Condition category
Cancer
Date applied
23/02/2007
Date assigned
23/02/2007
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr B A Zonnenberg

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
Department of Medical Oncology
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 250 6308
B.Zonnenberg@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CSTI571BNL07; METC 03-044

Study information

Scientific title

Acronym

Study hypothesis

In the pathogenesis of medullary thyroid carcinoma a mutation of the rearranged during transfection (RET) tyrosine kinase system plays an essential role. In animal models the tyrosine kinase inhibitor imatinib showed tumor regression. So a phase II study in patients with progressive medullary thyroid carcinoma with imatinib may open new treatment possibilities.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Observational phase II study

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Medullary thyroid carcinoma

Intervention

Oral treatment with 600 - 800 mg imatinib daily.

Intervention type

Drug

Phase

Phase II

Drug names

Imatinib mesylate (Glivec®)

Primary outcome measures

The primary objective is to determine the objective response rate (partial and complete responses) in subjects with advanced medullary thyroid carcinoma.

Secondary outcome measures

1. To determine the time to tumour progression
2. To evaluate overall survival
3. To evaluate the safety profile of Glivec® in advanced medullary thyroid carcinoma

Overall trial start date

11/07/2003

Overall trial end date

11/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients over 18 years of age
2. The subject has advanced histologically proven medullary thyroid cancer. Advanced disease is defined as locally recurrent disease or metastatic disease that is not amenable to curative resection. The subject must have measurable disease.
3. The subject has not received anti-tumor radiotherapy or chemotherapy therapy within four weeks (six weeks for nitrosourea, mitomycin-C or any antibody therapy) of the start of imatinib administration
4. The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of zero to two
5. Adequate end organ function, defined as the following:
5.1. Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
5.2. Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2.5 x ULN
5.3. Creatinine less than 1.5 x ULN
5.4. Absolute neutrophil count (ANC) more than 1.5 x 10^9/L
5.5. Platelets more than 100 x 10^9/L
6. Female patients of childbearing potential must have negative pregnancy test within seven days before initiation of study drug dosing. Postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to three months following discontinuation of study drug.
7. Life expectancy of more than three months (in the absence of any intervention)
8. The subject has voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent prior to any study specific procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

1. The subject is less than five years free of another primary malignancy except:
1.1. If the other primary malignancy is not currently clinically significant nor requiring active intervention, or
1.2. If the other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ
2. The subject is with known brain metastases
3. The subject has received any other investigational agents within 28 days of first day of study drug dosing
4. The subject has a current history of a class three to four cardiovascular disability status in accordance with the New York Heart Association Functional Classification:
4.1. Class three is defined as marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes fatigue or dyspnea
4.2. Class four is defined as being unable to carry on any physical activity without symptoms and symptoms are present even at rest. Also, if any physical activity is undertaken, symptoms are increased
5. Female patients who are pregnant or breast-feeding
6. Patient has another severe and/or life-threatening medical disease
7. The subject has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis)
8. The subject has a known diagnosis of human immunodeficiency virus (HIV) infection
9. The subject has received chemotherapy within four weeks (six weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry
10. The subject had a major surgery within two weeks prior to study entry
11. The subject uses therapeutic anticoagulation with warfarins. Low-molecular weight heparin (e.g. Fragmin®) or heparin is permitted.
12. The subject with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

Recruitment start date

11/07/2003

Recruitment end date

11/07/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Industry

Funder name

Novartis Pharma B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17579194

Publication citations

  1. Results

    de Groot JW, Zonnenberg BA, van Ufford-Mannesse PQ, de Vries MM, Links TP, Lips CJ, Voest EE, A phase II trial of imatinib therapy for metastatic medullary thyroid carcinoma., J. Clin. Endocrinol. Metab., 2007, 92, 9, 3466-3469, doi: 10.1210/jc.2007-0649.

Additional files

Editorial Notes