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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01300468
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : February 21, 2011
Information provided by:
Nerviano Medical Sciences

February 17, 2011
February 21, 2011
February 21, 2011
April 2006
May 2009   (Final data collection date for primary outcome measure)
Determination of Dose Limiting Toxicities and Maximum Tolerated Dose [ Time Frame: First cycle ]
Same as current
No Changes Posted
  • Assessment of Adverse Events (based on CTCAE version 3.0) [ Time Frame: All cycles ]
  • Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters [ Time Frame: First 2 cycles ]
Same as current
Not Provided
Not Provided
Study of PHA-848125AC in Adult Patients With Advanced/Metastatic Solid Tumors
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
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumour
Drug: PHA-848125AC
Experimental: Dose-escalation
Intervention: Drug: PHA-848125AC
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2009
May 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Clinical Research Head, Nerviano Medical Sciences
Nerviano Medical Sciences
Not Provided
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
Nerviano Medical Sciences
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP