An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 (Volasertib)in Combination With Oral BIBW 2992 (Afatinib) in Patients With Advanced Solid Tumours

NCT ID: NCT01206816

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-04
• Study Completion Date: 2012-11-15

Brief Summary

The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992, in patients with advanced or metastatic solid tumours. Dosages of both BI 6727 and BIBW 2992 will be varied to establish the MTD of the combination. Two combination treatment schedules will be tested, the MTD of each combination will be determined.

Secondary objectives are the exploration of pharmacokinetics, overall safety and preliminary efficacy.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

two experimental arms

patients receive increasing doses of BI 6727 in combination with increasing doses of BIBW 2992

Group Type: EXPERIMENTAL

BI 6727 + BIBW 2992

Intervention Type: DRUG

BI 6727 administered i.v. every 21 days + BIBW 2992 given orally once a day

Interventions

BI 6727 + BIBW 2992

BI 6727 administered i.v. every 21 days + BIBW 2992 given orally once a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and/or metastatic, relapsed or refractory solid tumours not amenable to standard therapy and for whom no therapy of proven efficacy exists
• Eastern Cooperative Oncology Group performance score 0 - 2
• Recovery from clinically significant toxicities from previous systemic anti-cancer therapies or radiotherapy

Exclusion Criteria

• Serious illness, concomitant non-oncological disease or mental problem considered by the investigator to be incompatible with participation to the trial
• Known hypersensitivity to the trial drugs or their excipients
• Treatment with any other investigational drug or active participation in any other interventional trial within 28 days before first administration of trial drug(s) or concomitantly with this trial
• Major surgery or radiotherapy within 28 days before start of therapy or concomitantly with this trial
• Systemic anti-cancer therapy within 28 days before start of therapy or concomitantly with this trial
• Requirements for treatment with any of the prohibited concomitant medications
• Active infectious disease or known HIV I/II infection
• Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
• Active brain metastases
• History or presence of cardiovascular abnormalities deemed clinically relevant by the investigator
• Cardial left ventricular function with resting ejection fraction < 50%
• Inadequate hepatic, renal and haematologic organ function
• QT prolongation deemed clinically relevant by the investigator
• Active alcohol or drug abuse
• Women of childbearing potential and men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial and 28 days thereafter
• Pregnancy or breast-feeding
• Patients unable to comply with the protocol
• Patients with known pre-existing interstitial lung disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1230.20.32001 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1230.20.32003 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

1230.20.32002 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Countries

Belgium

References

Machiels JP, Peeters M, Herremans C, Surmont V, Specenier P, De Smet M, Pilz K, Strelkowa N, Liu D, Rottey S. A phase I study of volasertib combined with afatinib, in advanced solid tumors. Cancer Chemother Pharmacol. 2015 Oct;76(4):843-51. doi: 10.1007/s00280-015-2860-2. Epub 2015 Sep 8.

Reference Type: DERIVED

PMID: 26349473 (View on PubMed)

Other Identifiers

2010-019437-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1230.20

Identifier Type: -

Identifier Source: org_study_id