Precision Cancer Therapy in Rare Cancers | NCT06119789

Studies
Precision Cancer Therapy in Rare Cancers

NCT06119789

Sponsor

Oslo University Hospital

Status

Recruiting

Last Update Posted

Mar 26, 2025Actual

Enrollment

96Estimated

Phase

Phase 2

Conditions

Rare Malignant Neoplasm

Interventions

Imatinib
Trametinib
Dabrafenib

Countries

Norway

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2025Actual

Primary Completion Date

Nov 30, 2033Estimated

Completion Date

Aug 1, 2036Estimated

First Submitted Date

May 25, 2023

First Submission Date that Met QC Criteria

Nov 1, 2023

First Posted Date

Nov 7, 2023Actual

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

Mar 23, 2025

Last Update Posted Date

Mar 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Åslaug Helland, Professor, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Name	Class
Helse Stavanger HF	OTHER_GOV
University Hospital of North Norway	OTHER
StOlavs Hospital	UNKNOWN
Nordlandssykehuset HF

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Some rare cancers are hard-to-treat and patients have a poor prognosis. It is known that some of these patients have targetable molecular alterations, and some benefit from targeted drugs. However in many cases these drugs are not approved for the rare cancers.

In this study the aim is to do advanced molecular diagnostics to identify possible targets for therapy, and to treat accordingly.

Detailed Description

All patients will have the tumour cells diagnosed with a large genepanel, analyzing more than 500 genes on DNA / RNA level. Patients will be treated based on the molecular characteristics of the tumor cells.

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

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment according to genetic alterations	Experimental	treatment according to genetic alterations	Drug: Imatinib Drug: Trametinib Drug: Dabrafenib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imatinib	Drug	imatinib treatment based on molecular alterations	treatment according to genetic alterations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiological response evaluation at 16 weeks of treatment	Standard radiological response evaluation, like RECIST criteria.	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Molecular analyses predicting responses	Sequencing of tumor material and blood samples	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ECOG 0-2,
identified biomarker,
reasonable biochemistry

Exclusion Criteria:

ECOG 3-5
serious other diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Åslaug Helland, MD PhD	Contact	+4795940863		ahelland@medisin.uio.no
Kathinka Slørdahl, MD PhD	Contact			katslo@ous-hf.no

Overall Officials

Name	Affiliation	Role
Sigbjørn Smeland, MD PhD	Oslo University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital	Recruiting	Oslo		0310	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068877	Imatinib Mesylate
C560077	trametinib
C561627	dabrafenib

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided