Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: BI 2536

Study type: Interventional

Funder types: Industry

Identifiers

NCT02211859

1216.2

Details and patient eligibility

About

Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
• Evaluable tumour deposits
• Age 18 years or older
• Life expectancy of at least six months
• Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
• Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
• Full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

Exclusion criteria

• Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
• Pregnancy or breastfeeding
• Active infectious disease
• Known brain metastases
• Second malignancy requiring therapy
• Absolute neutrophil count less than 1500/mm3
• Platelet count less than 100 000/mm3
• Bilirubin greater than 1.5 mg/dl (> 26 μmol/L)
• Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 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)
• Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
• Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

BI 2536

Experimental group

Description:

single escalating dose, followed by repeated administration in patients with clinical benefit

Treatment:

Drug: BI 2536