A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma

NCT05336266 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: IIT2021-16-HENDIFAR-KETOROCX
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if taking ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), is reasonable, safe and can stabilize or increase weight along with quality of life in pancreatic cancer patients.

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Pancreas Cancer

Keywords

ketorolac

Outcome Measures

Primary Outcomes (1)

• Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days.

  Defined as 75% or more of patients taking the study medication as prescribed for 5 days in a 6-day period: compliance diary.

  6 days

Secondary Outcomes (13)

• To describe the adverse events associated with ketorolac when administered.

  14 days

• Mean change in weight from baseline through the End-of-Study visit

  14 days

• Mean change in body fat from baseline through the End-of-Study visit

  14 days

• Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit

  14 days

• Evaluate change in physical function from baseline through the End-of Study visit

  14 days

Study Arms (1)

Ketorolac (open label)

EXPERIMENTAL

Pancreatic patients receiving Ketorolac four times a day for up to five days

Drug: Ketorolac Tromethamine

Interventions

Ketorolac Tromethamine DRUG

Trial treatment of ketorolac 10mg orally four times a day for 5 consecutive days

Ketorolac (open label)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of advanced and refractory pancreatic ductal adenocarcinoma (PDAC) referred to Cedars-Sinai Medical Center (CSMC).
• Cachexia defined as ≥5% weight loss in the presence of chronic illness, within any 6-month period prior to screening or as documented by the medical physician based on standard diagnosis of cachexia.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky performance status \>50%.
• Patient must have adequate renal function per below lab values:
• Creatinine OR measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN.
• Patient must have access to WiFi for the Smart Scale.

You may not qualify if:

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.
• Pregnancy, breastfeeding, or of childbearing potential and not willing to use adequate methods of contraception during the study.
• Has any known allergies or hypersensitivity to the study drug or allergic reactions to surgical steel or elastomer/rubber.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Concurrent use of any other NSAIDs while on study.
• Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding.
• Have suspected or confirmed cerebrovascular bleeding, tendency to bleed or bruise easily, incomplete hemostasis (how you body stops bleeding), and at high risk of bleeding.

Sponsors & Collaborators

• Andrew Hendifar, MD: lead
• Yinuoke Ltd.: collaborator

Study Sites (1)

Cedars- Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Andrew Hendifar, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Medicine

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 20, 2022
• Study Start: July 1, 2022
• Primary Completion: February 19, 2025
• Study Completion (Estimated): December 5, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

US (1)