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

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: NCT00831636
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : September 13, 2013
Information provided by (Responsible Party):
Clavis Pharma

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: CP-4055 Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Study Start Date : April 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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

Primary Outcome Measures :
  1. 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 ]
  2. Phase II: Determine the antitumour activity of CP-4055 [ Time Frame: August 2009/June 2010 ]

Secondary Outcome Measures :
  1. Determine pharmacokinetic (PK) parameters [ Time Frame: August 2009/June 2010 ]
  2. Explore the time to progression (TTP) [ Time Frame: August 2009/June 2010 ]
  3. Investigate the duration of tumour response [ Time Frame: August 2009/June 2010 ]
  4. Determine the nature and degree of toxicity of CP-4055 in this patient population [ Time Frame: August 2009/June 2010 ]

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:   Female
Accepts Healthy Volunteers:   No

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

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): NCT00831636

U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
Leuven, Belgium, B-3000
Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
Aviano (PN), Italy
Medical Oncology B, National Cancer Institute, Via Mariano Semmola
Naples, Italy, IT-80131
Department of Oncology, Catholic University of the Sacred Heart
Rome, Italy, 00168
Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina
Rome, Italy
Sponsors and Collaborators
Clavis Pharma
Principal Investigator: Sandro Pignata, MD Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy

Additional Information:
Responsible Party: Clavis Pharma Identifier: NCT00831636     History of Changes
Other Study ID Numbers: CP4055-204
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013

Keywords provided by Clavis Pharma:
Solid tumors
advanced ovarian cancer
stage III and IV ovarian cancer
advanced epithelian ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs