Study of CH5132799 Administered Orally in Patients With Advanced Solid Tumors

NCT01222546 | Completed Phase 1

• 1 other identifier: PA-001EU
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Occurrence of dose limiting toxicities

  Upon completion of the study

• Preliminary anti-tumour activity

  Upon completion of the study

Secondary Outcomes (2)

• 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

Study Arms (1)

CH5132799

EXPERIMENTAL

Drug: CH5132799

Interventions

CH5132799 DRUG

CH5132799

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2.
• 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.
• Adequate liver function.
• Adequate renal function.
• Adequate adrenal function assessed by baseline cortisol of \> 200 nmol/L
• Ability to comply with protocol requirements.
• Female patients must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Male patients who have been sterilized must agree to use a barrier method of contraception. Male subjects must also commit to use a barrier method of contraception until at least 3 months after the end of study treatment.

You may not qualify if:

• 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.
• Prior corticosteroid therapy within 14 days of first receipt of study drug.
• Treatment with any investigational agent within 28 days of first receipt of study drug.
• Acute or chronic infection. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, contraindicates the use of an investigational drug, or will impose excessive risk to the patient.
• Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
• History of clinically significant bowel disease including abdominal fistula, gastro-intestinal perforation, and diverticulitis.

Sponsors & Collaborators

• Chugai Pharma Europe Ltd.: lead

Study Sites (1)

Investigator Sites

London, Leeds, United Kingdom

Location

MeSH Terms

Interventions

CH 5132799

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

GB (1)