Dose Escalation Trial of BIBW 2992 Administration in Combination With Docetaxel in Patients With Advanced Solid Tumors

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: BIBW 2992

Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02171741

1200.6

Details and patient eligibility

About

Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW 2992 when administered in combination with docetaxel as determined by drug-related adverse events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients with confirmed diagnosis of advanced, non-resectable and / or metastatic solid tumors, of types historically known to express EGFR and/or HER2, who are amenable to docetaxel, preferably patients with breast, prostate, or non-small cell lung cancer. Patients must have failed prior standard therapies associated with clinical benefits, including survival benefits, if such therapies are available. If docetaxel administration is standard therapy associated with clinical benefits, patients are eligible
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 or 1
Patients must have resolution from prior chemo-, hormone-, immuno-, or radiotherapy related toxicities to CTC Grade <= 1or baseline for individual patient
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 weeks, no history of cerebral edema or bleeding in the past eight 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 > upper limit of normal (ULN)
Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) > 1.5 x ULN
Alkaline Phosphatase > 2.5 x ULN
Serum creatinine > 1.5 mg / dl (> 132 μmol / L, SI (Système Internationale) unit equivalent)
Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
Pregnancy or breast-feeding
Concurrent treatment with other investigational drugs, or chemotherapy, immunotherapy, radiotherapy or hormone therapy (excluding Luteinizing hormone-releasing hormone agonists, or other hormones taken for breast cancer, or bisphosphonates) or participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
Treatment with an EGFR- or HER2 inhibiting drug within the past four weeks before start of therapy or concomitantly with this study (8 weeks for trastuzumab)
Patients unable to comply with the protocol
Active alcohol or drug abuse
Hypersensitivity to docetaxel or any component or other drug formulated with polysorbate 80

The patient may be eligible for re-treatment after the previous course is finished. The patient will not be eligible if any of the following conditions are met:

If patients' latest X-ray, CT or MRI reveals progressive disease, or if clinical assessment reveals signs of disease progression
Cardiac left ventricular function CTC Grade ≥ 2 at any time during the previous course
Patients fulfilling any of the Exclusion Criteria listed before as determined before treatment Day 1 of any new course
Patient not recovered from any dose-limiting toxicity (DLT) 14 days after onset. Recovery is defined as a return to baseline level or CTC Grade 1, whichever is higher