ODM-207 in Patients With Advance Solid Tumours | NCT03035591

Studies
ODM-207 in Patients With Advance Solid Tumours

NCT03035591

Sponsor

Orion Corporation, Orion Pharma

Status

Completed

Last Update Posted

Oct 15, 2019Actual

Enrollment

36Actual

Phase

Phase 1Phase 2

Conditions

Solid Tumors

Interventions

ODM-207

Countries

Finland

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

Status Module

Record Verification Date

Oct 2019

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 22, 2016Actual

Primary Completion Date

May 10, 2019Actual

Completion Date

May 10, 2019Actual

First Submitted Date

Jan 20, 2017

First Submission Date that Met QC Criteria

Jan 25, 2017

First Posted Date

Jan 30, 2017Estimated

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

Oct 14, 2019

Last Update Posted Date

Oct 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of ODM-207.

Detailed Description

Not provided

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Label	Type	Description	Intervention Names
ODM-207	Experimental	Escalating doses of ODM-207	Drug: ODM-207

Name	Type	Description	Arm Group Labels	Other Names
ODM-207	Drug		ODM-207

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose	Highest dose level at which <33% of patients in a cohort experience Dose Limiting Toxicity (DLT)	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy
Life expectancy >12 weeks
Patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression
ECOG performance status of 0 to 1

Exclusion Criteria:

History of bleeding disorder or significant bleeding episode within 6 months prior to study treatment
Subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment)
History of or current leptomeningeal or brain metastasis or spinal cord compression.

Accepts Healthy Volunteers

Sex

All

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
Johann De Bono	ICR/Royal Marsden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital, Department of Oncology		Helsinki		00029	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32989226	Derived	Ameratunga M, Brana I, Bono P, Postel-Vinay S, Plummer R, Aspegren J, Korjamo T, Snapir A, de Bono JS. First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours. Br J Cancer. 2020 Dec;123(12):1730-1736. doi: 10.1038/s41416-020-01077-z. Epub 2020 Sep 29.