BI 2536 BS in Patients With Advanced Solid Tumours and Re... | NCT02211872

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

NCT02211872

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Aug 8, 2014Estimated

Enrollment

63Actual

Phase

Phase 1

Conditions

Neoplasms

Interventions

BI 2536 BS, intravenous

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Mar 2007Actual

Completion Date

Not provided

First Submitted Date

Aug 7, 2014

First Submission Date that Met QC Criteria

Aug 7, 2014

First Posted Date

Aug 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2014

Last Update Posted Date

Aug 8, 2014Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BI 2536 BS, intravenous	Drug		Treatment A Treatment B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Assessment of objective treatment response by tumour measurements	Evaluated according to the response evaluation criteria in solid tumors (RECIST)	Up to 1 year
Number of patients with adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided