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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831636
• Other study ID #: CP4055-204
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 28, 2009
• Last updated: September 12, 2013
• Start date: April 2008
• Est. completion date: April 2010

Study information

• Verified date: September 2013
• Source: Clavis Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: The Italian Medicines AgencyBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• CP-4055
D1-5 and D8(+2)-12(+2) q4w
• CP-4055
IV administration day 1-5 and day 8-12 in a 4 week schedule

Locations

Country	Name	City	State
Belgium	U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49	Leuven
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	Department of Oncology, Catholic University of the Sacred Heart	Rome
Italy	Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Clavis Pharma

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		August 2009/June 2010	No
Primary	Phase II: Determine the antitumour activity of CP-4055		August 2009/June 2010	No
Secondary	Determine pharmacokinetic (PK) parameters		August 2009/June 2010	No
Secondary	Explore the time to progression (TTP)		August 2009/June 2010	No
Secondary	Investigate the duration of tumour response		August 2009/June 2010	No
Secondary	Determine the nature and degree of toxicity of CP-4055 in this patient population		August 2009/June 2010	No

External Links

•   Clavis Pharma Home Page