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

NCT02211859 | Completed Phase 1

• 1 other identifier: 1216.2
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT)

  up to 3 weeks

Secondary Outcomes (15)

• Number of patients with drug-related adverse events

  up to 24 days after last drug administration

• Number of patients with abnormal laboratory findings

  up to 24 days after last drug administration

• Change in Eastern Cooperative Oncology Group (ECOG) performance score

  baseline, up to 24 days after last drug administration

• Number of patients with clinically significant changes in vital signs

  up to 24 days after last drug administration

• Number of patients with objective tumor response

  up to 24 days after last drug administration

Study Arms (1)

BI 2536

EXPERIMENTAL

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

Drug: BI 2536

Interventions

BI 2536 DRUG

BI 2536

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 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Neoplasms

Interventions

BI 2536

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• 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: December 1, 2007
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.