A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer

September 12, 2013 updated by: Clavis Pharma
This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase I

  • Three eligible patients will be enrolled at each dose level (DL), according to standard dose escalation decision rules
  • Patients will receive CP-4055 at increasing DLs until the maximum tolerated dose and the recommended dose (RD) have been established

Phase II

  • Step 1 (The patient inclusion may stop after this step):

    • Patients will be enrolled at the RD until there are maximum 16 evaluable patients at this DL

  • Step 2:

    • Depending on the response rate at step 1, up to 26 patients will be included and treated at step 2

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
  • Italy
      • Aviano (PN), Italy
        • Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
      • Naples, Italy, IT-80131
        • Medical Oncology B, National Cancer Institute, Via Mariano Semmola
      • Rome, Italy, 00168
        • Department of Oncology, Catholic University of the Sacred Heart
      • Rome, Italy
        • Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically or cytologically documented advanced epithelial ovarian cancer measurable with CT and/or MRI
  • Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT)
  • Evidence of platinum resistant or refractory disease
  • ECOG Performance Status 0 - 1
  • Life expectancy > 3 months
  • Signed informed consent (IC)
  • Women of child-bearing potential must have a negative serum or urine pregnancy test. Nursing patients are excluded.
  • Women of child-bearing potential must not become pregnant while participating in the study
  • Adequate haematological and biological functions

Exclusion Criteria:

  • Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
  • Known brain metastases
  • Another known active cancer within the last 5 years
  • Radiotherapy to more than 30 % of bone marrow
  • Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
  • Concomitant treatment with a non-permitted medication
  • A history of allergic reactions or sensitivity attributed to compounds of similar or biological composition to CP-4055, i.e., ara-C and/or egg
  • Any serious concomitant systemic disorders incompatible with the clinical study
  • Any significant CNS or psychiatric disorder(s) that would hamper the patient's compliance
  • Pregnancy or breastfeeding
  • Known positive status for HIV and/or hepatitis B or C
  • Drug and/or alcohol abuse
  • Any reason why, in the investigator's opinion, the patient should not participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label CP-4055
Phase I: Dose escalation Phase II: Fixed dose
Drug: CP-4055
D1-5 and D8(+2)-12(+2) q4w
Drug: CP-4055
IV administration day 1-5 and day 8-12 in a 4 week schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w
Time Frame: August 2009/June 2010
August 2009/June 2010
Phase II: Determine the antitumour activity of CP-4055
Time Frame: August 2009/June 2010
August 2009/June 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine pharmacokinetic (PK) parameters
Time Frame: August 2009/June 2010
August 2009/June 2010
Explore the time to progression (TTP)
Time Frame: August 2009/June 2010
August 2009/June 2010
Investigate the duration of tumour response
Time Frame: August 2009/June 2010
August 2009/June 2010
Determine the nature and degree of toxicity of CP-4055 in this patient population
Time Frame: August 2009/June 2010
August 2009/June 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clavis Pharma

Investigators

  • Principal Investigator: Sandro Pignata, MD, Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimate)

January 29, 2009

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP4055-204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on CP-4055

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe