Study of PHA-848125AC in Adult Patients With Advanced/Metastatic Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Nerviano Medical Sciences
ClinicalTrials.gov Identifier:
NCT01300468
First received: February 17, 2011
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

The purpose of this open-label, multi center, Phase I study was to determine the safety profile of the oral compound PHA-848125AC administered according to two different schedules of administrations to advanced/metastatic solid tumor patients. Objectives of the study were to determine the maximum tolerated dose and the dose that can be recommended for Phase II investigations.


Condition Intervention Phase
Solid Tumour
Drug: PHA-848125AC
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral PHA-848125AC Given Daily For 7 Consecutive Days Every 2 Weeks or for 4 Consecutive Days A Week for 3 Consecutive Weeks Every 4 Weeks to Adult Patients With Advanced/Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Nerviano Medical Sciences:

Primary Outcome Measures:
  • Determination of Dose Limiting Toxicities and Maximum Tolerated Dose [ Time Frame: First cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of Adverse Events (based on CTCAE version 3.0) [ Time Frame: All cycles ] [ Designated as safety issue: Yes ]
  • Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters [ Time Frame: First 2 cycles ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose-escalation Drug: PHA-848125AC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed, written IRB-approved Informed Consent
  • Histologically or cytologically confirmed relapsed or refractory solid tumors for which no standard therapy exists
  • ECOG (WHO) performance status 0-1
  • Life expectancy of at least 3 months
  • Age >=18 years
  • A negative pregnancy test (if female in reproductive years)
  • Acceptable liver and renal function
  • Acceptable hematologic status
  • 10. Previous cancer therapy is allowed with the exclusion of experimental CDK2 inhibitors. Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy must be completed within one month prior to study entry
  • Use of effective contraceptive methods if men and women of child producing potential
  • Capability to swallow capsules intact
  • Grade <=1 retinopathy

Exclusion Criteria:

  • In the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
  • Known brain metastases
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Pregnant or breast feeding women
  • Unwillingness or inability to comply with procedures required in this protocol
  • Known infection with HIV, active hepatitis B or hepatitis C
  • Diabetes mellitus uncontrolled, or with clinical evidence of diabetic retinopathy, severe peripheral vascular disease or diabetic ulcers
  • Current enrollment in another clinical trial
  • Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation (lactose intolerance)
  • Previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease, multiple sclerosis, stroke and cerebellar injury
  • Gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption
  • Chronic/intensive use of antacid or H2 receptor antagonists
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300468

Locations
United States, Arizona
Scottsdale Clinical Research Institute
Scottsdale, Arizona, United States, 85258
United States, Maryland
The Johns Hopkins University
Baltiomore, Maryland, United States, 21212
Sponsors and Collaborators
Nerviano Medical Sciences
Investigators
Principal Investigator: Daniel Von Hoff, MD Scottsdale Clinical Research Institute, Scottsdale AZ, USA
Principal Investigator: Manuel Hidalgo, MD The Johns Hopkins University, Baltimore MD, USA
Principal Investigator: Daniel Laheru, MD The Johns Hopkins University, Baltimore MD, USA
  More Information

No publications provided

Responsible Party: Clinical Research Head, Nerviano Medical Sciences
ClinicalTrials.gov Identifier: NCT01300468     History of Changes
Other Study ID Numbers: CDKO-125a-001
Study First Received: February 17, 2011
Last Updated: February 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Nerviano Medical Sciences:
advanced/metastatic solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 01, 2014