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

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumour Drug: PHA-848125AC Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: Dose-escalation Drug: PHA-848125AC

Primary Outcome Measures :
  1. Determination of Dose Limiting Toxicities and Maximum Tolerated Dose [ Time Frame: First cycle ]

Secondary Outcome Measures :
  1. Assessment of Adverse Events (based on CTCAE version 3.0) [ Time Frame: All cycles ]
  2. Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters [ Time Frame: First 2 cycles ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01300468

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
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

Responsible Party: Clinical Research Head, Nerviano Medical Sciences Identifier: NCT01300468     History of Changes
Other Study ID Numbers: CDKO-125a-001
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: February 2011

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