Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr B A Zonnenberg


Contact details

University Medical Centre Utrecht (UMCU)
Department of Medical Oncology
Heidelberglaan 100
3584 CX
+31 (0)30 250 6308

Additional identifiers

EudraCT number number

Protocol/serial number

CSTI571BNL07; METC 03-044

Study information

Scientific title


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


Secondary study design


Trial setting


Trial type


Patient information sheet


Medullary thyroid carcinoma


Oral treatment with 600 - 800 mg imatinib daily.

Intervention type



Phase II

Drug names

Imatinib mesylate (Glivec®)

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

University Medical Centre Utrecht (UMCU)
3584 CX

Sponsor information


University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
3508 GA

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Novartis Pharma B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Results in

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