A Study of CP-4126 in Patients With Advanced Pancreatic C... | NCT00913198

Studies
A Study of CP-4126 in Patients With Advanced Pancreatic Cancer

NCT00913198

Sponsor

Clavis Pharma

Status

Completed

Last Update Posted

Feb 10, 2012Estimated

Enrollment

21Actual

Phase

Phase 2

Conditions

Advanced Adenocarcinoma of Pancreas

Interventions

IV CP-4126

Countries

Belgium
Norway

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

Feb 2012

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 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jun 3, 2009

First Submission Date that Met QC Criteria

Jun 3, 2009

First Posted Date

Jun 4, 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

Feb 9, 2012

Last Update Posted Date

Feb 10, 2012Estimated

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

Label	Type	Description	Intervention Names
IV CP-4126	Experimental		Drug: IV CP-4126

Name	Type	Description	Arm Group Labels	Other Names
IV CP-4126	Drug	1250 mg/m2/d, IV (in the vein) on day 1, 8 and 15 of each 4 week cycle. Number of Cycles: until progression or unacceptable toxicity develops.	IV CP-4126

Measure	Description	Time Frame
Biological activity of CP-4126 in patients with advanced pancreatic cancer.		Every second cycle

Measure	Description	Time Frame
Overall survival, Objective response rate.		Every second cycle - study length

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological or cytological confirmed advanced pancreatic cancer*
Not eligible for curative resection
Performance Status (ECOG) 0-2
Estimated life expectancy of at least 12 weeks
Age ≥ 18 years
Adequate haematological and biological functions:
- Neutrophils ≥ 1.5 x 109/L
- Platelets > 100.0 x 109/L
- Hb ≥ 10 g/dL
- AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases
- AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN
- Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN
- Serum creatinine ≤ 1.5 times institutional ULN
Signed informed consent

Exclusion Criteria:

Prior chemotherapy for metastatic disease
Symptomatic brain metastases
Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
History of allergic reactions to gemcitabine or egg
Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
Pregnant or breastfeeding women
Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment
Known positive status for HIV
Any reason why, in the investigator's opinion, the patient should not participate in the study.
Drug or alcohol abuse
Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed

Accepts Healthy Volunteers

Sex

All

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

Facility	Status	City	State	ZIP	Country	Contacts
Clinique d'Oncologie Médicale, Institut Jules Bordet		Brussels		1000	Belgium
Oslo University Hospital, The Norwegian Radium Hospital,