Dose-Escalation Study of PHA-793887 in Patients With Advanced/Metastatic Solid Tumors

Advanced/Metastatic Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00996255
• Other study ID #: CDKC-887-001
• Secondary ID: EudraCT Number:
• Status: Terminated
• Phase: Phase 1
• First received: October 14, 2009
• Last updated: October 15, 2009
• Start date: November 2006
• Est. completion date: February 2008

Study information

• Verified date: October 2009
• Source: Nerviano Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Advanced/Metastatic Solid Tumors

Intervention

Drug:
• PHA-793887
Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.

Locations

Country	Name	City	State
France	Institut Gustave-Roussy	Villejuif Cedex
United Kingdom	St. James University Hospital	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Nerviano Medical Sciences

Countries where clinical trial is conducted

France,  United Kingdom, 

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
Secondary	Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment.		First cycle	No