Study to Allow for Second Treatment Cycle of DCVAC in Pat... | NCT02137746

Studies
Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer

NCT02137746

Sponsor

SOTIO a.s.

Status

Completed

Last Update Posted

May 24, 2017Actual

Enrollment

24Actual

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

Dendritic Cells DCVAC/PCa

Countries

Czechia

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

ID	Type	Description	Link
2013-003809-26	EudraCT Number

Status Module

Record Verification Date

Jun 2015

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

Dec 2013Actual

Primary Completion Date

Apr 2015Actual

Completion Date

Mar 20, 2017Actual

First Submitted Date

May 12, 2014

First Submission Date that Met QC Criteria

May 13, 2014

First Posted Date

May 14, 2014Estimated

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

May 23, 2017

Last Update Posted Date

May 24, 2017Actual

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

Description Module

Brief Summary

The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.

Detailed Description

Same as brief summary

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DCVAC/PCa Arm	Experimental	Dendritic Cells DCVAC/PCa Experimental therapy	Biological: Dendritic Cells DCVAC/PCa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dendritic Cells DCVAC/PCa	Biological	DCVAC/PCa Experimental therapy	DCVAC/PCa Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety evaluation of the second cycle of DCVAC	Safety evaluation of the second cycle of active cellular immunotherapy, which includes a second leukapheresis procedure, who after primary radical prostatectomy completed first cycle of active cellular immunotherapy in clinical trial SP003 without objective disease progression requiring additional anti-tumor therapy.	52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to Prostate Specific Antigen (PSA) Doubling Time		52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male 18 years and older
Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2)
Post radical Primary Prostatectomy
Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease

Exclusion Criteria:

Prior androgen deprivation therapy for prostate cancer
Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
Other uncontrolled intercurrent illness
Treatment with immunotherapy against PCa
Clinically significant cardiovascular disease
Active autoimmune disease requiring treatment

Accepts Healthy Volunteers

Sex

Male

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tomas Scheiner, PhD	Sotio Biotech Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Hradec Králové			Czechia

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided