Phase I Trial of BI 836845 for Various Solid Cancer

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01403974
First received: July 12, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) of a new drug BI 836845 which blocks the insulin-like growth factor (IGF) pathway believed to be involved in cancer growth. BI 836845 will be administered for the very first time into cancer patients.

The study will also look at the overall safety of the drug, and examine the drug levels in the body at specific timepoints during the trial (pharmacokinetic profile); the effect the drug may have on tumours will also be examined (pharmacodynamics).


Condition Intervention Phase
Neoplasms
Drug: BI 836845
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Patients With Advanced Solid Cancers With Repeated Administrations in Patients Showing Clinical Benefit

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Incidence and intensity of Adverse Event according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: up to 4 months after last administration of BI 836845 ] [ Designated as safety issue: No ]
  • Dose limiting adverse drug reaction [ Time Frame: up to 4 months after last administration of BI 836845 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Volume of distribution after intravenous infusion at steady state (Vss) [ Time Frame: up to 28 days after end of treatment visit ] [ Designated as safety issue: No ]
  • Maximum measured plasma concentration (Cmax) [ Time Frame: up to 28 days after end of treatment visit ] [ Designated as safety issue: No ]
  • Time from dosing to the maximum plasma concentration (tmax) [ Time Frame: up to 28 days after end of treatment visit ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve over the time interval of one week (AUC0-168) [ Time Frame: up to 28 days after end of treatment visit ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC0-infinity) [ Time Frame: up to 28 days after end of treatment visit ] [ Designated as safety issue: No ]
  • Terminal half-life (t1/2) [ Time Frame: up to 28 days after end of treatment visit ] [ Designated as safety issue: No ]
  • Mean residence time after intravenous infusion (MRT) [ Time Frame: up to 28 days after end of treatment visit ] [ Designated as safety issue: No ]
  • Total plasma clearance (CL) [ Time Frame: up to 28 days after end of treatment visit ] [ Designated as safety issue: No ]
  • Apparent volume of distribution during the terminal phase (Vz) [ Time Frame: up to 28 days after end of treatment visit ] [ Designated as safety issue: No ]
  • Disease control (composite of complete response, partial response, stable disease > 6 weeks) according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 [ Time Frame: every 6 weeks for 18 weeks then every 9 weeks until last administration of BI 836845 18 weeks ] [ Designated as safety issue: No ]
  • Complete response according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 [ Time Frame: every 6 weeks for 18 weeks then every 9 weeks until last administration of BI 836845 18 weeks ] [ Designated as safety issue: No ]
  • Partial response according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 [ Time Frame: every 6 weeks for 18 weeks then every 9 weeks until last administration of BI 836845 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monotherapy
BI 836845 dose escalation, infusion, once every week, monotherapy
Drug: BI 836845
Intravenous infusion once every week

  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 solid cancer, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment.
  • Patients should have evaluable disease, or at least one measurable lesion according to RECIST criteria version 1.1.
  • Age 18 years or older.
  • Life expectancy of at least 3 months in the opinion of the investigator.
  • Written informed consent that is consistent with ICH-GCP guidelines and local legislation.
  • Eastern Cooperative Oncology Group performance score 0, 1 or 2.
  • Absolute neutrophil count more than or equal to 1,500/µL.
  • Platelets more than or equal to 100,000/µL.
  • Total bilirubin less than or equal to 1.5x institution ULN.
  • AST and ALT less than or equal to 2.5x institution ULN (in case of hepatic primary cancer or known liver metastases: AST and ALT less than or equal to 5x ULN).
  • Creatinine less than or equal to 1.5 x institution ULN.
  • Haemoglobin more than or equal to 9g/dL.
  • Haemoglobin A1c less than 8% and fasting plasma glucose less than or equal to 160 mg/dL (8.9 mmol/L).

Exclusion criteria:

  • Active infectious disease considered by the investigator to be incompatible with the protocol.
  • Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
  • History of thrombosis within 1 year of study or if concurrent anticoagulation required, except low-dose warfarin.
  • Patients not recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, molecular targeted, or radiotherapies to at least CTCAE less than or equal to Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to first trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy.
  • Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least 4 weeks before starting trial medication, no history of cerebral oedema or bleeding in the past 4 weeks before starting trial medication and must be on a stable or reducing dose of dexamethasone. Anti-epileptic therapy will be allowed if the patient is stable on antiepileptic treatment for 4 weeks, or more, without adjustments before starting trial medication.
  • Patients who have been treated with any of the following within 4 weeks of starting trial medication: chemotherapy, immunotherapy, radiotherapy, molecular-targeted therapy, biological therapies (including trastuzumab), hormone therapy for breast cancer within 2 weeks of starting trial medication (excluding LHRH agonists in prostate cancer, or bisphosphonates), or treatment with other investigational drugs.
  • Participation in another clinical trial within the past 4 weeks before start of trial medication or concomitantly with this trial.
  • Patients unable to comply with the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403974

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Taiwan
1280.1.88603 Boehringer Ingelheim Investigational Site Recruiting
Taichung, Taiwan
1280.1.88602 Boehringer Ingelheim Investigational Site Recruiting
Tainan, Taiwan
1280.1.88601 Boehringer Ingelheim Investigational Site Recruiting
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01403974     History of Changes
Other Study ID Numbers: 1280.1
Study First Received: July 12, 2011
Last Updated: April 2, 2014
Health Authority: Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014