IDX-1197 + Chemotherapy for Stomach Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Idience Co., Ltd.
No Placebo Group
Trial Summary
What is the purpose of this trial?This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.
Do I have to stop taking my current medications for the trial?The trial requires that you stop using any cytochrome P3A4 inhibitors or inducers and strong UGT1A1 inhibitors. Other medications are not specifically mentioned, so consult with the trial team for more details.
Is the drug IDX-1197 combined with Irinotecan and XELOX a promising treatment for stomach cancer?Yes, the combination of IDX-1197 with Irinotecan and XELOX shows promise for treating stomach cancer. Irinotecan has shown positive results in treating various cancers, including gastric cancer, and XELOX is a known effective treatment for gastric cancer. This combination could potentially enhance treatment effectiveness.245810
What safety data exists for IDX-1197 + chemotherapy for stomach cancer?The safety data for the chemotherapy components of the treatment, such as irinotecan (Camptosar) and capecitabine/oxaliplatin (XELOX), indicate manageable toxicities and acceptable safety profiles in various cancer types, including gastric cancer. The combination of irinotecan and capecitabine has shown manageable toxicities in colorectal cancer, and a modified XELOX regimen has been evaluated for safety in advanced gastric cancer. However, specific safety data for IDX-1197 (Venadaparib, NOV1401) in combination with these chemotherapies for stomach cancer is not provided in the available research.136710
What data supports the idea that IDX-1197 + Chemotherapy for Stomach Cancer is an effective treatment?The available research shows that the combination of irinotecan and docetaxel has been evaluated for advanced gastric cancer, which is a type of stomach cancer. This study looked at patients who had already tried other treatments without success. The results indicated that this combination could be effective for these patients. However, there is no specific data provided about IDX-1197 in the context of stomach cancer, so we can't directly compare it to other treatments for this condition based on the information available.12359
Eligibility Criteria
This trial is for adults with advanced gastric cancer, including tumors at the gastroesophageal junction or upper stomach. Group 1 includes those who haven't had treatment before, while Group 2 has had two or more rounds of chemotherapy. Participants must be relatively healthy and active (ECOG ≤1) and have at least one measurable tumor. People with HIV, hepatitis B/C, heart issues, uncontrolled illnesses like diabetes or infections needing IV antibiotics can't join.Inclusion Criteria
I have advanced stomach cancer and have had at least 2 rounds of chemotherapy.
I am fully active or can carry out light work.
I have advanced or recurrent stomach cancer that has not been treated yet.
I have at least one tumor that can be measured or evaluated.
Exclusion Criteria
I have no ongoing major side effects from previous treatments.
My heart's electrical activity is abnormal, or I have a family history of long QT syndrome.
I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
My high blood pressure is not under control.
I do not have any uncontrolled illnesses like severe infections, diabetes, or liver, kidney, or lung diseases.
I am not taking any strong medication that affects liver enzymes.
I have had cancer spread to the lining of my brain and spinal cord.
I haven't had serious heart issues or surgeries in the last 6 months.
I have an active Hepatitis B or C infection.
I am HER2 positive.
I have symptoms from brain metastasis that are not under control.
I do not have active or symptomatic pneumonitis, nor a history of it requiring steroids.
Treatment Details
The study tests IDX-1197 in combination with either XELOX (a mix of capecitabine and oxaliplatin) or irinotecan to see how safe they are together and to find the best doses for treating advanced gastric cancer. It's an early-phase trial where everyone knows what treatment they're getting (open-label).
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Group II: Group 1Experimental Treatment1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
Emory University Winship Cancer InstituteAtlanta, GA
Hematology Oncology Clinic Baton Rouge / Sarah CannonBaton Rouge, LA
Cleveland ClinicCleveland, OH
Dana Farber Cancer InstituteBoston, MA
More Trial Locations
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Who is running the clinical trial?
Idience Co., Ltd.Lead Sponsor
References
Capecitabine/irinotecan in colorectal cancer: European early-phase data and planned trials. [2018]Capecitabine (Xeloda) and irinotecan (CPT-11, Camptosar) exhibit single-agent activity in colorectal cancer, have nonoverlapping major toxicities, and exhibit a synergistic effect in tumor xenograft models. European early-phase trials of the combination in patients with metastatic colorectal cancer indicate good response rates across doses tested and manageable toxicities, with available data supporting use of a regimen of oral capecitabine at 1,000 mg/m2 twice daily on days 1 to 14 plus IV irinotecan at 250 mg/m2 on day 1 every 21 days in this setting. The European Organisation for Research and Treatment of Cancer has planned a phase III trial (EORTC 40015) comparing this regimen of capecitabine/irinotecan with infusional fluorouracil (5-FU)/leucovorin plus irinotecan in approximately 700 patients with metastatic colorectal cancer. The QUASAR (Quick and Simple and Reliable) 2 adjuvant trial will compare 5-FU/leucovorin with capecitabine/irinotecan given over 6 months as adjuvant therapy in patients with stage II/III colorectal cancer. These trials will help define the roles of this combination in the treatment of colorectal cancer.
Biweekly docetaxel-irinotecan with filgrastim support in pretreated breast and non-small-cell lung cancer patients. A phase I study. [2018]Docetaxel (DTX) has been shown to be a very active drug in both breast cancer (BC) and non-small-cell lung cancer (NSCLC). Irinotecan (CPT-11) is also active in NSCLC, and has shown promising antitumor activity in pretreated BC. PURPOSE. To define the MTDs of these two drugs given together every other week with the use of filgrastim support in pretreated BC and NSCLC patients.
Irinotecan, epirubicin, and capecitabine in metastatic adenocarcinomas: preliminary results of a phase I study. [2018]The combination of irinotecan (Camptosar), epirubicin, and capecitabine (Xeloda) has shown an acceptable toxicity profile. In this open-label phase I study, irinotecan was administered IV at a fixed dose of 250 mg/m2 on day 1 in combination with capecitabine at a fixed dose of 1500 mg/m2 for days 2 to 7 and epirubicin starting at a dose of 40 mg/m2 and escalating by 10 mg/m2 in cohorts of three patients for those with metastatic adenocarcinomas. With the addition of granulocyte colony-stimulating factor (G-CSF [Neupogen]) to the regimen, patients received epirubicin at clinically relevant doses after dose-escalation. Results of the topoisomerase activity will be reported with the final results of this phase I study. The dose-limiting toxicity has not yet been reached. This combination regimen in patients with upper gastrointestinal malignancies and breast cancer will be investigated as part of phase II studies, once the dose-limiting toxicity is determined. The appropriate sequencing of the regimen to maximize clinical efficacy will also be determined.
Combination chemotherapy with irinotecan and cisplatin in pretreated patients with unresectable or recurrent gastric cancer. [2019]The combination of irinotecan (CPT-11) and cisplatin (CDDP) is an active regimen for metastatic gastric cancer in the first-line setting. The objective of this retrospective study was to clarify its efficacy and safety in patients with prior chemotherapy for advanced or recurrent gastric cancer.
A phase II study of irinotecan and docetaxel combination chemotherapy for patients with previously treated metastatic or recurrent advanced gastric cancer. [2018]Irinotecan (I) and docetaxel (D), each of which has a unique mechanism of action, were recently introduced in the treatment of patients with advanced gastric cancer (AGC). We have evaluated the efficacy and safety of the ID combination for AGC patients after failure of fluoropyrimidine- or platinum-based chemotherapy.
[Feasibility study on Xelox (capecitabine plus oxapliplatin) in the volumetric modulated arc therapy (VMAT)-based preoperative chemoradiotherapy for locally advanced rectal cancer]. [2020]To investigate the feasibility of Xelox(capecitabine plus oxaliplatin) in the volumetric modulated arc therapy(VMAT)-based preoperative chemoradiotherapy (CRT) for locally advanced rectal cancer(LARC).
Modified biweekly oxaliplatin and capecitabine for advanced gastric cancer: a retrospective analysis from a medical center. [2018]We modified 3-week XELOX regimen with oxaliplatin to 85 mg/m 2 on Day 1 and capecitabine 1000 mg/m 2 BID for 10 days every 14 days to be more practical in clinical practice for advanced gastric cancer. The aim of this retrospective analysis is to evaluate the safety profile and efficacy of the modified oxaliplatin plus capecitabine (XELOX) regimen as the first-line treatment for patients with advanced gastric cancer in a medical center in Taiwan.
Phase I/II study of a combination of capecitabine, cisplatin, and intraperitoneal docetaxel (XP ID) in advanced gastric cancer patients with peritoneal metastasis. [2018]This study was conducted to determine the recommended dose (RD) of intraperitoneal docetaxel (ID) in combination with systemic capecitabine and cisplatin (XP) and to evaluate its efficacy and safety at the RD in advanced gastric cancer (AGC) patients with peritoneal metastasis.
Phase I Study of Neoadjuvant Chemotherapy with Capecitabine and Oxaliplatin for Locally Advanced Gastric Cancer. [2022]To determine the recommended dose of neoadjuvant chemotherapy of combined capecitabine and oxalipatin (G-XELOX) for locally advanced gastric cancer.
Outcomes of a Phase II Study of Intraperitoneal Paclitaxel plus Systemic Capecitabine and Oxaliplatin (XELOX) for Gastric Cancer with Peritoneal Metastases. [2022]Adding intraperitoneal paclitaxel (IP-PTX) to paclitaxel/5-fluoropyrimidine has shown promising results in patients with gastric cancer peritoneal metastases (GCPM) but has not been studied with standard-of-care platinum/fluoropyrimidine combinations. Our goal to was evaluate IP-PTX with capecitabine/oxaliplatin (XELOX) in GCPM.