearance (measured or calculated) \<45 ml/min
  • Clinically relevant QTc prolongation
  • Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  • Pregnancy or breast feeding
  • Known or suspected active alcohol or drug abuse
  • Patients unable to comply with the protocol
  • Any known hypersensitivity to the trial drugs or their excipients
  • Patients with NSCLC of confirmed Squamous histology

Exclusion

    Key Trial Info

    Start Date :

    March 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2015

    Estimated Enrollment :

    143 Patients enrolled

    Trial Details

    Trial ID

    NCT00824408

    Start Date

    March 1 2009

    End Date

    August 1 2015

    Last Update

    September 20 2016

    Active Locations (12)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    1

    1230.5.00104 Boehringer Ingelheim Investigational Site

    Edmonton, Alberta, Canada

    2

    1230.5.00114 Boehringer Ingelheim Investigational Site

    Kelowna, British Columbia, Canada

    3

    1230.5.00109 Boehringer Ingelheim Investigational Site

    Surrey, British Columbia, Canada

    4

    1230.5.00107 Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia, Canada