Advanced Gastric Cancer. MedDRA version: 20.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: ASC-201
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: IRINOTECAN
CAS Number: 97682-44-5
Current Sponsor code: SPT1370
Other descriptive name: (+)-Irinotecan
Concentra
Sponsors
Ascelia Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if all of the following criteria apply: 1. Capable of giving signed informed consent as described in Appendix 2 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 2. Male or female patients must be =18 years of age, at the time of signing the informed consent. 3. Patients with histologically or cytologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma. 4. Are candidates for trifluridine/tipiracil therapy, having metastatic gastric gastroesophageal junction adenocarcinoma, who have been previously treated with at least two prior systemic treatment regimens for advanced disease. 5. Has measurable disease based on RECIST v.1.1 as determined by the site study team. Please see protocol v2.0 for full inclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 69 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: Patients are excluded from the study if any of the following criteria apply: 1. History of previous malignancy other than gastric cancer within the last 2 years except basal cell carcinoma or carcinoma in situ in solid organ. 2. Presence of chronic inflammatory bowel disease and/or bowel obstruction. 3. Homozygous for the uridine diphosphate glucuronosyltransferase (UGT1A1) *28 allele (Gilbert's syndrome) or otherwise known to have reduced UGT1A1 activity (applies for Phase 1 only). 4. Known central nervous system or brain metastases, unless previously treated and stable for 3 months. 5. Poorly controlled ascites and/or requirement for therapeutic paracentesis more frequently than once every 3 months. 6. Any other ongoing significant disease, or condition other than gastric cancer as judged by the Investigator to compromise the patients' ability to complete this study, eg but not limited to an active infection (including active hepatitis B, hepatitis C or HIV infections), unresolved pneumonia/pneumonitis, uncontrolled diabetes, poorly controlled hypertension or other cardiovascular disease. 7. Previously received irinotecan treatment for gastric cancer. 8. Receiving concomitant medication that are: (a) Strong inhibitors (eg, ketoconazole) of CYP3A4, OR (b) Strong inducers (eg, rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort) of CYP3A4, OR (c) Substrates of human thymidine kinase (eg, zidovudine). 9. Receiving any other investigational agent within 4 weeks prior to Screening. 10. Enrolled in another clinical study with an IMP. Please see protocol v2.0 for full exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: To assess the safety and tolerability of ASC-201 plus trifluridine/tipiracil when dosed concomitantly in patients with advanced gastric or gastroesophageal junction cancer. To determine the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of the combination. Phase 2: To evaluate the efficacy of ASC-201 plus trifluridine/tipiracil relative to placebo plus trifluridine/tipiracil by assessment of PFS in patients with advanced or metastatic gastric cancer.;Secondary Objective: Phase 1: To estimate the efficacy of ASC-201 plus trifluridine/tipiracil when dosed concomitantly by assessment of objective response rate (ORR), duration of response (DoR) for patients with measurable disease, and progression free survival (PFS) in all patients. Phase 2: To evaluate the efficacy of ASC-201 plus trifluridine/tipiracil relative to placebo plus trifluridine/tipiracil by assessment of overall survival (OS) in patients with advanced or metastatic gastric cancer.;Primary end point(s): Phase 1: Safety and tolerability will be evaluated in terms of dose limiting toxicities (DLTs), adverse events (AEs)/serious AEs (SAEs), vital signs, clinical chemistry/hematology parameters, and electrocardiogram (ECG) parameters. The measures of interest are patient incidence rates, absolute values, and change from baseline over time (AEs will be categorized by intensity using Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE v5.0]). Phase 2: Progression free survival is defined as the time from randomization until progression per RECIST v.1.1 as assessed by the Investigator or death due to any cause. The comparison will include all randomized patients, as randomized, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST v.1.1 progression. However, if the patient progresses or dies immediately after 2 or more consecutive missed visits, the patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Overall Survival is defined as time from randomization until the date of death due to any cause. The comparison will include all randomized patients, as randomized, regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy.;Secondary end point(s): Phase 1: Objective response rate is defined as the proportion of patients with measurable disease at baseline who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by the Investigator at the local site per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). Phase 2: Overall survival is defined as the time from randomization until the date of death due to any cause. The comparison will include all randomized patients, as randomized, regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy. Objective response rate is defined as the proportion of patients who have a CR or PR, as determined by the Investigator at the local site per RECIST v.1.1. Safety and tolerability will be evaluated in terms of AEs/SAEs, vital signs, clinical chemistry/ hematology, and ECG parameters. | — |
Countries
Belgium, France, Italy, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactMarie Källström
Ascelia Pharma AB
Outcome results
None listed