RAD001 in Pheochromocytoma or Nonfunctioning Carcinoid (NCT01152827) | Clinical Trial Compass
CompletedPhase 2
RAD001 in Pheochromocytoma or Nonfunctioning Carcinoid
South Korea33 participantsStarted 2008-07
Plain-language summary
* According to Martin F et al, AKT is highly phosphorylated in phenochromocytoma but not in benign adrenocortical tumors.
* In nonfunctioning carcinoid, the PI3K/AKT/mTOR pathway is activated.
* Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on mTOR inhibition by RAD001 have been conducted in pheochromocytoma or extra-adrenal paraganglioma or non-functioning carcinoid.
* So we design this phase II study of RAD001 in pheochromocytoma or extra-adrenal paraganglioma or non-functioning carcinoid to evaluate the efficacy of RAD001 in this orphan disease.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Histologically or cytologically confirmed pheochromocytoma or extra-adrenal paraganglioma or carcinoid
* 2\. Local, locally-advanced or metastatic disease documented as having shown progression on a scan (CT, MRI, MIBI scan) taken 2 to 12 months prior to baseline compared to a previous scan taken at any time in the past. Progression must be documented according to RECIST criteria.
* 3\. Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent.
* 4\. Presence of at least one measurable target lesion for further evaluation according to RECIST criteria
* 5\. 18 years or older
* 6\. ECOG performance status 0, 1
* 7\. Previous treatment with chemotherapy, loco-regional therapy (e.g chemoembolization) are permitted providing that toxicity has resolved to ≤grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment.
* 8\. Adequate organ function
* 9\. A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
* 10\. A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.
Exclusion Criteria:
* 1\. A patient with no measurable disease
* 2\. Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-t…