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

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:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

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:

Clavis Pharma Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Kjell Hernes, Clavis Pharma ASA
ClinicalTrials.gov Identifier:	NCT00831636 History of Changes
Other Study ID Numbers:	CP4055-204
Study First Received:	January 28, 2009
Last Updated:	June 7, 2011
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 May 23, 2013