Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China

Novartis

Status and phase: Completed; Phase 4

Conditions: Pancreatic Neuroendocrine Tumors

Treatments: Drug: everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT02842749

CRAD001PCN31

Details and patient eligibility

About

To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.

Full description

This was an open-label, multicenter, single-arm clinical study to evaluate the safety and efficacy of everolimus in Chinese adult patients with locally advanced, unresectable or metastatic, well differentiated progressive pancreatic neuroendocrine tumors. The inclusion and exclusion criteria, as well as the dosing and dose modification criteria are designed according to the approved Chinese Package Insert. The planned sample size of the study was approximately 60 subjects.

Subjects who were eligible received the treatment with everolimus provided by sponsor to treat pNET and followed the visit schedule in the protocol to collect safety and efficacy data until progression of disease, unacceptable toxicity, death, protocol deviation or other reason that may lead to discontinuation before the end of study. All subjects were followed-up for survival status every 6 months by the investigator until death, lost to follow-up, withdrawal of consent for survival or end of study.

The "End of study" is defined as either at least 75% of subjects have completed survival follow up or all subjects discontinued study treatment or the last subject finished 5-year survival follow up, whichever comes first. Final analysis was conducted at the end of the study.

Enrollment: 61 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have histological confirmed G1 or G2 pancreatic neuroendocrine tumors(pNETs) (WHO 2010)
• Patients must have radiological documentation of progression of disease per RECIST 1.1 within 12 months prior to enrollment.
• Measurable disease per RECIST 1.1 criteria using triphasic computed tomography (CT) scan or multiphase MRI for radiologic assessment.
• everolimus treatment which is recommended by the treating physician

Exclusion criteria

• Hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.
• Patient who is unwilling to receive Afinitor treatment due to any reason.
• Pregnant or nursing (lactating) women,
• Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
• Use of an investigational drug within the 30 days prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

everolimus (single arm)

Experimental group

Description:

Participants were instructed to take everolimus at a starting dose of 10 mg orally once daily. However, dose adjustments were permitted in order to allow the participant to continue the study treatment.

Treatment:

Drug: everolimus