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

This study has been terminated.
Sponsor:
Information provided by:
Nerviano Medical Sciences
ClinicalTrials.gov Identifier:
NCT00996255
First received: October 14, 2009
Last updated: October 15, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Advanced/Metastatic Solid Tumors
Drug: PHA-793887
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Nerviano Medical Sciences:

Primary Outcome Measures:
  • Determination of Dose Limiting Toxicities and Maximum Tolerated Dose [ Time Frame: First cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of Adverse Events (based on CTCAE version 3.0) [ Time Frame: All cycles ] [ Designated as safety issue: Yes ]
  • Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters. [ Time Frame: First 2 cycles ] [ Designated as safety issue: No ]
  • Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment. [ Time Frame: First cycle ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: November 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose-Escalation Drug: PHA-793887
Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996255

Locations
France
Institut Gustave-Roussy
Villejuif Cedex, France, 94805
United Kingdom
St. James University Hospital
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Nerviano Medical Sciences
Investigators
Principal Investigator: Jean-Charles Soria, MD Professor Institut Gustave-Roussy, Villejuif Cedex, France
Principal Investigator: Chris Twelves, MD Professor St James University Hospital, Leeds, UK
  More Information

No publications provided

Responsible Party: Clinical Research Head, Nerviano Medical Sciences
ClinicalTrials.gov Identifier: NCT00996255     History of Changes
Other Study ID Numbers: CDKC-887-001, EudraCT Number: 2006-002149-35
Study First Received: October 14, 2009
Last Updated: October 15, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014