Pancreas CancerEarly Phase 1KetoROCXNCT05336266
A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
A Early Phase 1 study testing Ketorolac Tromethamine in people with Pancreas Cancer and Pancreatic Ductal Adenocarcinoma, run by Andrew Hendifar, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer
- What is being tested?
- Ketorolac Tromethamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 5 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars- Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: IIT2021-16-Hendifar-KetoROCX: A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
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.
Read the detailed description
The main things that will happen in this study are: patients will be administered ketorolac for 5 days, blood draws, completion of questionnaires, monitoring physical activity and sleep by wearing a study-provided FitBit along with weight using a study-provided smart scale.
- Being tested
- Ketorolac Tromethamine
- Keywords
- ketorolac
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Trial treatment of ketorolac 10mg orally four times a day for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac (open label) | Experimental | Pancreatic patients receiving Ketorolac four times a day for up to five days Receives: Drug: Ketorolac Tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days
Secondary outcomes (13)
To describe the adverse events associated with ketorolac when administered.
-Safety is defined as stable or decreased number of adverse events (AEs) compared to published trials for the same chemotherapy.
Measured: 14 days
Mean change in weight from baseline through the End-of-Study visit
-Body weight stability is defined as weight change < 0.1kg/baseline Body Mass Index-unit from Baseline (start of 1 week lead-in prior to Day 1) to Day 6. Weight will be measured using the Aria Smart Scale. Changes in weight from Day 6 to Day 14 and from Day 1 to Day 14 will also be evaluated long term.
Measured: 14 days
Mean change in body fat from baseline through the End-of-Study visit
-Body fat percentage will be measured using the Aria smart scale and compared from Baseline (start of 1 week lead-in prior to Day 1) to Day 6. Changes in body fat percentage from Day 6 to Day 14 and from Day 1 to Day 14 will also be evaluated long term. An increase in body fat percentage will be regarded as a positive outcome.
Measured: 14 days
Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit
- Mean change in reported pain, sleep disturbance, and mood (anxiety/depression) using the NIH PROMIS-29 profile v2.1.
- The PROMIS-29 profile v2.1 questionnaire consists of 29 questions that ask the subject to rate : 1) how easy it is to perform routine tasks, 2) how mood impacts daily living, 3) quality of sleep, 4) feelings of fatigue, and 5) pain and how it impacts daily living. Each question is answered on a scale of 1-5, where higher scores indicate the most impact or severity. The questionnaire responses at baseline, end of treatment and end of study will be compared.
Measured: 14 days
Evaluate change in physical function from baseline through the End-of Study visit
- Mean change in reported physical function using the National Institute of Health (NIH) PROMIS Health Organization and PROMIS Cooperative Group questionnaire v2.0.
- The NIH PROMIS Scale consists of 165 questions that ask the subject to rate their physical function. Each question is answered on a scale of 1-5 where higher scores indicate the lowest level of difficulty. The questionnaire responses at baseline, end of treatment and end of study will be compared.
Measured: 14 days
Mean change in daily activity (step taken) from baseline
As measured by continuous daily wearable activity monitor
Measured: 14 days
Mean change in average heart rate from baseline
As measured by continuous daily wearable activity monitor
Measured: 14 days
Mean change in peak heart rate from baseline
As measured by continuous daily wearable activity monitor
Measured: 14 days
Mean change in sleep duration from baseline
As measured by continuous daily wearable activity monitor
Measured: 14 days
Mean change in sleep disturbances from baseline
As measured by continuous daily wearable activity monitor
Measured: 14 days
Mean change in daily active minutes from baseline
As measured by continuous daily wearable activity monitor
Measured: 14 days
Decrease in inflammatory biomarkers (CA-19 and CRP) from baseline
CA-19 and CRP lab results from baseline will be compared to results from Day 6
Measured: 6 days
Mean change in calories consumed from baseline through the End-of-Treatment visit
As measured by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool. The ASA is a system to collect 24-hour food recalls and provide complete nutrient analysis of the foods and beverages consumed during the collection timeframe. The tool is used in this study to calculate total calories consumed.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jul 2022
- Primary completion19 Feb 2025
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Hendifar, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Yinuoke Ltd.
- Responsible party
- Sponsor-investigator, Andrew Hendifar, MD, Cedars-Sinai Medical Center
- Investigators
- Andrew Hendifar, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336266
- Sponsor's protocol ID
- IIT2021-16-HENDIFAR-KETOROCX
- Acronym
- KetoROCX
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2021-16-Hendifar-KetoROCX: A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05336266
- Acronym / sponsor ID
- KetoROCX / IIT2021-16-HENDIFAR-KETOROCX
- Keywords
- ketorolac
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Andrew Hendifar, MDUniversity, hospital or other
- Collaborators
- Yinuoke Ltd.
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main things that will happen in this study are: patients will be administered ketorolac for 5 days, blood draws, completion of questionnaires, monitoring physical activity and sleep by wearing a study-provided FitBit along with weight using a study-provided smart scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketorolac (open label) | Experimental | Drug: Ketorolac TromethaminePancreatic patients receiving Ketorolac four times a day for up to five days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Patient must have access to WiFi for the Smart Scale.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac TromethamineTrial treatment of ketorolac 10mg orally four times a day for 5 consecutive days | Drug | Ketorolac (open label) |
Primary outcome
Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days.
Time frame: 6 days
Defined as 75% or more of patients taking the study medication as prescribed for 5 days in a 6-day period: compliance diary.
13 secondary outcomes
To describe the adverse events associated with ketorolac when administered.
Time frame: 14 days
Mean change in weight from baseline through the End-of-Study visit
Time frame: 14 days
Mean change in body fat from baseline through the End-of-Study visit
Time frame: 14 days
Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit
Time frame: 14 days
Evaluate change in physical function from baseline through the End-of Study visit
Time frame: 14 days
Mean change in daily activity (step taken) from baseline
Time frame: 14 days
Mean change in average heart rate from baseline
Time frame: 14 days
Mean change in peak heart rate from baseline
Time frame: 14 days
Mean change in sleep duration from baseline
Time frame: 14 days
Mean change in sleep disturbances from baseline
Time frame: 14 days
Mean change in daily active minutes from baseline
Time frame: 14 days
Decrease in inflammatory biomarkers (CA-19 and CRP) from baseline
Time frame: 6 days
Mean change in calories consumed from baseline through the End-of-Treatment visit
Time frame: 6 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Hendifar, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketorolac Tromethamine in people with Pancreas Cancer and Pancreatic Ductal Adenocarcinoma, run by Andrew Hendifar, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days. (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.