NCT02290522

Brief Summary

Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA for identification of pts who could benefit from a personalized treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

10.6 years

First QC Date

October 8, 2014

Last Update Submit

October 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Median progression free survival (PFS)

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

    Median time from date of randomization to date of progression or death, assessed up to 100 months

Study Arms (1)

tumor biopsy

EXPERIMENTAL

Tumor biopsy for targeted treatment according to molecular profile

Procedure: Tumor biopsy

Interventions

Tumor biopsyPROCEDURE

Biopsy of lesion for molecular characterization

tumor biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Solid tumor
  • No standard treatment option
  • PS 0-1
  • Lesion assessable for biopsy
  • Measurable disease
  • Informed consent

You may not qualify if:

  • Life expectancy \< 3 months
  • Bone marrow suppression
  • Abnormal renal or hepatic function
  • Serious concurrent medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Related Publications (2)

  • Jacobsen IC, Spanggaard I, Hojgaard M, Belcaid L, Qvortrup C, Yde CW, Schmidt AY, Nielsen FC, Willemoe GL, Dam MS, Lassen U, Staal Rohrberg K. Extensive genomic analysis in patients with KRAS-mutated solid tumors shows high frequencies of concurrent alterations and potential targets but has limited clinical impact. Acta Oncol. 2022 Dec;61(12):1499-1506. doi: 10.1080/0284186X.2022.2156809. Epub 2022 Dec 18.

  • Tuxen IV, Rohrberg KS, Oestrup O, Ahlborn LB, Schmidt AY, Spanggaard I, Hasselby JP, Santoni-Rugiu E, Yde CW, Mau-Sorensen M, Nielsen FC, Lassen U. Copenhagen Prospective Personalized Oncology (CoPPO)-Clinical Utility of Using Molecular Profiling to Select Patients to Phase I Trials. Clin Cancer Res. 2019 Feb 15;25(4):1239-1247. doi: 10.1158/1078-0432.CCR-18-1780. Epub 2018 Oct 1.

Study Officials

  • Ulrik Lassen, MD, PH.D.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida V Tuxen, MD

CONTACT

Ulrik Lassen, MD, PH.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PH.D

Study Record Dates

First Submitted

October 8, 2014

First Posted

November 14, 2014

Study Start

May 1, 2013

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations