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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01617629




Registration number
NCT01617629
Ethics application status
Date submitted
8/06/2012
Date registered
12/06/2012
Date last updated
8/12/2017

Titles & IDs
Public title
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
Scientific title
An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study
Secondary ID [1] 0 0
CAN-003X
Universal Trial Number (UTN)
Trial acronym
CAN-003X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MUC1 Dendritic Cell Vaccine (Cvac)

Experimental: Cvac Treatment Group - Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.


Treatment: Other: MUC1 Dendritic Cell Vaccine (Cvac)
The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).

Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Timepoint [1] 0 0
First dose of study vaccine to 30 days past last dose (Approximately 1 Year)

Eligibility
Key inclusion criteria
* Female patients = 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in CAN-003
* Able and willing to undergo mononuclear cell (MNC) collection (if required for patients who do not have available Cvac doses)
* Were enrolled in CAN-003 and met protocol criteria for progressive disease
* Wish to remain in the study and, in the investigator's judgment, the potential benefit of Cvac treatment outweighs the risk
* Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion
* Able to provide written informed consent
* White blood cell count (WBC) = 3.0 K/µL, absolute neutrophil count = 1.5 K/µL, hemoglobin = 9.0 g/dL, and platelets =100,000/mm^3
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding
* Other medical conditions which preclude study participation, in the opinion of the investigator
* Receiving treatment with any other investigational product

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prima BioMed Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Heidy Gray, MD
Address 0 0
University of Washington
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01617629