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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumour

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determination of Dose Limiting Toxicities and Maximum Tolerated Dose

Outcome Time Frame:

First cycle

Safety Issue:

Yes

Principal Investigator

Daniel Von Hoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scottsdale Clinical Research Institute, Scottsdale AZ, USA

Authority:

United States: Food and Drug Administration

Study ID:

CDKO-125a-001

NCT ID:

NCT01300468

Start Date:

April 2006

Completion Date:

December 2009

Related Keywords:

  • Solid Tumour
  • advanced/metastatic solid tumors
  • Neoplasms

Name

Location

The Johns Hopkins University Baltimore, Maryland  21287
Scottsdale Clinical Research Institute Scottsdale, Arizona  85258