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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014