AZD0901 for Stomach Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AstraZeneca
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
What data supports the idea that AZD0901 for Stomach Cancer is an effective drug?The available research does not provide specific data on the effectiveness of AZD0901 for Stomach Cancer. The studies mentioned focus on other treatments and methods for advanced gastric cancer, such as FOLFOX-4 chemotherapy and surgical methods, but do not mention AZD0901. Therefore, there is no direct evidence from the provided information to support the effectiveness of AZD0901 for this condition.156812
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, it is common for clinical trials to have specific requirements, so it's best to discuss your current medications with the trial team.
Is the drug AZD0901 a promising treatment for stomach cancer?The information provided does not directly mention AZD0901 or its effectiveness for stomach cancer. Therefore, based on the available data, we cannot determine if AZD0901 is a promising treatment for stomach cancer.79131415
What safety data is available for AZD0901 in stomach cancer treatment?The provided research does not contain any safety data for AZD0901 or its alternative names (CMG-901, CMG 901, CMG901) in the context of stomach cancer treatment. The studies mentioned focus on different drugs such as AZD8931, ZD9331, and AZD9291, none of which are related to AZD0901.2341011
Eligibility Criteria
This trial is for adults with advanced or metastatic stomach or gastroesophageal junction cancer that expresses a protein called Claudin18.2, who have already tried at least one other treatment. Participants should not be receiving other cancer treatments and must have adequate organ function.Treatment Details
The study tests the effectiveness and safety of AZD0901 against standard therapies chosen by the investigator, such as TAS-102, Docetaxel, Paclitaxel, Apatinib, Ramucirumab with Paclitaxel, or Irinotecan in patients with certain types of stomach cancers.
3Treatment groups
Experimental Treatment
Active Control
Group I: AZD0901 arm 1Experimental Treatment1 Intervention
Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.
Group II: AZD0901 Arm 2Experimental Treatment1 Intervention
Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment.
Group III: Investigator's choice armActive Control6 Interventions
Participants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Research SiteHollywood, FL
Research SiteCincinnati, OH
Research SiteLondon, Canada
Research SiteAnn Arbor, MI
More Trial Locations
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Who is running the clinical trial?
AstraZenecaLead Sponsor
References
[Evaluation of a novel adjuvant chemotherapy for non-resectable advanced gastric cancer]. [2014]To evaluate the effects of a novel adjuvant chemotherapy for the patients with advanced gastric cancer.
A phase II/III study comparing intravenous ZD9331 with gemcitabine in patients with pancreatic cancer. [2022]ZD9331 is a novel antifolate inhibitor of thymidylate synthase (TS). This multicentre, randomised, phase II/III study compared the efficacy and safety of ZD9331 with gemcitabine in 55 patients with chemonai;ve, locally advanced or metastatic pancreatic cancer. Patients received intravenous (i.v.) ZD9331 (n=30), on days 1 and 8 of a 3-week cycle or i.v. gemcitabine (n=25), once a week for 7 weeks followed by a 1-week rest, then on days 1, 8 and 15 of a 4-week cycle. Objective tumour response and clinical benefit response (CBR) were similar for both groups. More ZD9331 patients were alive at the data cut-off point compared with gemcitabine patients (13 and 8%, respectively). Median survival (152 versus 109 days, respectively) and time to progression (70 versus 58 days, respectively) were longer in the ZD9331 group. Nausea and vomiting (grade 1/2) were the most common toxicities in both groups. These results suggest that, in pancreatic cancer, ZD9331 is equivalent to gemcitabine and may offer a promising alternative to current therapies.
Phase II multicentre trial of ZD9331 monotherapy as first-line treatment for gastric cancer. [2019]ZD9331 is a novel, direct-acting and specific inhibitor of thymidylate synthase that has shown clinical activity and manageable tolerability in solid tumours. This phase II trial was designed to determine the antitumour activity and tolerability of ZD9331 given as a first-line therapy to patients with advanced gastric cancer.
Phase I trial of the antifolate ZD9331 in combination with cisplatin in patients with refractory solid malignancies. [2013]To determine the maximum tolerated dose and dose-limiting toxicities (DLTs) of ZD9331 in combination with cisplatin in patients with refractory solid tumors and to describe any preliminary antitumor activity associated with this regimen.
The survival impact of the intergroup 0116 trial on patients with gastric cancer. [2008]The Intergroup 0116 (INT 0116) trial demonstrated a survival benefit for a broad group of fully resected gastric cancer patients. This study examined the impact on survival of the release of this landmark trial.
Oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX-4) combination chemotherapy as a salvage treatment in advanced gastric cancer. [2022]This study was designed to determine the efficacy and safety of FOLFOX-4 chemotherapy as a salvage treatment for patients with advanced gastric cancer (AGC).
Retrospective analyses of cisplatin-based doublet combination chemotherapy in patients with advanced gastric cancer. [2021]Cisplatin-based chemotherapy, in combination with fluoropyrimidines or taxanes, have demonstrated efficacy against advanced gastric cancer (AGC). This retrospective study was performed with the data obtained from our cancer chemotherapy registry and eight another cancer centers.
[Clinical study on surgical method and prognosis in diffuse-type advanced gastric cancer]. [2018]To explore the prognosis and surgical method for diffuse-type advanced gastric cancer (AGC).
Comparison of Claudin 18.2 expression in primary tumors and lymph node metastases in Japanese patients with gastric adenocarcinoma. [2022]The monoclonal antibody zolbetuximab (formerly IMAB362), which is being developed as a potential treatment for gastric cancer (GC), targets Claudin 18.2 (CLDN18.2), a GC biomarker. This study aimed to determine the prevalence of CLDN18.2 in primary tumors and lymph node (LN) metastases of Japanese patients with GC.
Dual Erb B Inhibition in Oesophago-gastric Cancer (DEBIOC): A phase I dose escalating safety study and randomised dose expansion of AZD8931 in combination with oxaliplatin and capecitabine chemotherapy in patients with oesophagogastric adenocarcinoma. [2023]AZD8931 has equipotent activity against epidermal growth factor receptor, erbB2, and erbB3. Primary objectives were to determine the recommended phase II dose (RP2D) of AZD8931 + chemotherapy, and subsequently assess safety/preliminary clinical activity in patients with operable oesophagogastric cancer (OGC).
A natural anthraquinone derivative shikonin synergizes with AZD9291 against wtEGFR NSCLC cells through reactive oxygen species-mediated endoplasmic reticulum stress. [2022]NSCLC is the major type of lung cancer and the survival rates of NSCLC patients remain low. AZD9291 is a third-generation EGFR-TKI and approved to treat NSCLC patients harboring EGFR T790M mutation and common targetable activating EGFR mutations, but it has a limited effect for wtEGFR NSCLC.
Identification of Potential Core Genes Associated With the Progression of Stomach Adenocarcinoma Using Bioinformatic Analysis. [2022]Stomach adenocarcinoma (STAD) is one of the most frequently diagnosed cancer in the world with both high mortality and high metastatic capacity. Therefore, the present study aimed to investigate novel therapeutic targets and prognostic biomarkers that can be used for STAD treatment.
Clinical complete response after nivolumab administered as a third-line treatment for unresectable advanced gastric cancer with peritoneal dissemination: A case report. [2021]Nivolumab, which is a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, has been recommended as a third-line treatment based on the results of the ATTRACTION-2 study involving patients with unresectable advanced gastric cancer.
Randomized, open-label, phase 2 study of andecaliximab plus nivolumab versus nivolumab alone in advanced gastric cancer identifies biomarkers associated with survival. [2022]Matrix metalloproteinase-9 (MMP9) selectively cleaves extracellular matrix proteins contributing to tumor growth and an immunosuppressive microenvironment. This study evaluated andecaliximab (ADX), an inhibitor of MMP9, in combination with nivolumab (NIVO), for the treatment of advanced gastric cancer.
A Recombinant Human Adenovirus Type 5 (H101) Combined With Chemotherapy for Advanced Gastric Carcinoma: A Retrospective Cohort Study. [2022]This retrospective cohort study aimed to evaluate the clinical outcomes of H101 combined with chemotherapy for advanced gastric carcinoma (GC) patients.