A Phase I/II Study of CP-4055 in Patients With Platinum R... | NCT00831636

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

NCT00831636

Sponsor

Clavis Pharma

Status

Completed

Last Update Posted

Sep 13, 2013Estimated

Enrollment

28Actual

Phase

Phase 1Phase 2

Conditions

Ovarian Cancer

Interventions

CP-4055
CP-4055

Countries

Belgium
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jan 28, 2009

First Submission Date that Met QC Criteria

Jan 28, 2009

First Posted Date

Jan 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2013

Last Update Posted Date

Sep 13, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Label	Type	Description	Intervention Names
Open label CP-4055	Experimental	Phase I: Dose escalation Phase II: Fixed dose	Drug: CP-4055

Name	Type	Description	Arm Group Labels	Other Names
CP-4055	Drug	D1-5 and D8(+2)-12(+2) q4w	Open label CP-4055
CP-4055

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Determine pharmacokinetic (PK) parameters		August 2009/June 2010
Explore the time to progression (TTP)		August 2009/June 2010
Investigate the duration of tumour response

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandro Pignata, MD	Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49		Leuven		B-3000	Belgium
Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico

ID	Term
D010051	Ovarian Neoplasms
D009369	Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases