MPACT EXTENSION STUDY: MULTICENTER, SURVIVAL DATA COLLECTION IN SUBJECTS PREVIOUSLY ENROLLED IN PROTOCOL CA046

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003866-15-AT

Enrollment

Registered

2013-12-04

Start date

2014-01-24

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Adenocarcinoma of the Pancreas MedDRA version: 16.1 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic System Organ Class: 100000004864

Interventions

Trade Name: Abraxane Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Trade Name: GEMZAR 1000 mg powder for solution for infusion Produc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Must have been enrolled in the CA046 study. 2. Must have been living at the time of the last survival follow-up (approximate timeframe – end of March, 2013) 3. Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (ie, next of kin, legal representative) will be obtained prior to collection of data). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 41 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29

Exclusion criteria

Exclusion criteria: 4. Consent refused for any reason.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to collect survival/vital status of CA046 subjects who were known to be alive at the last report of vital status for CA046;Secondary Objective: The secondary objectives of the study are to collect date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046.;Primary end point(s): Vital status / overall survival for CA046 subjects who were known to be alive at the last report of vital status for CA046;Timepoint(s) of evaluation of this end point: approximate timeframe – end of March, 2013.	—

Measure

Time frame

Main Objective: The primary objective of the study is to collect survival/vital status of CA046 subjects who were known to be alive at the last report of vital status for CA046;Secondary Objective: The secondary objectives of the study are to collect date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046.;Primary end point(s): Vital status / overall survival for CA046 subjects who were known to be alive at the last report of vital status for CA046;Timepoint(s) of evaluation of this end point: approximate timeframe – end of March, 2013.

—

Secondary

Measure	Time frame
Secondary end point(s): Date of disease progression and subsequent anticancer therapy for pancreatic adenocarcinoma other than that already recorded for subject while enrolled in CA046.;Timepoint(s) of evaluation of this end point: Enrollment in CA046	—

Countries

Australia, Austria, Canada, France, Germany, Italy, Spain, Ukraine, United States

Contacts

Public ContactClinicalTrialDisclosure

Celgene Corporation

ClinicalTrialDisclosure@celgene.com+1888-260-1599

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026