Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 2: testing Neoadjuvant chemotherapy for Gastric Adenocarcinoma
This is a single-center, randomly assigned, open-label clinical trial designed to measure the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy. Eligible patients will be randomly assigned to receive olanzapine 2.5 mg orally once daily (QD) in addition to standard neoadjuvant chemotherapy, beginning prior to initiation of chemotherapy and continuing until surgical resection.
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Neoadjuvant chemotherapy, or Olanzapine. The registry lists allocation as randomized. This is a single-center, randomly assigned, open-label clinical trial designed to measure the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy.
They plan to enroll about 26 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer
Primary outcome (registry wording): To evaluate weight change
Who it is for (from inclusion criteria)
Ages 18 Years to any
Age ≥ 18 years of age at time of consent
Eastern Cooperative Oncology Group (ECOG) score of 0-2
Histologically confirmed gastric adenocarcinoma, documented by biopsy
Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist
Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration
Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines
As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study
Who the registry excludes
Active infection requiring systemic therapy
Uncontrolled HIV/AIDS or active viral hepatitis
Pregnant or nursing
Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of this investigational regimen, as determined by the treating medical oncologist
Other major comorbidity, as determined by the study PI
Patients currently taking medications that may interact with olanzapine, including, but not limited to, other anti-psychotics, CNS depressants, or dopamine agonists
Patients with a clinically significant cardiac history or clinically significant QTc prolongation that, in the opinion of the treating investigator, would make olanzapine administration unsafe
This is a Phase 1/2, open-label, non-randomly assigned, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.
Objective: To follow people with GISTs and collect tumor tissue so that it can be studied in the lab. Eligibility: People age 6 and older who have a GIST.
This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07581405?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07581405?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.