BIBW 2992 in Patients With Advanced Solid Tumors

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: BIBW 2992

Study type

Interventional

Funder types

Industry

Identifiers

NCT02171650

1200.17

Details and patient eligibility

About

The primary objective was to collect safety data for BIBW 2992.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 Exclusion Criteria listed in Section 3.3 on Day 29 of the previous course
Patient not recovered from any dose-limiting toxicity (DLT) 14 days after the last administration of BIBW2992 in the previous course. Recovery is defined as return to baseline condition (Visit 1 of 1200.1 or Visit 1 of 1200.2) or CTC Grade 1, whichever is higher.