Relacorilant + Chemotherapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination treatment for individuals with metastatic pancreatic cancer, where the cancer has spread beyond the pancreas. The study examines the safety and effectiveness of relacorilant (an experimental treatment) combined with two chemotherapy drugs, nab-paclitaxel and gemcitabine. It targets those who have not yet received treatment for their metastatic cancer. Participants must have been diagnosed with metastatic pancreatic cancer within the last six weeks and should not have received previous systemic treatment for their metastatic disease. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does exclude those taking certain medications like corticosteroids and glucocorticoid receptor modulators. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of relacorilant with nab-paclitaxel and gemcitabine is under study to assess its safety for people. In earlier studies, some patients experienced tumor shrinkage or stable disease, suggesting potential effectiveness. However, understanding its safety remains crucial.
In one study, about 6.5% of patients had an unconfirmed partial response, indicating tumor reduction. Approximately 48.4% had stable disease, meaning their cancer did not progress. These results are promising but do not fully address the treatment's safety.
Understanding safety involves knowing how treatments are tested. This is a Phase 2 study, indicating that earlier tests deemed the treatment safe enough to proceed. This phase focuses on further evaluating safety and efficacy.
Prospective trial participants should discuss potential side effects with the study team. They can provide detailed safety information based on the latest research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about relacorilant combined with nab-paclitaxel and gemcitabine for pancreatic cancer because this trio has a unique approach. While standard treatments like gemcitabine and nab-paclitaxel target cancer cells directly, relacorilant is a selective glucocorticoid receptor modulator, which may enhance the effectiveness of chemotherapy by reducing cancer cell resistance. This combination could potentially improve outcomes by making cancer cells more susceptible to treatment, offering hope for better control of this aggressive cancer.
What evidence suggests that this treatment might be an effective treatment for pancreatic cancer?
In this trial, participants will receive a combination of relacorilant, nab-paclitaxel, and gemcitabine to treat advanced pancreatic cancer. Research has shown that using relacorilant with nab-paclitaxel and gemcitabine may aid in treating this condition. In one study, 35% of patients experienced smaller tumors, and 23% had a confirmed reduction in the size of their main tumor, indicating potential shrinkage. Another study found that some patients maintained stable disease, meaning their cancer did not worsen. These findings suggest that this combination could help manage and potentially slow the growth of pancreatic cancer.12346
Who Is on the Research Team?
Sachin Pai
Principal Investigator
Corcept Therapeutics
Are You a Good Fit for This Trial?
This trial is for patients with a recent diagnosis of metastatic pancreatic adenocarcinoma who haven't had previous systemic anticancer treatments. Participants must be able to swallow pills, have a life expectancy of at least 3 months, and show measurable tumor spread on scans. They should be in good enough health to perform daily activities with ease or minor difficulty.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive relacorilant in combination with nab-paclitaxel and gemcitabine in 28-day cycles until progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine
- Nab-paclitaxel
- Relacorilant
Trial Overview
The study tests the combination of relacorilant (150 mg daily), nab-paclitaxel (100 mg/m^2), and gemcitabine (1000 mg/m^2) in treating metastatic pancreatic cancer. It's a Phase 2 trial where all participants receive this treatment regimen to assess its safety and effectiveness.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The patient will receive relacorilant 150 mg, administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1, day -1), the day of, and the day after nab-paclitaxel and gemcitabine infusions. Nab-paclitaxel (100 mg/m\^2) and gemcitabine (1000 mg/m\^2) will be administered by IV infusion on Days 1, 8, and 15 of each 28-day cycle. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corcept Therapeutics
Lead Sponsor
Dr. Joseph K. Belanoff
Corcept Therapeutics
Chief Executive Officer since 2014
MD from Stanford University
Dr. William Guyer
Corcept Therapeutics
Chief Medical Officer since 2021
PharmD
Citations
Relacorilant plus nab-paclitaxel for the treatment of metastatic ...
Two (6.5%) patients attained unconfirmed partial responses and 15 (48.4%) had stable disease. Fourteen of 31 (45.2%) patients had reductions in ...
A study of relacorilant in combination with nab-paclitaxel ...
Relacorilant + nab-paclitaxel demonstrated antitumor activity with 15/43 (35%) patients showing decreases in target lesion size, 10/43 (23%) ...
Relacorilant With Nab-Paclitaxel and Gemcitabine in ...
This is a Phase 2, single-arm study to evaluate the safety and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in ...
NCT04329949 | Study of Relacorilant in Combination With ...
The goals of this study are to evaluate the efficacy, safety, and pharmacokinetics (PK) of relacorilant in combination with nab-paclitaxel in the treatment of ...
5.
onclive.com
onclive.com/view/dr-oberstein-on-data-for-pamrevlumab-plus-nab-paclitaxel-gemcitabine-in-pdacDr Oberstein on Data for Pamrevlumab Plus Nab ...
Confirmed objective response rates (ORR) were 26.1% in the concurrent nab-paclitaxel/gemcitabine arm and 35.3% in the pamrevlumab combination ...
Relacorilant With Nab-Paclitaxel and Gemcitabine in ...
Overall Survival (OS) · Best Overall Response (BOR) · Objective Response Rate (ORR) · Duration of Response (DoR) · Clinical Benefit Rate (CBR) · Cancer Antigen 19-9 ...
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