Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Activity of CH5132799 Administered Orally as a Monotherapy in Patients With Advanced Solid Tumors

Chugai Pharma Europe Ltd.1 site in 1 country38 target enrollmentAugust 2010

ConditionsSolid Tumors

InterventionsCH5132799

DrugsCH5132799

Overview

Phase: Phase 1
Intervention: CH5132799
Conditions: Solid Tumors
Sponsor: Chugai Pharma Europe Ltd.
Enrollment: 38
Locations: 1
Primary Endpoint: Preliminary anti-tumour activity
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, multi-center, dose-escalation Phase I study to evaluate safety, pharmacokinetics and activity of CH5132799 administered orally as a single agent in patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

December 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chugai Pharma Europe Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of signed written informed consent.
•Histologically or cytologically confirmed diagnosis of advanced solid tumor.
•Age ≥ 18 years.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
•Life expectancy of ≥ 12 weeks.
•Disease measurability:
•Patients must have a measurable - as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1 - and/or evaluable disease.
•Paraffin-embedded archival tumor tissue available. Fresh biopsies will be required if no paraffin embedded tumor tissues available.
•Adequate bone marrow function.
•Adequate cardiac function: Patient should have Left Ventricular Ejection Fraction (LVEF) of ≥ 50% as determined by echocardiography (ECHO) or Multi Gated Acquisition (MUGA) scans.

Exclusion Criteria

•History of allergic reactions attributed to components of the formulated product.
•Inability to swallow oral medications or impaired gastrointestinal absorption due to active inflammatory bowel disease.
•Known Central Nervous System (CNS) metastases or leptomeningeal metastases will be eligible only if it could be radiologically demonstrated that there is no CNS disease progression during the 3 months prior to the study
•Known active or uncontrolled pulmonary dysfunction.
•Uncontrolled hypertension
•Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy for bone pain), or immunotherapy within 28 days of first receipt of study drug (within 6 weeks for nitrosoureas and mitomycin C). Hormone therapy within 14 days of first receipt of study drug, with exception of prostate cancer if indicated.
•Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade ≤ 1 severity - National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0).
•Type 1 or 2 diabetes mellitus requiring regular medication and/or a fasting plasma glucose (FPG) ≥ 120 mg/dL (or 6.6 mmol/dL) at screening.
•Increased QTc interval (QTc \> 450 ms for male; \> 460 ms for female).
•History of heart failure, refractory hypokalemia to adequate supplementation, family history of long QT syndrome or other risk factors for "Torsades de Pointes", and/or the use of concomitant medications that prolong the QT/QTc interval.

Arms & Interventions

CH5132799

Intervention: CH5132799

Outcomes

Primary Outcomes

Preliminary anti-tumour activity

Time Frame: Upon completion of the study

Occurrence of dose limiting toxicities

Time Frame: Upon completion of the study

Secondary Outcomes

To determine the pharmacokinetics of CH5132799(Upon completion of the study)
To characterise the pharmacodynamic effect of CH5132799 in surrogate tissues(Upon completion of the study)