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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03113942




Registration number
NCT03113942
Ethics application status
Date submitted
8/03/2017
Date registered
14/04/2017
Date last updated
31/03/2022

Titles & IDs
Public title
Study of Pomalidomide in Anal Cancer Precursors
Scientific title
Study of Pomalidomide in Anal Cancer Precursors (SPACE): a Phase 2 Study of Immunomodulation in People With Persistent HPV-associated High Grade Squamous Intraepithelial Lesions
Secondary ID [1] 0 0
SPACE
Universal Trial Number (UTN)
Trial acronym
SPACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Grade Squamous Intra-epithelial Lesion (HSIL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pomalidomide 2 MG Oral Capsule [Pomalyst]

Experimental: Pomalidomide group - Open label - all participants will receive pomalidomide 2mg orally once a day for 6 cycles (21 days on treatment and a 7 day rest period constitutes a cycle).


Treatment: Drugs: Pomalidomide 2 MG Oral Capsule [Pomalyst]
Pomalidomide is an oral immunomodulatory derivative of thalidomide. Thalidomide and its derivatives are small molecules with broad effects on immune activation, including T-cell activation and responsiveness. Pomalidomide augments T cell responsiveness and proliferation by several mechanisms, many mediated by transcriptional regulation downstream of its primary target, cereblon. Effects include increased production of IL-2 and interferon-? (IFN-?), enhanced CD4+ and CD8+ T cell co-stimulation.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Histological High Grade Squamous Intraepithelial Lesions (HSIL) clearance at 6 months of therapy
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
incidence of grade 3 and 4 adverse events and therapy delays (tolerability)
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
number of subjects completing of full six month course
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
effect of pomalidomide on self-reported health related quality of life and cancer anxiety during and after therapy
Timepoint [3] 0 0
6 months

Eligibility
Key inclusion criteria
1. Persistent high grade squamous intra-epithelial lesion (HSIL) which must meet all of the following criteria:

i. Pathologically confirmed grade 2 or 3 AIN demonstrated by high resolution anoscopy with grade on each occasion re-confirmed at screening by nominated study pathologist from Douglas Hanly Moir (DHM) (pathology case review to be conducted prior to enrolment) ii. Lesion must have been visualised on at least three sequential occasions over at least 12 months, including the pre enrolment screening high resolution anoscopy (HRA).

iii. Lesion must have persistent geographical characteristics consistent with a single lesion observed over time (as defined in the Manual of Operations).
2. No history of thromboembolic disease
3. No evidence of anal cancer or Superficially Invasive Squamous Cell Carcinoma of the Anus (SISCCA)
4. Willingness to use appropriate contraception (including refraining from sperm donation)
5. Age 18 years or older
6. Provision of written informed consent

In addition, for subjects with HIV:
7. Adherence to a stable suppressive antiretroviral therapy (ART) regimen, unchanged for at least two months
8. CD4+ count = 200 cells/µl
9. HIV viral load < 200 copies/mL for at least six months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Absolute neutrophil count (ANC) <1000 cells/µL
2. Haemoglobin <10.0 g/dL
3. Platelet count <75,000 cells/µL
4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > three times upper limit of normal
5. Calculated or measured creatinine clearance (CLCr) = 50 mL/min (calculated by Cockcroft-Gault formula)
6. Patients with significant cardiac dysfunction including congestive heart failure, NY Heart Association Class II; Myocardial infarction within 12 months of starting study; unstable of poorly controlled angina
7. Current pregnancy or breastfeeding
8. Any condition not already outlined above which, in the opinion of the clinical investigator, would place the subject at risk if they participated or would jeopardise adherence or follow up

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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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 not provided in https://clinicaltrials.gov/study/NCT03113942