BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours

NCT02273388 | Completed Phase 1 Results

• 3 other identifiers: 1230.12005-002500-421230-0001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events. Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  MTD is defined as: the dose of BI 6727 which is one dose tier below that dose at which two or more out of a maximum of six patients experienced dose-limiting toxicity (DLT). At the maximum tolerated dose, no more than one patient out of six patients may experience DLT, i.e. MTD is defined as the highest dose studied for which the incidence of dose-limiting toxicity is no more than 17% (i.e. 1/6 patients) during the first course. DLT is defined as drug related common terminology criteria for adverse events (CTCAE) grade 3 or 4 non haematological toxicity (except emesis or diarrhoea responding to supportive treatment), or drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection, or CTCAE Grade 4 thrombocytopenia .

  21 days (first treatment course).

Secondary Outcomes (24)

• Number of Participants With Adverse Events (AEs)

  From first drug administration until last drug administration plus 21 days, up to 835 days.

• Number of Participants With Clinically Relevant Abnormalities

  From baseline to the last value on treatment, up to 814 days.

• Number of Participants With Change in Eastern Cooperative Oncology Group (ECOG) Patient Performance Score

  At baseline and at end of treatment (up to 814 days).

• Electrocardiogram (ECG) - QTcF Change From Baseline

  At baseline and 5 minutes before infusion end, 1 hour after end of infusion and at 4 and 12 hours after start of infusion, at course 1.

• Vital Signs - Blood Pressure

  At baseline.

Study Arms (12)

12 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

24 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

48 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

75 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

125 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

200 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

300 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

300 mg BI 6727 1h2h

EXPERIMENTAL

Infusion over 1 hour (1h) in course 1 and over 2 hours (2h) in course 2.

Drug: BI 6727

300 mg BI 6727 2h1h

EXPERIMENTAL

Infusion over 2 hours (2h) in course 1 and over 1 hours (1h) in course 2.

Drug: BI 6727

350 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

400 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

450 mg BI 6727

EXPERIMENTAL

Drug: BI 6727

Interventions

BI 6727 DRUG

BI 6727

Also known as: Volasertib

12 mg BI 6727; 125 mg BI 6727; 200 mg BI 6727; 24 mg BI 6727; 300 mg BI 6727; 300 mg BI 6727 1h2h; 300 mg BI 6727 2h1h; 350 mg BI 6727; 400 mg BI 6727; 450 mg BI 6727; 48 mg BI 6727; 75 mg BI 6727

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
• Age 18 years or older
• Written informed consent consistent with ICH-GCP and local legislation
• Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2
• Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies (except alopecia)
• The 18 additional patients recruited at the MTD must also meet the following criterion:
• Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI)

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 or known chronic Hepatitis B/Hepatitis C infection
• Clinical evidence of active brain or leptomeningeal disease during the past 12 months
• Second malignancy currently requiring active therapy
• Absolute neutrophil count less than 1500 / mm3
• Platelet count less than 100 000 / mm3
• Bilirubin greater than 1.5 mg / dl (\> 26 ¿mol / L, SI unit 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 ¿mol / L, SI unit equivalent)
• Known history of relevant QT-prolongation, e.g. long QT-syndrome
• 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)
• Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
• Patients unable to comply with the protocol

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1230.1.32002 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1230.1.32001 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

BI 6727

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 24, 2014
• Study Start: November 4, 2005
• Primary Completion: January 19, 2009
• Study Completion: April 6, 2021
• Last Updated: October 3, 2023
• Results First Posted: October 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)