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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clavis Pharma
ClinicalTrials.gov Identifier:
NCT00831636
First received: January 28, 2009
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: CP-4055
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Clavis Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Phase II: Determine the antitumour activity of CP-4055 [ Time Frame: August 2009/June 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine pharmacokinetic (PK) parameters [ Time Frame: August 2009/June 2010 ] [ Designated as safety issue: No ]
  • Explore the time to progression (TTP) [ Time Frame: August 2009/June 2010 ] [ Designated as safety issue: No ]
  • Investigate the duration of tumour response [ Time Frame: August 2009/June 2010 ] [ Designated as safety issue: No ]
  • Determine the nature and degree of toxicity of CP-4055 in this patient population [ Time Frame: August 2009/June 2010 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: April 2008
Study Completion Date: April 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831636

Locations
Belgium
U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
Leuven, Belgium, B-3000
Italy
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
Investigators
Principal Investigator: Sandro Pignata, MD Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy
  More Information

Additional Information:
No publications provided

Responsible Party: Clavis Pharma
ClinicalTrials.gov Identifier: NCT00831636     History of Changes
Other Study ID Numbers: CP4055-204
Study First Received: January 28, 2009
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Clavis Pharma:
CP-4055
Cancer
Metastatic
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
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 15, 2014