Status:
COMPLETED
BIBW 2992 (Afatinib) in Combination With Pemetrexed in Advanced Solid Tumours
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This Phase I study will investigate the safety of BIBW 2992 in combination with standard dose pemetrexed (500mg/m2) given on a 21 day cycle in patients with advanced solid cancers. BIBW 2992 will be g...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 18 or older.
- Eastern cooperative oncology group performance status of 0-2.
- Life expectancy of at least 12 weeks.
- Measurable disease according to Response evaluation criteria in solid tumors 1.1 criteria.
- Written informed consent
- Exclusion criteria:
- Treatment with an investigational drug within the past 28 days prior to the start of therapy
- Persisting toxicities which are clinically significant from previous therapy
- Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
- Active brain metastases
- Other active malignancy diagnosed within the past 3 years
- Concomitant intercurrent illnesses that would limit compliance with trial requirement
- Patients unable or unwilling to interrupt concomitant administration of Non-steroidal anti-inflammatory drugs (NSAIDS) as per pemetrexed prescribing information
- Patients who have received prior therapy with BIBW 2992
- Left ventricular function by echocardiogram or Multiple gated acquisition scan (MUGA) less than institutional lower limit of normal
- Absolute neutrophil count (ANC) less than 1,500/mm3
- Platelet count less than 100,000/mm3
- Hemoglobin less than 90g/L
- Total bilirubin less than 26µmol/L
- Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) greater than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable
- Serum creatinine level greater than 133µmol/L and/or creatinine clearance (measured or calculated) less than 45 ml/min
- History or recent gastrointestinal bleeding, obstruction or perforation or malabsorption syndrome and must be able to swallow the BIBW 2992 in whole by mouth.
- History of interstitial lung disease
- 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
- Has a diagnosis of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Any known hypersensitivity to the trial drugs or their excipients
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01169675
Start Date
July 1 2010
End Date
November 1 2012
Last Update
June 9 2014
Active Locations (2)
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1
1200.92.1001 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
2
1200.92.1002 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada