Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors

NCT01022853 | Completed Phase 1 Results

• 2 other identifiers: 1230.72008-008304-41
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in patients with advanced or metastatic solid tumours.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD).

  DLT was defined as: 1. Drug-related CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or 2. Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or 3. CTCAE grade 4 thrombocytopenia

  28 days

• Maximum Tolerated Dose (MTD) of Volasertib in Combination With Nintedanib

  The MTD was determined using a 3+3 design with de-escalation. The MTD was defined as the highest dose level at which maximal 1 out of 6 patients experienced DLT in the first course of the escalation nd de-escalation phase. However, all DLT's occurring in the trial were considered for selection of the recommended dose for further development.

  28 days

Secondary Outcomes (13)

• Number of Participants With Drug Related Adverse Events

  From first study drug administration until 28 days after the last administration of any study medication, up to 485 days

• Number of Participants With Dose Limiting Toxicities

  From first study drug administration until 28 days after the last administration of any study medication, up to 485 days

• Cmax of Volasertib

  0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion

• CL of Volasertib

  0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion

• Vss of Volasertib

  0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion

Study Arms (1)

BIBF 1120 and BI 6727

EXPERIMENTAL

Finding Maximum Tolerated Dose of BI 6727 in combination with BIBF 1120

Drug: BI 6727; Drug: BIBF 1120

Interventions

BI 6727 DRUG

intravenous each 21 days

BIBF 1120 and BI 6727

BIBF 1120 DRUG

oral continuously

BIBF 1120 and 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, and for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
• Age \> or = 18 years
• European Cooperative Oncology Group performance status \< or = 2
• Written informed consent in accordance with International Conference on Harmonization -Good Clinical Practice (ICH-GCP) and local legislation
• Recovery from Common Terminology Criteria for Adverse Events grade 2-4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapy (except alopecia)

You may not qualify if:

• Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial
• Known hypersensitivity to the trial drugs or their excipients
• Treatment with any other investigational drug or participation in any other interventional trial within 28 days before first administration of trial drug (BIBF 1120) or concomitantly with this trial
• Systemic anti-cancer therapy or radiotherapy within 28 days before start of therapy or concomitantly with this trial. The restriction does not apply to steroids and bisphosphonates
• Active infectious disease infection or HIV I/II
• Other malignancy currently requiring another anti-cancer therapy
• Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
• Known inherited predisposition to bleeding or thrombosis
• Radiographic evidence of cavitary or necrotic tumours
• History of clinically significant haemoptysis within the past 3 months
• Centrally located tumours with radiographic evidence (Computed Tomography or Magnetic Resonance Imaging) of local invasion of major blood vessels
• Absolute Neutrophil Count (ANC) less than 1.5 x 1000000000/L
• Platelets Count (PLT) less than 100 x 1000000000/L
• Total bilirubin \> upper limit of normal (ULN)
• Alaninaminotransferase (ALT) and/or Aspartateaminotransferase (AST) \>= 1.5 x ULN (in case of liver metastases: ALT and AST \>= 2.5 x ULN)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1230.7.39002 Boehringer Ingelheim Investigational Site

Ancona, Italy

Location

1230.7.39001 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

MeSH Terms

Conditions

Neoplasms

Interventions

BI 6727; nintedanib

Results Point of Contact

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

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2009
• First Posted: December 1, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 30, 2018
• Results First Posted: July 30, 2018

Record last verified: 2017-10

Locations

IT (2)