Clinical trial NCT00831636: A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Official title: A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Keywords: CP-4055
Cancer
Metastatic
Solid tumors
advanced ovarian cancer
stage III and IV ovarian cancer
advanced epithelian ovarian cancer
Lead sponsor: Clavis Pharma
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: 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
timeFrame: August 2009/June 2010
measure: Phase II: Determine the antitumour activity of CP-4055
timeFrame: August 2009/June 2010
Secondary outcomes:
measure: Determine pharmacokinetic (PK) parameters
timeFrame: August 2009/June 2010
measure: Explore the time to progression (TTP)
timeFrame: August 2009/June 2010
measure: Investigate the duration of tumour response
timeFrame: August 2009/June 2010
measure: Determine the nature and degree of toxicity of CP-4055 in this patient population
timeFrame: August 2009/June 2010
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
city: Aviano (PN)
country: Italy
facility: Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
city: Naples
country: Italy
facility: Medical Oncology B, National Cancer Institute, Via Mariano Semmola
city: Rome
country: Italy
facility: Department of Oncology, Catholic University of the Sacred Heart
city: Rome
country: Italy
facility: Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina
Study officials:
affiliation: Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy
name: Sandro Pignata, MD
role: PRINCIPAL_INVESTIGATOR
References: