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

Solid Tumour Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300468
• Other study ID #: CDKO-125a-001
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2011
• Last updated: February 18, 2011
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: February 2011
• Source: Nerviano Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumour

Intervention

Drug:
• PHA-848125AC

Locations

Country	Name	City	State
United States	The Johns Hopkins University	Baltiomore	Maryland
United States	Scottsdale Clinical Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Nerviano Medical Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Dose Limiting Toxicities and Maximum Tolerated Dose		First cycle	Yes
Secondary	Assessment of Adverse Events (based on CTCAE version 3.0)		All cycles	Yes
Secondary	Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters		First 2 cycles	No