BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasms
Intervention: BI 860585 (Drug); exemestane (Drug); BI 860585 (Drug); BI 860585 (Drug); paclitaxel (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Overall contact: Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
Summary
The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI
860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs,
patients are entered sequentially into escalating dose cohorts. Secondary objectives are
objective response and disease control according to RECIST criteria version 1. 1
Clinical Details
Official title: An Open Label Phase I Dose Finding Study of BI 860585 Administered Orally in a Continuous Dosing Schedule as Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumours
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum tolerated dose in each treatment arm (based on number of dose limiting toxicities (DLTs) in first course of each treatment arm.Number of DLTs in first course of each treatment arm.
Secondary outcome: AUC0-infinity of BI 860585 administered as single agent and with combination agents.t1/2(ss) of BI 860585 administered as single agent and with combination agents. tmax(ss) of BI 860585 administered as single agent and with combination agents. Objective response rate (complete response/CR, partial response/PR per RECIST criteria version 1.1). Disease control rate/clinical benefit rate (complete response/CR, partial response/PR, stable disease/SD per RECIST criteria version 1.1). Duration of objective response (CR/PR), defined as time from first objective response to the time to progression or death. Duration of clinical benefit (CR/PR/SD), defined as time from first clinical benefit to progression or death. AUC0-24(ss) of BI 860585 administered as single agent and with combination agents. Cmax(ss) of BI 860585 administered as single agent and with combination agents.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Patients with histologically or cytologically confirmed diagnosis of advanced,
measurable or evaluable, non-resectable and/or metastatic solid tumours, which has
shown to be progressive;
- Patients who have received previous standard of care therapy for their disease and
have progressed;
- 18 years or older;
- Life expectancy >= 3 months;
- Written informed consent in accordance with International Conference on
Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation;
- Eastern Cooperative Oncology Group (ECOG), performance score 0-2.
Additional inclusion criteria for the combination arms:
- Patients must have confirmed progressive disease within the last 6 months, (in case
of measurable disease, progression should be confirmed according to Response
Evaluation Criteria in Solid Tumours (RECIST) criteria version 1. 1;
- Patients carrying a tumour for whom treatment with either exemestane or paclitaxel
would be considered appropriate;
Exclusion criteria:
- Serious concomitant non-oncological disease/illness considered by the investigator to
be incompatible with the protocol;
- Patients with untreated or symptomatic brain metastases;
- Second malignancies requiring active therapy;
- Clinical Congestive Heart Failure (CHF) Grade III-IV;
- Myocardial infarction within the last 6 months prior to inclusion, or symptomatic
coronary artery disease;
- Adequate bone marrow, liver and renal function;
- Patients with HIV/hepatitis/active infectious disease considered by the investigator
to be incompatible with the protocol;
- Patients unable to take oral medication;
- Chronic diarrhoea or other gastrointestinal disorders;
- Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four
weeks of the first treatment with the study medication (or within one week for
noncytotoxic drugs);
- Recovery from previous surgery and anticancer medical treatments;
- Hypersensitivity to combination drugs or excipients;
- Patients with a history of uncontrolled diabetes mellitus.
Locations and Contacts
Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
1325.1.32001 Boehringer Ingelheim Investigational Site, Bruxelles, Belgium; Recruiting
1325.1.32002 Boehringer Ingelheim Investigational Site, Gent, Belgium; Recruiting
1325.1.39001 Boehringer Ingelheim Investigational Site, Milano, Italy; Recruiting
1325.1.39002 Boehringer Ingelheim Investigational Site, Parma, Italy; Recruiting
Additional Information
Starting date: September 2013
Last updated: July 17, 2015
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