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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01190176




Registration number
NCT01190176
Ethics application status
Date submitted
26/08/2010
Date registered
27/08/2010

Titles & IDs
Public title
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
Scientific title
Gynaecological Follow-up of a Subset of HPV-015 Study Subjects
Secondary ID [1] 0 0
2009-017282-35
Secondary ID [2] 0 0
113617
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Papillomavirus 0 0
Pancreatic Cancer 0 0
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Gynaecological follow-up
Treatment: Other - Cervarix
Treatment: Other - Placebo control
Treatment: Drugs - Demcizumab
Treatment: Drugs - Abraxane®
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Demcizumab

Experimental: HPV-062 study subjects Group - HPV-015 (NCT00294047) study subjects who had normal cervical cytology, but tested positive for oncogenic HPV infection at their concluding HPV-015 (NCT00294047) study visit or were pregnant, so that no cervical sample could be collected at their concluding HPV-015 (NCT00294047) study visit.

Experimental: Gemcitabine and demcizumab With or Without Abraxane® - Gemcitabine and demcizumab With or Without Abraxane®

Experimental: Carboplatin and Pemetrexed plus demcizumab - Carboplatin and Pemetrexed plus demcizumab

Experimental: Pemetrexed plus demcizumab - Pemetrexed plus demcizumab


Treatment: Surgery: Gynaecological follow-up
Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.

Treatment: Other: Cervarix
Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Treatment: Other: Placebo control
Subjects received 3 doses of the control \[Al(OH)3\] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.

Treatment: Drugs: Demcizumab
Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if you are enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab administered once every 2 weeks, and gemcitabine and Abraxane® administered weekly for 3 weeks, out of every 4 weeks. After 9 weeks, you will undergo assessments to determine the status of your disease. If there is no evidence of progression of your disease or if your tumor is smaller, you will continue to receive one additional infusion of demcizumab, and you will continue to receive infusions of gemcitabine and Abraxane® once weekly for 3 consecutive weeks out of every 4 weeks until it has been shown that your cancer has progressed. You will undergo assessments every 8 weeks thereafter to determine the status of your disease.

Treatment: Drugs: Abraxane®
Abraxane® which will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes once a week for 3 weeks in a row, followed by a week of rest.

Treatment: Drugs: Gemcitabine
Gemcitabine will be administered intravenously over 30 minutes initially at a dose of 1000 mg/m2 once a week for 3 weeks in a row, followed by a week of rest. If you develop side effects during this time period, your physician may decide to hold or reduce the dose of gemcitabine.

Treatment: Drugs: Demcizumab
The 6 subjects in the first cohort will receive demcizumab 5 mg/kg once every 3 weeks; the 6 subjects in the subsequent cohort will be treated with 10 mg/kg once every 3 weeks; and the 6 subjects in the final cohort will be treated with 15 mg/kg once every 3 weeks. A Data Safety Monitoring Board (DSMB) will review the data for the 6 subjects in each dose cohort after the last subject in that cohort has been on study for 56 days and then decide whether it is safe to escalate to the next highest dose cohort. Once the dose-escalation portion of the study has been completed, 14 additional subjects will be treated at the highest dose level that the DSMB deems as safe.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Other
Intervention code [3] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 12
Timepoint [1] 0 0
At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [2] 0 0
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 24
Timepoint [2] 0 0
At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [3] 0 0
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 36
Timepoint [3] 0 0
At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [4] 0 0
Number of Subjects Reporting Positive Oncogenic HPV DNA Results by Hybrid Capture II Test (HCII) at Month 48
Timepoint [4] 0 0
At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [5] 0 0
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 12
Timepoint [5] 0 0
At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [6] 0 0
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 24
Timepoint [6] 0 0
At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [7] 0 0
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 36
Timepoint [7] 0 0
At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [8] 0 0
Number of Subjects With Any Cytological Abnormalities in Cervical Samples by ThinPrep PapTest at Month 48
Timepoint [8] 0 0
At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [9] 0 0
Number of Subjects With Referral to Colposcopy at Month 12
Timepoint [9] 0 0
At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [10] 0 0
Number of Subjects With Referral to Colposcopy at Month 24
Timepoint [10] 0 0
At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [11] 0 0
Number of Subjects With Referral to Colposcopy at Month 36
Timepoint [11] 0 0
At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [12] 0 0
Number of Subjects With Referral to Colposcopy at Month 48
Timepoint [12] 0 0
At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [13] 0 0
Number of Subjects With Referral to Treatment at Month 12
Timepoint [13] 0 0
At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [14] 0 0
Number of Subjects With Referral to Treatment at Month 24
Timepoint [14] 0 0
At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [15] 0 0
Number of Subjects With Referral to Treatment at Month 36
Timepoint [15] 0 0
At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [16] 0 0
Number of Subjects With Referral to Treatment at Month 48
Timepoint [16] 0 0
At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Primary outcome [17] 0 0
To determine the maximum tolerated dose of demcizumab (OMP-21M18) when combined with gemcitabine +/- Abraxane®
Timepoint [17] 0 0
Until disease progression
Primary outcome [18] 0 0
To the determine the maximum tolerated dose of demcizumab (OMP-21M18) plus carboplatin and pemetrexed
Timepoint [18] 0 0
When each patient in the dose cohort reaches Day 56
Secondary outcome [1] 0 0
Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study
Timepoint [1] 0 0
At the time of completion or termination visit (up to 298 weeks)
Secondary outcome [2] 0 0
Percentage of Subjects in Clinical Remission
Timepoint [2] 0 0
At the time of completion or termination visit (up to 298 weeks)
Secondary outcome [3] 0 0
To determine the safety of gemcitabine +/- Abraxane® plus demcizumab (OMP-21M18)
Timepoint [3] 0 0
Until disease progression
Secondary outcome [4] 0 0
To determine the rate of immunogenicity of gemcitabine +/- Abraxane® plus demcizumab (OMP-21M18)
Timepoint [4] 0 0
Until disease progression
Secondary outcome [5] 0 0
To determine the preliminary efficacy of gemcitabine +/- Abraxane® plus demcizumab (OMP-21M18)
Timepoint [5] 0 0
Until disease progression
Secondary outcome [6] 0 0
To determine population pharmacokinetics of demcizumab (OMP-21M18)
Timepoint [6] 0 0
Until disease progression
Secondary outcome [7] 0 0
To determine the exploratory biomarker changes of gemcitabine plus demcizumab (OMP-21M18)
Timepoint [7] 0 0
Until disease progression
Secondary outcome [8] 0 0
To determine the safety of carboplatin and pemetrexed plus demcizumab (OMP-21M18)
Timepoint [8] 0 0
until treatment termination plus 30 days
Secondary outcome [9] 0 0
To determine the rates of immunogenicity of carboplatin and pemetrexed plus demcizumab (OMP-21M18)
Timepoint [9] 0 0
Up to 12 weeks post treatment termination
Secondary outcome [10] 0 0
To determine the preliminary efficacy of carboplatin and pemetrexed plus demcizumab (OMP-21M18)
Timepoint [10] 0 0
Until disease progression
Secondary outcome [11] 0 0
To determine population pharmacokinetics
Timepoint [11] 0 0
Day 21 and 63
Secondary outcome [12] 0 0
To determine the exploratory biomarker changes of carboplatin and pemetrexed plus demcizumab (OMP-21M18)
Timepoint [12] 0 0
Until Day 112

Eligibility
Key inclusion criteria
* Written informed consent obtained from the subject prior to enrolment.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A subject previously enrolled in the study NCT00294047 and who fulfils either of the following criteria:

* displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding NCT00294047 study visit
* was pregnant so that no cervical sample could be collected at her concluding NCT00294047 study visit
Minimum age
28 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* A subject who at the NCT00294047 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
* A subject who at the NCT00294047 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her NCT00294047 exit colposcopy.
* A subject for whom the cervical cytology results from the concluding NCT00294047 study visit were unavailable for reasons other than pregnancy.

Study design
Purpose of the study
Prevention
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 3
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
12/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2017
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
VIC,NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
301 - Parkville
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
The Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [6] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [7] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Parkville
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Washington
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
Netherlands
State/province [9] 0 0
Rotterdam
Country [10] 0 0
Portugal
State/province [10] 0 0
Almada
Country [11] 0 0
Portugal
State/province [11] 0 0
Coimbra
Country [12] 0 0
Portugal
State/province [12] 0 0
Lisboa
Country [13] 0 0
Portugal
State/province [13] 0 0
Setúbal
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Moscow
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Sankt-Petersburg
Country [16] 0 0
Singapore
State/province [16] 0 0
Singapore
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Manchester
Country [19] 0 0
United States of America
State/province [19] 0 0
California
Country [20] 0 0
United States of America
State/province [20] 0 0
Colorado
Country [21] 0 0
United States of America
State/province [21] 0 0
Georgia
Country [22] 0 0
United States of America
State/province [22] 0 0
Louisiana
Country [23] 0 0
United States of America
State/province [23] 0 0
Maryland
Country [24] 0 0
United States of America
State/province [24] 0 0
New Jersey
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
New Zealand
State/province [26] 0 0
Christchurch
Country [27] 0 0
New Zealand
State/province [27] 0 0
Hamilton
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Novotech (Australia) Pty Limited
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study is available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/SearchAllPostings.aspx?searchparam=113617


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01190176