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

NCT01300468 | Completed Phase 1

• 1 other identifier: CDKO-125a-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumour

Keywords

advanced/metastatic solid tumors

Outcome Measures

Primary Outcomes (1)

• Determination of Dose Limiting Toxicities and Maximum Tolerated Dose

  First cycle

Secondary Outcomes (2)

• Assessment of Adverse Events (based on CTCAE version 3.0)

  All cycles

• Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters

  First 2 cycles

Study Arms (1)

Dose-escalation

EXPERIMENTAL

Drug: PHA-848125AC

Interventions

PHA-848125AC DRUG

Dose-escalation

Eligibility Criteria

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

You may qualify if:

• 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
• Use of effective contraceptive methods if men and women of child producing potential
• Capability to swallow capsules intact
• Grade \<=1 retinopathy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nerviano Medical Sciences: lead

Study Sites (2)

Scottsdale Clinical Research Institute

Scottsdale, Arizona, 85258, United States

Location

The Johns Hopkins University

Baltiomore, Maryland, 21212, United States

Location

MeSH Terms

Interventions

N,1,4,4-tetramethyl-8-((4-(4-methylpiperazin-1-yl)phenyl)amino)-4,5-dihydro-1H-pyrazolo(4,3-h)quinazoline-3-carboxamide

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 21, 2011
• Study Start: April 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 21, 2011

Record last verified: 2011-02

Locations

US (2)