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mTOR Inhibitor

nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin) for Colorectal Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Aadi, LLC

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 through study completion (up to 50 months)

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat colorectal cancer.

Eligible Conditions

Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (up to 50 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (up to 50 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (up to 50 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting-toxicities (DLTs) (Phase 1)

Progression-free Survival at 6 Months (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)

Secondary outcome measures

Disease Control Rate (DCR) (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)

Median Progression-free Survival (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)

Overall Response Rate (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)

Side effects data

From 2022 Phase 1 & 2 trial • 60 Patients • NCT03439462

67%

Mucositis

58%

Fatigue

43%

Rash

38%

Diarrhea

37%

Myelosuppression (Thrombocytopenia)

35%

Nausea

30%

Myelossupression (Neutropenia)

28%

Hypertriglyceridemia

27%

Myelosuppression (Anemia)

27%

Weight decreased

25%

Decreased appetite

22%

Mucosal inflammation

18%

Hypokalemia

18%

Vomiting

18%

Lipase increased

18%

Dermatitis

17%

Epistaxis

17%

Dysgeusia

15%

Hyperglycemia

13%

Amylase increased

12%

Hypercholesterolemia

12%

Abdominal pain

10%

Infection

10%

Hypophosphataemia

10%

Headache

ALT

Anal inflammation

Dry mouth

AST

Proctalgia

Candida infection

Hypoalbuminaemia

Dehydration

Hypomagnesaemia

Dry eye

Application site pain

Dry skin

Alopecia

Gastrooesophageal reflux disease

Oedema peripheral

Dizziness

Taste disorder

Proteinuria

Hypertension

Nail disorder

Anorexia

Rectal perforation

Enterocolitis infectious

Pneumonia

Colitis

Stomatitis

100%

80%

60%

40%

20%

Study treatment Arm

Total

Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4

Cohort 2 Nab-Sirolimus 20 mg/m2 qw3/4

Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4

Trial Design

1Treatment groups

Experimental Treatment

Group I: nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin)Experimental Treatment1 Intervention

Single arm, open-label, multi-institutional study to identify the RP2D and determine the efficacy and safety profile of nab-sirolimus administered as first-line therapy in combination with mFOLFOX6 and bevacizumab in patients with metastatic CRC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

nab-sirolimus

2018

Completed Phase 2

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aadi, LLCLead Sponsor

7 Previous Clinical Trials

252 Total Patients Enrolled

Aadi Bioscience, Inc.Lead Sponsor

16 Previous Clinical Trials

481 Total Patients Enrolled

Frequently Asked Questions

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

Does this experiment only include those who are octogenarians or younger?

"This particular clinical trial is only for adults aged 18 to 85. Out of the 30 relevant studies, 898 are for people outside of this age range."

Answered by AI

Is this study widespread in Canada?

"Currently, this clinical trial is enrolling at 6 locations. They are situated in Las Vegas, Seattle, Scottsdale and additional cities. If you want to limit travel as a participating patient, please select the closest site to your location."

Answered by AI

Are there any presently open positions for volunteers in this experiment?

"According to the latest information on clinicaltrials.gov, this particular trial is not currently recruiting patients. This study was first posted on July 1st, 2018 and was updated June 13th, 2020. Although this trial isn't looking for volunteers right now, there are 911 other studies that are."

Answered by AI

Are there any specific prerequisites to joining this clinical trial?

"This clinical trial is enrolling 43 patients that have colorectal cancer and are between the ages of 18 and 85. To be eligible, participants must also meet the following requirements: an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; no prior chemotherapy for advanced or metastatic disease (though adjuvant chemotherapy or chemo-radiotherapy is allowed); no previous treatment with an mTOR inhibitor; and at least one measurable site of disease according to RECIST v1.1 that has not been previously irradiated. If the patient has had previous radiation to the marker"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer

2018. "Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03439462.