Neoplasms
Conditions
Brief summary
The primary objective was to collect safety data for BIBW 2992.
Interventions
DRUGBIBW 2992
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients who have completed the prescribed courses of the 1200.1 or 1200.2 studies without clinical disease progression * Age 18 years or older * Life expectancy of at least three (3) months * Written informed consent that is consistent with International Conference on Harmonization - Good Clinical Practice guidelines * Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2 * Patients must be recovered from previous surgery
Exclusion criteria
* Active infectious disease * Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea * Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol * Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least eight (8) weeks, no history of cerebral edema or bleeding in the past eight (8) weeks and no requirement for steroids or anti-epileptic therapy * Cardiac left ventricular function with resting ejection fraction \>= CTC Grade 1 * Absolute neutrophil count (ANC) less than 1500 / mm3 * Platelet count less than 100 000 / mm3 * Bilirubin greater than 1.5 mg / dl (\> 26 μmol / L, Systeme International (SI) unit equivalent) * Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) * Serum creatinine greater than 1.5 mg / dl (\> 132 μmol / L, SI unit equivalent) * Women and men who are sexually active and unwilling to use a medically acceptable method of birth control * Pregnancy or breast-feeding * Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (excluding Luteinizing hormone-releasing hormone agonists, or other hormones taken for breast cancer, or bisphosphonates), or participation in a clinical study other than 1200.1 or 1200.2 * Patients unable to comply with the protocol * Active alcohol or drug abuse * Patients not recovered from any dose-limiting toxicity The patients are eligible for re-treatment after the previous course is finished. Patients will not be eligible if the following conditions are met: * Patients with clinical signs of disease progression or if latest X-ray, CT, MRI or US reveals progressive disease * Cardiac left ventricular function CTC Grade ≥ 2 at any time during the previous course * Patients fulfilling any of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of Adverse Events, according to Common Terminology Criteria (CTC) version 3, with particular scrutiny of events that were considered to be dose-limiting toxicities and those that were serious or significant | up to 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Durability of non-progression as measured by tumor assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) | every 8 weeks up to 18 months |
Outcome results
None listed