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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01206816
First received: September 21, 2010
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: BI 6727 + BIBW 2992
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 in Combination With Oral BIBW 2992 in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992 [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tumour responses according to the response criteria in solid tumours (RECIST 1.1) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Incidence and intensity of drug-related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria v 3.0 [ Time Frame: up to 25 months ] [ Designated as safety issue: No ]
  • Incidence of Dose Limiting Toxicity (DLT) according to Common Terminology Criteria for Adverse Events (CTCAE) criteria v 3.0 [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: October 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: two experimental arms
patients receive increasing doses of BI 6727 in combination with increasing doses of BIBW 2992
Drug: BI 6727 + BIBW 2992
BI 6727 administered i.v. every 21 days + BIBW 2992 given orally once a day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206816

Locations
Belgium
1230.20.32001 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1230.20.32003 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1230.20.32002 Boehringer Ingelheim Investigational Site
Gent, Belgium
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01206816     History of Changes
Other Study ID Numbers: 1230.20, 2010-019437-97
Study First Received: September 21, 2010
Last Updated: October 31, 2013
Health Authority: Belgium: Federal Agency for Medicinal and Health Products

ClinicalTrials.gov processed this record on November 25, 2014