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BIBW 2992 Phase I Combination With Pemetrexed in Advanced Solid Tumours


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

BIBW 2992 Phase I Combination With Pemetrexed in Advanced Solid Tumours

Inclusion Criteria


Inclusion criteria:

1. Age 18 or older.

2. Eastern cooperative oncology group performance status of 0-2.

3. Life expectancy of at least 12 weeks.

4. Measurable disease according to Response evaluation criteria in solid tumors 1.1
criteria.

5. Written informed consent

Exclusion criteria:

1. Treatment with an investigational drug within the past 28 days prior to the start of
therapy

2. Persisting toxicities which are clinically significant from previous therapy

3. Patients who are unwilling or unable to take folic acid and vitamin B12
supplementation

4. Active brain metastases

5. Other active malignancy diagnosed within the past 3 years

6. Concomitant intercurrent illnesses that would limit compliance with trial requirement

7. Patients unable or unwilling to interrupt concomitant administration of Non-steroidal
anti-inflammatory drugs (NSAIDS) as per pemetrexed prescribing information

8. Patients who have received prior therapy with BIBW 2992

9. Left ventricular function by echocardiogram or Multiple gated acquisition scan (MUGA)
less than institutional lower limit of normal

10. Absolute neutrophil count (ANC) less than 1,500/mm3

11. Platelet count less than 100,000/mm3

12. Hemoglobin less than 90g/L

13. Total bilirubin less than 26┬Ámol/L

14. 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

15. Serum creatinine level greater than 133┬Ámol/L and/or creatinine clearance (measured
or calculated) less than 45 ml/min

16. History or recent gastrointestinal bleeding, obstruction or perforation or
malabsorption syndrome and must be able to swallow the BIBW 2992 in whole by mouth.

17. History of interstitial lung disease

18. Women and men who are sexually active and unwilling to use a medically acceptable
method of contraception

19. Pregnancy or breast feeding

20. Known or suspected active alcohol or drug abuse

21. Patients unable to comply with the protocol

22. Has a diagnosis of human immunodeficiency virus (HIV) infection or acquired
immunodeficiency syndrome (AIDS).

23. Any known hypersensitivity to the trial drugs or their excipients

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and maximum tolerated dose (MTD) of BIBW 2992 at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).

Outcome Time Frame:

20 weeks

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Canada: Health Canada

Study ID:

1200.92

NCT ID:

NCT01169675

Start Date:

July 2010

Completion Date:

November 2012

Related Keywords:

  • Neoplasms
  • Neoplasms

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