Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Adenocarcinoma

Prostatic Neoplasms

Neuroendocrine Tumors

Carcinoma, Adenosquamous

Carcinoma, Islet Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Pancreatic Cancer

Pancreatic or gastrointestinal neuroendocrine neoplasms with Ki-67 \> 20%

Neuroendocrine prostate carcinoma with Ki-67 \> 20%

160 mg, PO, Once daily 5 days on and 2 days off

ESK981

Cancer AnswerLine

Vaibhav Sahai, MBBS, MS

Vaibhav Sahai

This protocol will enroll patients with pancreatic adenocarcinoma and adenosquamous carcinoma (Cohort 1), gastrointestinal/pancreatic neuroendocrine neoplasms with Ki-67 \> 20% (Cohort 2) and neuroendocrine prostate carcinoma (Cohort 3)). Each cohort will have its own interim analysis after enrollment of 10 patients.

Subjects will be given a one-month (28 day) supply of study drug (ESK981). Subjects will be instructed to take 4 capsules, with or without food, once per day for 5 consecutive calendar days, then take a drug holiday for 2 consecutive days before repeating the 5 days on-2 days off cycle in sets of 4 weeks or 28 calendar days. Subjects will be asked to keep a pill diary noting the date they take their study drug.

Multicenter Trial of ESK981 in Patients With Select Solid Tumors

A Phase II Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Determining efficacy using proportion of patients alive and progression-free at 4 months within each cancer subtype

The ORR will be assessed per RECIST v1.1 criteria (Cohort 1 and 2) or combined RECIST v1.1 + PCWG3 criteria (Cohort 3). Partial or complete response will require confirmation on repeat scan at least 4 weeks from initial radiologic response

DoR will be measured from the start date of the best response achieved until the date of relapse (i.e., progression). Continuing responders will be right-censored as of the most recent date on which their response status had been assessed. DoR applies to only the patients who achieve either a complete response or a partial response.

The OS will be defined from the date of treatment to either date of death or censoring and estimated using the product-limit method of Kaplan and Meier. Follow-up time will be censored at the date of last disease evaluation.

Adverse events (AEs) will be defined per the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v5.0.

The PFS will be defined as time from date of initial treatment to date of radiological or clinical progression (leading to withdrawal from the study treatment), or death from any cause on study treatment, whichever comes first. Follow-up time will be censored at the date of last disease evaluation.

University of Michigan Rogel Cancer Center

Antineoplastic Agents

All Drugs and Chemicals

Central Nervous System Depressants

Other Dietary Supplements

Capecitabine

Durvalumab

Oxaliplatin

Benzocaine

Antimetabolites

Antineoplastic Agents, Immunological

Tannic Acid

Durvalumab combined with XELOX chemotherapy as the first-line treatment

Combination therapy includes:

Durvalumab: intravenous infusion with a fixed dose of 1500 mg on day 1, repeated every 3 weeks ± 3 days; Chemotherapy: Oxaliplatin 130mg/m2 intravenous infusion on day 1, capecitabine 1000mg/m2, orally, twice a day, from day 1 to day 14; repeated every 3 weeks ± 3 days;

After 6 cycles of combination therapy, maintain with durvalumab 1500 mg every 4 weeks ± 3 days for 2 years. Terminate the trial if confirmed disease progression, initiation of other anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent or other reasons considered by the investigators.

Durvalumab and Chemotherapy(oxaliplatin and capecitabine)

Yuejuan Cheng, MD

Yuejuan Cheng

First-Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma - a prospective Single-arm Phase II Study \[NCT ID not yet assigned\]

A prospective Single-arm Phase II Study to evaluate the effectiveness and safety of the combination treatment of durvalumab with XELOX chemotherapy as the first-line in advanced gastrointestinal neuroendocrine carcinoma

First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma

First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Patients With Advanced Gastrointestinal Neuroendocrine Carcinoma: A Prospective Single-arm Phase II Study

The proportion of patients who achieved complete remission or partial remission due to tumor size reduction (according to RECIST 1.1 standard)

The proportion of patients whose tumor shrinks and achieve complete remission, partial remission or stable condition (according to RECIST 1.1 standard);

from the time of enrollment to the time of progression or death from any cause;

from the time of enrollment to the time of death;

the frequency and severity of all adverse events (Adverse Event, AE), the severity of adverse events is evaluated according to the CTC AE v5.0 standard

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multicenter Trial of ESK981 in Patients With Select Solid Tumors	NCT05988918	Pancreatic Aden... Adenosquamous C... Pancreatic Neur... Pancreatic Neur... Gastrointestina... Gastrointestina... Neuroendocrine ...	ESK981	18 Years -	University of Michigan Rogel Cancer Center
First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma	NCT06070740	Gastrointestina...	Durvalumab and ...	18 Years - 75 Years	Peking Union Medical College Hospital
First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma	NCT06070740	Gastrointestina...	Durvalumab and ...	18 Years - 75 Years	Peking Union Medical College Hospital
First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma	NCT06070740	Gastrointestina...	Durvalumab and ...	18 Years - 75 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for gastrointestinal neuroendocrine carcinoma