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mTOR inhibitor
Sapanisertib + Ziv-Aflibercept for Advanced Cancer
Phase 1
Waitlist Available
Led By Aung Naing
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
Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
Patients with advanced or metastatic cancer that is refractory to standard therapy or relapsed after standard therapy; patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to up to day 8 of cycle 1
Awards & highlights
Study Summary
This trial is studying whether a combination of sapanisertib and ziv-aflibercept is safe and effective in treating patients with solid tumors that have come back or spread.
Who is the study for?
This trial is for patients with recurrent solid tumors that are metastatic or inoperable, who have tried standard treatments without success. They must be generally healthy with a life expectancy over 3 months, have acceptable organ function test results, and not be pregnant or breastfeeding. Participants should use effective contraception and cannot join if they've had certain recent treatments, brain metastases, uncontrolled diseases like HIV or severe heart conditions.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Sapanisertib and Ziv-Aflibercept. Sapanisertib blocks enzymes needed for cell growth while Ziv-Aflibercept aims to prevent tumor growth by inhibiting blood vessel formation. The goal is to determine the safest doses and observe how well these drugs work together against advanced solid tumors.See study design
What are the potential side effects?
Potential side effects include problems related to liver function (elevated bilirubin), blood disorders (low counts of white cells, neutrophils, platelets), digestive issues due to malabsorption from previous surgeries or diseases, high blood sugar levels which could indicate diabetes risk, as well as general risks associated with pregnancy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
My advanced cancer is not responding to standard treatments.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to up to day 8 of cycle 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to up to day 8 of cycle 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicity
Maximum tolerated dose (MTD)
Secondary outcome measures
Changes in phosphorylated expression of AKT, S6, PTEN, and CD31
Changes in phosphorylated expression of AKT, pS6, PTEN, and CD31
Changes in total expression of AKT, pS6, PTEN, and CD31
+3 moreSide effects data
From 2018 Phase 2 trial • 118 Patients • NCT02049957100%
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%
Drug reaction with eosinophilia and systemic symptoms
17%
Deafness neurosensory
17%
Proteinuria
17%
International normalised ratio increased
17%
Skin infection
17%
Hyponatraemia
17%
Pleurisy
17%
Ataxia
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, ziv-aflibercept)Experimental Treatment2 Interventions
Patients receive sapanisertib PO QD on days 2-4, 9-11, 16-18, and 23-25 and ziv-aflibercept IV over 60 minutes on days 1 and 15. 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
Ziv-Aflibercept
2008
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,584 Total Patients Enrolled
Aung NaingPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
623 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have brain metastases.I do not have any ongoing serious illnesses or infections.I have had a stroke or a procedure to open my blood vessels.I started bisphosphonates more than 30 days before starting MLN0128.I have a tumor that can be biopsied, preferably pancreatic or ovarian cancer.My diabetes is not well-controlled, with high blood sugar or HbA1c levels.I have severe heart valve problems or have had a valve replacement.My heart's electrical cycle is longer than normal or I have a history of specific heart rhythm problems.I do not have hepatitis B or C.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have no major side effects from past treatments.I can swallow pills.I have a slow heartbeat that causes symptoms.I haven't had any cancer treatment or experimental therapy in the last 4 weeks and have recovered from side effects.I am fully active and can carry on all pre-disease activities without restriction.I have had a heart issue like angina or a procedure to open my heart's arteries.I have had a pulmonary embolism.My kidney function, measured by creatinine levels, is within the normal range.I haven't had serious gut issues or surgeries affecting my digestion in the last month.My blood pressure has been very high on more than one occasion in the last 3 months.I do not have bleeding disorders or non-healing wounds.I do not need heart medication (other than digoxin) or have serious heart rhythm problems.My urine protein levels are low enough for me to enroll.My warfarin dose has been unstable or my INR was above 3 in the last month.I have not had any significant medical events in the last 6 months.I have not taken PPIs in the last 7 days or H2 blockers in the last 24 hours.My advanced cancer is not responding to standard treatments.I have severe heart failure or very high cholesterol not controlled by medication.I do not have serious heart or lung disease currently.I am not pregnant or breastfeeding.My asthma is not under control, or my oxygen levels are below 90% without assistance.I have high blood pressure in the lungs.I am not pregnant, won't get pregnant, and will use two forms of birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sapanisertib, ziv-aflibercept)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards have been linked to Sapanisertib usage?
"The safety of Sapanisertib has been evaluated to be a 1 on the scale of 1-3. This tentative assessment is based on this being a Phase 1 trial, which implies only limited data exists in regards to efficacy and safety."
Answered by AI
Are persons eligible to partake in this trial at the current moment?
"This specific medical trial is no longer accepting participants. It was initially posted on June 3rd 2014 and most recently modified on August 11th 2022. For those researching alternative studies, there are currently 4781 trials actively recruiting for metastatic malignant solid neoplasm and 55 separate clinical trails that involve Sapanisertib are looking for volunteers."
Answered by AI
Under what circumstances is Sapanisertib typically prescribed?
"Sapanisertib is typically employed as a remedy for wet age-related macular degeneration (wAMD). It may also be effective at ameliorating other conditions, including diabetic macular edema (DME) and general macular degeneration."
Answered by AI
What is the maximum capacity of participants for this experiment?
"Unfortunately, no more participants are being accepted for this clinical trial. It was initially published on June 3rd 2014 and edited most recently on August 11th 2022. However, there is still hope - 4781 studies are currently enrolling patients with metastatic malignant solid neoplasms and 55 trials require recruits for Sapanisertib interventions."
Answered by AI
What are the foremost goals of this research endeavor?
"The primary aim of this trial is to determine the Maximum tolerated dose (MTD) over a period spanning 4 weeks post-treatment. Secondary objectives include observing Changes in total expression of AKT, ribosomal protein S6 (S6), phosphatase and tensin homolog (PTEN), and CD31 with reverse phase protein array; evaluating Changes in phosphorylated expression of AKT, pS6, PTEN, and CD31 using immunohistochemistry; as well as assessing Changes in tumor size via waterfall plot correlation coefficients."
Answered by AI
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