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A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced/Metastatic Solid Tumors

Thank you

Trial Information

A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors


Inclusion Criteria:



- Advanced/metastatic solid tumors for which no standard therapy exists

- ECOG (WHO) performance status 0-1

- Life expectancy of at least 3 months

- Age ≥ 18 years

- Adequate liver, pancreas and renal function

- Acceptable hematologic status

- Acute toxic effects from prior therapy must be resolved to NCI CTCAE Grade ≤ 1

- Treatment with surgery, chemotherapy, or investigational therapy must be completed at
least one month prior to treatment initiation (6 weeks for nitrosoureas or Mitomycin
C and liposomal doxorubicin)

- Prior radiation therapy allowed in no more than 25% of bone marrow reserve

- Men and women of child-producing potential must agree upon the use of effective
contraceptive methods

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

- Known infection with HIV, active hepatitis B or hepatitis C

- Patients who have exhibited allergic reactions to a similar structural compound,
biological agent, or formulation

- History of pancreatitis or disorders making the patient at risk of pancreatitis

- Previous history or current presence of neurological disorders

- Patients with pre-existing symptoms of peripheral neuropathy not related to prior
anticancer therapy(ies)

- Concomitant treatment that may be associated with peripheral neuropathy

- Other severe concurrent conditions that could compromise protocol objectives.

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

Jean-Charles Soria, MD Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Gustave-Roussy, Villejuif Cedex, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CDKC-887-001

NCT ID:

NCT00996255

Start Date:

November 2006

Completion Date:

February 2008

Related Keywords:

  • Advanced/Metastatic Solid Tumors
  • Neoplasms

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