NCT01137916

Brief Summary

The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

6.5 years

First QC Date

June 2, 2010

Last Update Submit

May 2, 2017

Conditions

Aggressive FibromatosisDesmoid Tumor

Outcome Measures

Primary Outcomes (1)

  • Non-progression rate after 6 months of treatment

    6 months

Secondary Outcomes (4)

  • Non-progression rate after 12 and 24 months of treatment

    12 and 24 months

  • Response rate

    12 and 24 months

  • Progression-free survival (PFS) and overall survival (OS)

    12 and 24 months

  • Recording of patient quality of life

    12 and 24 months

Study Arms (1)

drug

EXPERIMENTAL

Imatinib 800 mg

Drug: Imatinib

Interventions

ImatinibDRUG

800 mg

Also known as: Glivec
drug

Eligibility Criteria

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

You may qualify if:

  • Patients with histological confirmed aggressive fibromatosis (desmoid tumor)
  • Measurable disease according to the RECIST criteria
  • Evidence of relapse or disease progression within the last 6 months (based on RECIST criteria) in computed tomography or magnetic resonance imaging
  • No possibility of complete surgical resection or cases in which surgical therapy leaving a large tissue defect, functional deficit or disfigurement would be required
  • No possibility of curative radiotherapy with acceptable toxicity and/or late morbidity
  • Previous treatment of the tumor region by surgical intervention and/or radiotherapy and/or antihormonal therapy possible
  • Age \> or = 18 years
  • WHO PS \< or = 1
  • Effective contraception during study medication
  • Signed informed consent form

You may not qualify if:

  • Surgical intervention \< 4 weeks
  • Prior therapy with imatinib
  • Pregnancy or lactation
  • Severe hepatic dysfunction
  • Known allergic reaction to imatinib or one of its components
  • The following laboratory values: Absolute neutrophil count \< 1.5 x 103/mm3, Platelets \< 100,000/mm3, Serum creatinine \> or = 2.5 mg/dl, SGOT and/or SGPT \> 2.5 x ULN (upper limit of normal), Total bilirubin \> 1.5 x ULN
  • Participation in another study (four weeks before and during the study)
  • Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg, Mannheim University Medical Center

Mannheim, 68167, Germany

Location

Related Publications (2)

  • Kasper B, Gruenwald V, Reichardt P, Bauer S, Rauch G, Limprecht R, Sommer M, Dimitrakopoulou-Strauss A, Pilz L, Haller F, Hohenberger P. Imatinib induces sustained progression arrest in RECIST progressive desmoid tumours: Final results of a phase II study of the German Interdisciplinary Sarcoma Group (GISG). Eur J Cancer. 2017 May;76:60-67. doi: 10.1016/j.ejca.2017.02.001. Epub 2017 Mar 8.

    PMID: 28282612DERIVED

  • Kasper B, Gruenwald V, Reichardt P, Bauer S, Hohenberger P, Haller F. Correlation of CTNNB1 Mutation Status with Progression Arrest Rate in RECIST Progressive Desmoid-Type Fibromatosis Treated with Imatinib: Translational Research Results from a Phase 2 Study of the German Interdisciplinary Sarcoma Group (GISG-01). Ann Surg Oncol. 2016 Jun;23(6):1924-7. doi: 10.1245/s10434-016-5132-4. Epub 2016 Feb 9.

    PMID: 26861905DERIVED

Related Links

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Bernd Kasper, PD Dr. med.

    University of Heidelberg, Mannheim University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 7, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

DE(1)