A phase II study to investigate the effect of Glivec® (imatinib mesylate, formerly known as STI571) in patients with inoperable medullary thyroid carcinoma
| ISRCTN | ISRCTN13256080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13256080 |
| Secondary identifying numbers | CSTI571BNL07; METC 03-044 |
- Submission date
- 23/02/2007
- Registration date
- 23/02/2007
- Last edited
- 20/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B A Zonnenberg
Scientific
Scientific
University Medical Centre Utrecht (UMCU)
Department of Medical Oncology
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Phone | +31 (0)30 250 6308 |
|---|---|
| B.Zonnenberg@umcutrecht.nl |
Study information
| Study design | Observational phase II study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Single-centre |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Medullary thyroid carcinoma |
| Intervention | Oral treatment with 600 - 800 mg imatinib daily. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 11/07/2003 |
| Completion date | 11/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 11/07/2003 |
| Date of final enrolment | 11/07/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Industry
Novartis Pharma B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2007 | Yes | No |
