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

Sponsor

Clavis Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00831636

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

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 :

Apr 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

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

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

Outcome Measures

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 [August 2009/June 2010]
Phase II: Determine the antitumour activity of CP-4055 [August 2009/June 2010]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

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