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mTOR Inhibitor

Sapanisertib for Pancreatic Neuroendocrine Carcinoma

Phase 2
Waitlist Available
Led By Lakshmi Rajdev
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 years
Awards & highlights

Study Summary

This trial studies a drug to treat patients with pancreatic neuroendocrine tumors that have spread, stopped responding to treatment, or cannot be removed surgically.

Eligible Conditions
  • Refractory Pancreatic Neuroendocrine Carcinoma
  • Pancreatic Neuroendocrine Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for 2 years, every 6 months for the 3rd year, then annually up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate
Secondary outcome measures
Disease Control Rate
Duration of Response
Progression-free Survival (PFS)

Side effects data

From 2018 Phase 2 trial • 118 Patients • NCT02049957
100%
Nausea
83%
Stomatitis
67%
Fatigue
50%
Hyperglycaemia
50%
Dysgeusia
50%
Diarrhoea
50%
Pruritus
33%
Urinary tract infection
33%
Decreased appetite
33%
Arthralgia
33%
Weight decreased
33%
Aspartate aminotransferase increased
33%
Headache
33%
Alanine aminotransferase increased
33%
Dyspepsia
33%
Myalgia
17%
Sinusitis
17%
Deafness neurosensory
17%
Proteinuria
17%
International normalised ratio increased
17%
Skin infection
17%
Hyponatraemia
17%
Pleurisy
17%
Ataxia
17%
Drug reaction with eosinophilia and systemic symptoms
17%
Dehydration
17%
Hypoxia
17%
Rash maculo-papular
17%
Dry skin
17%
Eye pain
17%
Mental status changes
17%
Vomiting
17%
Pyrexia
17%
Blood creatinine increased
17%
Electrocardiogram QT prolonged
17%
Hypophosphataemia
17%
Hypercalcaemia
17%
Joint swelling
17%
Back pain
17%
Neck pain
17%
Dizziness
17%
Tremor
17%
Paraesthesia
17%
Hyperaesthesia
17%
Restless legs syndrome
17%
Serotonin syndrome
17%
Thrombosis in device
17%
Anxiety
17%
Constipation
17%
Hyperlipidaemia
17%
Sepsis
17%
Dyspnoea
17%
Blood alkaline phosphatase increased
17%
Cough
17%
Hypoaesthesia
17%
Rhinorrhoea
17%
Rash pruritic
17%
Palmar-plantar erythrodysaesthesia syndrome
17%
Pneumonia
17%
Dysuria
17%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 (Part 1): Sapanisertib 5 mg + Exemestane
Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant
Phase 1 (Part 2): Sapanisertib 3 mg + Exemestane
Phase 1 (Part 2): Sapanisertib 3 mg + Fulvestrant
Phase 1 (Part 2): Sapanisertib 4 mg + Exemestane
Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Sensitive)
Phase 2: Sapanisertib 4 mg + Exemestane (Everolimus Resistant)
Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Sensitive)
Phase 2: Sapanisertib 4 mg+Fulvestrant (Everolimus Resistant)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (sapanisertib)Experimental Treatment1 Intervention
Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sapanisertib
2016
Completed Phase 2
~840

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,310 Total Patients Enrolled
5 Trials studying Pancreatic Neuroendocrine Carcinoma
1,894 Patients Enrolled for Pancreatic Neuroendocrine Carcinoma
Lakshmi RajdevPrincipal InvestigatorECOG-ACRIN Cancer Research Group
4 Previous Clinical Trials
680 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Sapanisertib been the focus of prior research studies?

"At this time, 11 trials are exploring the potential applications of Sapanisertib and none have advanced to Phase 3. Most of these investigations are happening in Boston, MA though there are nearly 2000 sites running clinical trials related to Sapanisertib worldwide."

Answered by AI

What is the current number of medical facilities actively conducting this research?

"100 individuals are currently being recruited for this medical trial, hosted at Essentia Health Saint Joseph's Medical Center in Brainerd, GenesisCare USA - Vegas Tenaya in Las Vegas, Longmont United Hospital in Longmont and additional sites."

Answered by AI

What is the total number of participants involved in this research trial?

"Unfortunately, this clinical trial is no longer seeking new patients. It was initially listed on February 1st 2017 and the last update occured on September 23rd 2022. For those exploring other studies, there are 2530 active trials for neuroendocrine tumors as well as 11 actively recruiting participants for Sapanisertib medication."

Answered by AI

Has the Food and Drug Administration authorized Sapanisertib for public use?

"According to our internal assessment, Sapanisertib has been assigned a safety rating of 2. This is because the medication is currently in Phase 2 trials and there have only been studies demonstrating its safety - not efficacy."

Answered by AI

Are there any current opportunities to join this clinical trial?

"At this moment, the study is not searching for new participants. Initially posted on February 1st 2017 and last edited September 23rd 2022, it does not require any additional candidates at present. If you are exploring other studies related to neuroendocrine tumors, 2530 clinical trials presently accept patients while 11 different experiments seek those taking Sapanisertib as part of their treatment regime."

Answered by AI

What are the projected results of this experiment?

"This clinical trial's primary goal is to measure Objective Tumor Response (OTR) over a predetermined timeline, with assessment intervals of every 3 months for the first two years, then bi-annually up to five year. Secondary assessments include Disease Control Rate and Progression Free Survival. Duration of Reponse will be recorded by quantifying the time from OTR occurrence until disease progression or death without it. The evaluation criteria are based on RECIST Version 1.1 standards which define Complete Response as disappearance of all lesions with any pathological lymph nodes reduced to less than 10mm; Partial Reponse as at least 30% decrease in target les"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery
2017. "Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02893930.
~2 spots leftby Apr 2025
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