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Anti-metabolites
Gemcitabine + Nab-paclitaxel + IM156 for Pancreatic Cancer
Phase 1
Recruiting
Led By Shubham Pant, MD
Research Sponsored by M.D. Anderson Cancer Center
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 and or average of 1 year
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if it is safe and effective for treating pancreatic cancer.
Who is the study for?
This trial is for adults with advanced pancreatic cancer who haven't had treatment for metastatic disease. They must understand the study and agree to sign a consent form, have measurable disease, possibly be HIV-positive but with undetectable viral load, not be on certain medications or have serious health issues that could affect safety or compliance.Check my eligibility
What is being tested?
The study tests if IM156 added to gemcitabine and nab-paclitaxel is safe and improves treatment outcomes in patients with advanced pancreatic cancer. It's an early-phase trial to assess this combination's tolerability and potential effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation, typical chemotherapy-related issues like nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk or bleeding tendencies, nerve damage causing numbness or pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion and or average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion and or average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation Phase followed by a Dose Expansion PhaseExperimental Treatment3 Interventions
In the Dose Escalation Phase of the study, we will identify the RPD2 of IM156. Subsequently, we will evaluate IM156 at the RP2D (established in the Dose Expansion Phase) and gemcitabine + nab-paclitaxel in the Dose Expansion Phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IM156
2017
Completed Phase 1
~30
Nab paclitaxel
2014
Completed Phase 2
~70
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,321 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,829 Total Patients Enrolled
Shubham Pant, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
190 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I finished any previous cancer treatments at least 6 months ago.I have not received any treatment for my cancer since it spread.I have chronic hepatitis B but it's under control with medication.I haven't had a heart attack or blood clot in the arteries in the recent months.I am fully active or restricted in physically strenuous activity but can do light work.I am currently taking medication that is sensitive to CYP2D6.I haven't had serious stomach bleeding or issues affecting medicine absorption in the last 6 weeks.My organs and bone marrow are working well.I am being treated for diabetes with a medication that is not a biguanide.My cancer is a type of pancreatic cancer confirmed by lab tests.I agree to use contraception while on this trial.My last radiation therapy was over 14 days ago.I have another cancer that does not affect this treatment's safety or effectiveness.I had major surgery with general anesthesia over 4 weeks ago.I am a woman who can become pregnant and meet specific health criteria.I had hepatitis C but have been treated and cured.I do not have serious infections, bowel issues, or severe lung conditions.I am HIV-positive, on treatment, and my viral load is undetectable.I am not currently receiving any cancer treatments like chemotherapy or immunotherapy.I am not on long-term high-dose steroids or other drugs that weaken my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Phase followed by a Dose Expansion Phase
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.
Has the Food and Drug Administration greenlit IM156 as a viable treatment?
"Our experts at Power determined the safety of IM156 to be a 1, given that it is in its early stages and there is limited data supporting efficacy or safety."
Answered by AI
Is there an opportunity for participants to join this scientific investigation?
"As of late, clinicaltrials.gov possesses evidence that this medical trial is presently seeking participants. The initial posting date was on October 21st 2022 and the last revision occurred on the same day."
Answered by AI
How many participants are being monitored in this experiment?
"Yes, according to the information listed on clinicaltrials.gov, this study is currently searching for patients. The trial was initially uploaded on October 21st 2021 and has been updated as recently as October 21st 2022. 25 individuals are needed across 1 medical sites in order to complete recruitment."
Answered by AI
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