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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

Page last updated: August 20, 2015

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