BI 2536 BS in Patients With Advanced Solid Tumours and Repeated Administration in Patients With Clinical Benefit

NCT02211872 | Completed Phase 1

• 1 other identifier: 1216.1
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI 2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of safety, efficacy, and pharmacokinetics of BI 2536 BS

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) for a single dose of BI 2536 BS

  Up to 16 weeks

• MTD for single doses of BI 2536 BS on 3 consecutive days

  Up to 16 weeks

Secondary Outcomes (15)

• Assessment of objective treatment response by tumour measurements

  Up to 1 year

• Number of patients with adverse events

  Up to 1 year

• Maximum concentration of BI 2536 BS analyte in plasma (Cmax)

  Pre-dose, up to 216 hours after drug administration

• Time from dosing to maximum concentration of BI 2536 BS in plasma (tmax)

  Pre-dose, up to 216 hours after drug administration

• Area under the concentration-time curve of BI 2536 BS in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Pre-dose, up to 216 hours after drug administration

Study Arms (2)

Treatment A

EXPERIMENTAL

BI 2536 BS single rising dose

Drug: BI 2536 BS, intravenous

Treatment B

EXPERIMENTAL

BI 2536 BS multiple rising doses on three consecutive days (d1-3 schedule)

Drug: BI 2536 BS, intravenous

Interventions

BI 2536 BS, intravenous DRUG

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who had failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment
• Evaluable tumour deposits
• Age of 18 years or older
• Life expectancy of at least 6 months
• Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
• Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ≤ 2
• And full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

You may not qualify if:

• Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial 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, international system of units (SI) equivalent)
• 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, SI unit equivalent)
• Sexually active women and men who are 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)
• Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial
• Patients unable to comply with the trial protocol
• Or active alcohol or drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: August 1, 2004
• Primary Completion: March 1, 2007
• Last Updated: August 8, 2014

Record last verified: 2014-08