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

NCT ID: NCT02211859

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 2536

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

Group Type EXPERIMENTAL

BI 2536

Intervention Type DRUG

Interventions

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BI 2536

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1216.2

Identifier Type: -

Identifier Source: org_study_id