Gastric Adenocarcinoma Clinical Trial
Official title:
An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard
administration dose and schedule. This application is a non-labeled indication for
cabazitaxel and will inform future drug development in gastroesophageal malignancies, where
docetaxel remains an approved first line agent, but is not routinely used due to excessive
toxicity and marginal efficacy.
At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel
in refractory gastric cancer, with preferential activity in one or more gastric cancer
subtypes
Prior to initiating protocol therapy, patients will undergo screening evaluations, to be done
within 30 days of protocol initiation unless otherwise noted.
Patients who are taxane naïve will be assigned to arm A and patients who have had prior
taxane therapy will be assigned to Arm B. Each arm will be analyzed separately for the
primary study endpoint of 3 month progression free survival rate (PFS), as defined as the
time from the start of treatment to the date of disease progression or death. Cabazitaxel
will be administered 20 mg/m2 IV over 1 hour every 3 weeks.
In the absence of treatment delays due to adverse event(s), treatment may continue until
disease progression; intercurrent illness that prevents further administration of treatment;
unacceptable adverse event(s); patient decides to withdraw; general or specific changes in
the patient's condition render the patient unacceptable for further treatment in the judgment
of the investigator.
Patients will be followed for 6 months after removal from study or until death, whichever
occurs first. Patients removed from study for unacceptable adverse events will be followed
until resolution or stabilization of the adverse event.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05977998 -
A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
|
Phase 2 | |
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Recruiting |
NCT03257163 -
Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer
|
Phase 2 | |
Completed |
NCT02128243 -
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
|
Phase 2 | |
Completed |
NCT01178944 -
Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
|
Phase 2 | |
Terminated |
NCT00209079 -
Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma
|
Phase 2 | |
Terminated |
NCT02862535 -
Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma
|
Phase 1 | |
Active, not recruiting |
NCT05008783 -
A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma
|
Phase 3 | |
Recruiting |
NCT04430738 -
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
|
Phase 1/Phase 2 | |
Recruiting |
NCT04114136 -
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
|
Phase 2 | |
Completed |
NCT03196232 -
Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer
|
Phase 2 | |
Recruiting |
NCT04047953 -
Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
|
N/A | |
Completed |
NCT02891447 -
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer
|
Phase 2 | |
Completed |
NCT02864381 -
Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
|
Phase 2 | |
Terminated |
NCT04032704 -
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT04604132 -
Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
|
Phase 1/Phase 2 | |
Completed |
NCT02830594 -
Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer
|
Phase 2 | |
Recruiting |
NCT06038578 -
A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
|
Phase 2 | |
Terminated |
NCT04099277 -
A Study of LY3435151 in Participants With Solid Tumors
|
Phase 1 |