BIBW 2992 (Afatinib) in Combination With Pemetrexed in Advanced Solid Tumours

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 given on two different dose schedules; dosing on days 1-21 and dosing on days 1 to 6 of a 21 day cycle.

The use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), including BIBW 2992 have demonstrated efficacy in solid tumors including non-small cell lung cancer (NSCLC). In addition, pemetrexed has demonstrated efficacy and has been approved as single agent chemotherapy in second-line NSCLC patients with adenocarcinoma. The data obtained from this trial shall allow for a conclusion as to whether BIBW 2992 may be safely administered in advanced cancer patients in combination therapy with pemetrexed.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dose Escalation Study of Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors

NCT02171637

Neoplasms

COMPLETED PHASE1

Phase I of BIBW 2992/BIBF 1120 Combination Therapy in Solid Tumors

NCT00730821

Neoplasms

COMPLETED PHASE1

BIBW 2992 in Patients With Advanced Solid Tumors

NCT02171650

Neoplasms

COMPLETED PHASE1

Dose Escalation Study of BIBW 2992 in Patients With Advanced Solid Tumors

NCT02171663

Neoplasms

COMPLETED PHASE1

Dose Escalation Study of Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumours

NCT02171702

Neoplasms

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BIBW 2992 low dose

patient receives low dose tablet BIBW 2992 po daily plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle

Group Type EXPERIMENTAL

BIBW 2992 low dose

Intervention Type DRUG

patient receives low dose BIBW 2992 po daily on day 1 of 21 day cycle

pemetrexed

Intervention Type DRUG

given intravenously on day 1 of a 21 day cycle

BIBW 2992 medium dose

patient receives medium dose BIBW 2992 po daily plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

given intravenously on day 1 of a 21 day cycle

BIBW 2992 medium dose

Intervention Type DRUG

patient receives medium dose BIBW 2992 po daily on day 1 of 21 day cycle

BIBW 2992 high dose

patient receives high dose BIBW 2992 po daily plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle

Group Type EXPERIMENTAL

BIBW 2992 high dose

Intervention Type DRUG

patient receives high dose BIBW 2992 po daily on day 1 of 21 day cycle

pemetrexed

Intervention Type DRUG

given intravenously on day 1 of a 21 day cycle

BIBW 2992 low dose 6 day

patient receives low dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

given intravenously on day 1 of a 21 day cycle

BIBW 2992 low dose 6 day

Intervention Type DRUG

patient receives low dose BIBW 2992 po daily on days 1-6 on day 1 of 21 day cycle

BIBW 2992 medium dose 6 day

patient receives medium BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

given intravenously on day 1 of a 21 day cycle

BIBW 2992 medium dose 6 day

Intervention Type DRUG

patient receives medium dose BIBW 2992 po daily on day1 to 6 of a 21 day cycle

BIBW 2992 high dose 6 day

patient receives high dose BIBW 2992 po daily on days 1-6 plus pemetrexed 500mg/m\^2 on day 1 of 21 day cycle

Group Type EXPERIMENTAL

BIBW 2992 high dose 6 day

Intervention Type DRUG

patient receives high dose BIBW 2992 po daily on days 1-6 on 1 of 21 day cycle

pemetrexed

Intervention Type DRUG

given intravenously on day 1 of a 21 day cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BIBW 2992 low dose

patient receives low dose BIBW 2992 po daily on day 1 of 21 day cycle

Intervention Type DRUG

BIBW 2992 high dose

patient receives high dose BIBW 2992 po daily on day 1 of 21 day cycle

Intervention Type DRUG

pemetrexed

given intravenously on day 1 of a 21 day cycle

Intervention Type DRUG

pemetrexed

given intravenously on day 1 of a 21 day cycle

Intervention Type DRUG

BIBW 2992 high dose 6 day

patient receives high dose BIBW 2992 po daily on days 1-6 on 1 of 21 day cycle

Intervention Type DRUG

pemetrexed

given intravenously on day 1 of a 21 day cycle

Intervention Type DRUG

pemetrexed

given intravenously on day 1 of a 21 day cycle

Intervention Type DRUG

pemetrexed

given intravenously on day 1 of a 21 day cycle

Intervention Type DRUG

pemetrexed

given intravenously on day 1 of a 21 day cycle

Intervention Type DRUG

BIBW 2992 low dose 6 day

patient receives low dose BIBW 2992 po daily on days 1-6 on day 1 of 21 day cycle

Intervention Type DRUG

BIBW 2992 medium dose 6 day

patient receives medium dose BIBW 2992 po daily on day1 to 6 of a 21 day cycle

Intervention Type DRUG

BIBW 2992 medium dose

patient receives medium dose BIBW 2992 po daily on day 1 of 21 day cycle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 26µmol/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 133µmol/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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No