NL-OMON35047
Completed
Phase 2
A phase II study to investigate the efficacy of RAD001 (Afinitor ®, everolimus) in patients with irresectable recurrent or metastatic differentiated, undifferentiated (anaplastic) and medullary thyroid carcinoma - THYRRAD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 42
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •\* Age \> 18 years
- •\* Karnofsky performance score \> 70%
- •\* Patients with differentiated thyroid carcinoma (i.e. papillary and follicular carcinomas)
- •\* Patients must have undergone total thyroidectomy (and having received thyrosuppressive therapy afterwards)
- •\* Patients with no RaI uptake in tumor as proven by RaI scintigraphy performed after prior RaI therapy
- •\* Patients with insufficient RaI uptake as proven by progression of lesions despite accumulation of RaI
- •\* Patients with a maximum cumulative dosis of RaI
- •\* The patient has documented progressive disease (PD) on computerized tomography (CT), magnetic resonance imaging (MRI), bone scan or X\-ray, per RECIST v1\.1 at screening compared with a previous image done within 14 months of screening
- •\* The subject has no other diagnosis of malignancy (unless non\-melanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed \* 2 years previously) and currently has no evidence of malignancy (unless non\-melanoma skin cancer or carcinoma in situ of the cervix).
Exclusion Criteria
- •Exclusion Criteria:
- •\* Patients receiving chemotherapy, immunotherapy, radiation therapy or any other investigational agent within 4 weeks of the first dose of study drug, or sunitinib and/or sorafenib within 2 weeks of the first dose of RAD001\. Patients must have recovered from effects of prior therapy.
- •\* Patients who have previously received RAD001 or other mTOR inhibitors.
- •\* Patients with known hypersensitivity to RAD001 or other rapamycin analogs (sirolimus, temsirolimus), or to its excipients.
- •\* Patients receiving chronic, systemic treatment with corticosteroids or another
- •immunosuppressive agent (except corticosteroids with a daily dosage equivalent to
- •prednisone \* 20 mg for adrenal insufficiency). Patients receiving corticosteroids must be on a stable dose for \* 4 weeks prior to the first dose of RAD001\. Topical or inhaled corticosteroids are permitted.
- •\* Patients with an active bleeding diathesis.
- •\* Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g., intra\-thoracic, intra\-abdominal, or intra\-pelvic), open biopsy, or significant traumatic injury, or who have not recovered from the side effects of any of the above.
- •\* Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction \* 6 months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis or severely impaired lung function.
Outcomes
Primary Outcomes
Not specified
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