NCT00996255

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2006

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

1.3 years

First QC Date

October 14, 2009

Last Update Submit

October 15, 2009

Conditions

Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Determination of Dose Limiting Toxicities and Maximum Tolerated Dose

    First cycle

Secondary Outcomes (3)

  • Assessment of Adverse Events (based on CTCAE version 3.0)

    All cycles

  • Evaluation of pharmacokinetics: plasma concentrations at different times after dosing and related assessment of conventional pharmacokinetic parameters.

    First 2 cycles

  • Evaluation of pharmacodynamics: biomarkers modulation in skin and tumor samples of consenting patients at baseline and post-treatment.

    First cycle

Study Arms (1)

Dose-Escalation

EXPERIMENTAL
Drug: PHA-793887

Interventions

PHA-793887DRUG

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

Dose-Escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Gustave-Roussy

Villejuif, 94805, France

Location

St. James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

MeSH Terms

Interventions

N-(6,6-dimethyl-5-((1-methylpiperidin-4-yl)carbonyl)-1,4,5,6-tetrahydropyrrolo(3,4-c)pyrazol-3-yl)-3-methylbutanamide

Study Officials

  • Jean-Charles Soria, MD Professor

    Institut Gustave-Roussy, Villejuif Cedex, France

    PRINCIPAL INVESTIGATOR

  • Chris Twelves, MD Professor

    St James University Hospital, Leeds, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 16, 2009

Study Start

November 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

GB(1)FR(1)