Table of contents
- Trial overview
- Trials in gynecologic cancers
- Trial in very high-risk T-cell acute lymphoblastic leukemia
- What researchers measure
- Who the trials are for
- Trial status and size
Trial overview
In the records provided, Granisetron appears in three Phase 2 interventional trials that study cancer treatment plans.[1][2][3] It is listed as one of several medicines used in the study treatment, rather than as the main drug being tested.[1][2][3]
The trials focus on different patient groups: people with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer; adults with recurrent or persistent uterine serous carcinoma; and patients with very high-risk T-lineage acute lymphoblastic leukemia (ALL).[1][2][3]
Trials in gynecologic cancers
Two trials study gynecologic cancer, which means cancer in the female reproductive organs.[1][3] One trial is in high-grade serous ovarian, fallopian tube, or primary peritoneal cancer, and the other is in recurrent or persistent uterine serous carcinoma.[1][3]
The ovarian cancer study, NCT05128825, is a Phase 2 interventional study with 253 planned participants and is authorised.[1] It studies azenosertib (also called ZN-c3 or KP-2638) and includes Granisetron among the listed medicines in the treatment plan.[1]
The uterine cancer study, NCT04814108, is a Phase 2 interventional study with 120 participants and is completed.[3] It studies azenosertib, also known as ZN-c3, and also lists Granisetron among the medicines used in the study.[3]
In both gynecologic cancer trials, the main goals are to look at safety and tolerability, which means how well patients handle treatment and what unwanted effects happen, and to measure antitumor activity, which means whether the treatment helps shrink or control the cancer.[1][3]
Trial in very high-risk T-cell acute lymphoblastic leukemia
The leukemia trial, NCT06253637, studies adults with very high-risk T-lineage acute lymphoblastic leukemia (ALL).[2] It is a Phase 2 interventional study with 31 planned participants and is authorised.[2]
This study tests daratumumab added to the national ALL treatment program, which includes chemotherapy and several support medicines, including Granisetron.[2] The study uses a pediatric-inspired treatment approach, meaning the treatment plan is based on a program designed for younger patients but applied here in adults with very high-risk disease.[2]
The main endpoint is MRD negativity after induction at time point 1 (TP1), with MRD meaning minimal residual disease, or very small amounts of leukemia that remain after treatment.[2] The study wants to see whether adding daratumumab improves the chance of reaching MRD negativity after the first induction cycle.[2]
What researchers measure
The ovarian cancer trial measures the frequency and severity of TEAEs, which are treatment-emergent adverse events, meaning health problems that start or get worse after treatment begins.[1] It also measures dose interruptions, dose reductions, and permanent discontinuations caused by related TEAEs, and it measures ORR, or overall response rate, using RECIST v1.1 and investigator review.[1]
The uterine cancer trial also measures TEAEs, including laboratory abnormalities, and it tracks dose interruptions, dose reductions, and permanent discontinuations caused by ZN-c3-related TEAEs.[3] Its main efficacy endpoint is ORR, assessed by independent central review using revised RECIST v1.1.[3]
The leukemia trial focuses on clinical response by checking whether patients become MRD negative after induction therapy.[2] This is a laboratory-based way to see how deeply the leukemia responds to treatment.[2]
Who the trials are for
These studies are aimed at patients with specific cancers, not at healthy volunteers.[1][2][3] The target groups are people with high-grade serous gynecologic cancers, adults with recurrent or persistent uterine serous carcinoma, and adults with very high-risk T-lineage ALL.[1][2][3]
Because each trial has different disease types and treatment goals, the entry rules are different for each study.[1][2][3]
Trial status and size
All three trials are Phase 2 studies, which means they are looking closely at treatment activity and safety in a defined patient group.[1][2][3]
One study is completed, and two are authorised.[1][2][3] The planned enrollment ranges from 31 patients in the leukemia study to 253 patients in the ovarian cancer study.[1][2][3]
These numbers show that the studies are focused and disease-specific, with each one designed to answer a different research question about the main cancer treatment plan that includes Granisetron.[1][2][3]
