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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00996255
Recruitment Status : Terminated
First Posted : October 16, 2009
Last Update Posted : October 16, 2009
Information provided by:
Nerviano Medical Sciences

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: Dose-Escalation Drug: PHA-793887
Escalating doses of PHA-793887 administered weekly by IV infusion for 3 consecutive weeks in 4-week cycles.

Primary Outcome Measures :
  1. Determination of Dose Limiting Toxicities and Maximum Tolerated Dose [ Time Frame: First cycle ]

Secondary Outcome Measures :
  1. Assessment of Adverse Events (based on CTCAE version 3.0) [ Time Frame: All cycles ]
  2. Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters. [ Time Frame: First 2 cycles ]
  3. Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment. [ Time Frame: First cycle ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00996255

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Institut Gustave-Roussy
Villejuif Cedex, France, 94805
United Kingdom
St. James University Hospital
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Nerviano Medical Sciences
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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
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Responsible Party: Clinical Research Head, Nerviano Medical Sciences Identifier: NCT00996255    
Other Study ID Numbers: CDKC-887-001
EudraCT Number: 2006-002149-35
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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