A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours (NCT01396408) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours
Canada137 participantsStarted 2012-02-09
Plain-language summary
This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy can cause this cancer to shrink for a time, better options are needed.
Who can participate
Age range16 Years
SexALL
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Eligibility Criteria - ALL Patients
Patients must have histologically or cytologically confirmed diagnosis of a rare tumour as follows:
1. Vascular sarcomas: Angiosarcoma, hemangiosarcoma, hemangiopericytoma, hemangioblastomas;
2. Clear cell carcinomas of the ovary, endometrium;
3. Medullary thyroid carcinoma;
4. Neuroendocrine tumours: paragangliomas and pheochromocytomas only;
5. Adrenocorticocarcinoma;
6. Thymic carcinoma;
7. Fibrolamellar hepatocellular carcinoma;
8. Exploratory genetic cohort for sunitinib: Rare tumours with somatic or germline mutations in sunitinib targets such as VEGFR, PDGFR, KIT, RET;
9. Exploratory genetic cohort for temsirolimus: Rare tumours arising from known or suspected germline mutations in mTOR pathway such as PTEN, TS1/2, LKB1, NF1/2 or somatic mutations in the mTOR pathway such as mutation or amplification of P13K or AKT;
10. Unspecified cohort for exploratory evaluation. The unspecified histologies must also be rare tumours for which there are no traditional phase II clinical trials and for which there are clinical activity or laboratory data to support the likely sensitivity to the agents.
11. Ewing's Sarcoma Family of Tumours (ESFT) - relapsed or refractory.
* Patients must have unresectable, locally advanced or metastatic disease for which there are no known life prolonging standard therapies.
* Patients must have tumour tissue from their primary tumour available
* Presence of clinically and/or radiologically documented …