MM-398 and Ramucirumab in Treating Patients With Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT03739801|
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Unresectable Gastric Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Metastatic Unresectable Gastric Adenocarcinoma Unresectable Gastroesophageal Junction Adenocarcinoma Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma||Drug: Liposomal Irinotecan Other: Quality-of-Life Assessment Other: Questionnaire Administration Biological: Ramucirumab||Phase 1 Phase 2|
I. Phase I portion is to determine the recommended phase II dose (RP2D) of liposomal irinotecan (MM-398) when given in combination with ramucirumab at 8 mg/kg every 2 weeks in patients with gastric and gastroesophageal adenocarcinoma (GEAC) who had failed or are intolerant of platinum-based therapy.
II. Phase II portion is to assess the preliminary efficacy and tolerability of MM-398 in combination with ramucirumab in patients with GEAC who had failed or are intolerant of platinum based therapy.
I. To estimate the best overall response rate through up to three cycles of therapy among patients with measurable disease at study entry.
II. To assess the incidence and severity of toxicity of the combination.
I. Descriptive of quality of life domains using Patient-Reported Outcomes Measurement Information System (PROMIS) global health instrument (PRO).
II. Descriptive of altered genes on liquid biopsies. III. To assess the effect of the anti-angiogenic ramucirumab on distribution of MM-398 via magnetic resonance imaging (MRI) with and without ferumoxytol.
OUTLINE: This is a phase I, dose escalation study of MM-398followed by a phase II study.
Patients receive ramucirumab intravenously (IV) over 30 minutes and MM-398 IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of MM-398 in Combination With Ramucirumab After Platinum Failure in Gastric Cancer|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Treatment (ramucirumab, liposomal irinotecan[MM-398])
Patients receive ramucirumab IV over 30 minutes and MM-398 IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Liposomal Irinotecan
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Dose limiting toxicity (DLT) (Phase I) [ Time Frame: Up to 28 days ]DLT is defined as follows: For hematological toxicity: Drug-related grade 4 neutropenia for more than 5 days without fever or infection; Grade 4 neutropenia of any duration accompanied by fever or infection, Grade 4 thrombocytopenia. For non-hematological toxicity: All grade 3-4 that represents a 2 grade increase over baseline, excluding: Untreated or inadequately treated nausea, vomiting, diarrhea lasting shorter than 24 hours; Alopecia; Grade 3 fatigue that returns to grade 2 or less within 7 days; Grade 3 laboratory abnormalities that are not considered clinically significant and that return to grade 2 or less within 72 hours.
- Progression-free survival (PFS) (Phase II) [ Time Frame: Up to 6 months ]PFS will be calculated from treatment start date to date of disease progression or date of death due to any cause, or to the time of last follow-up, whichever occurs first.
- Best overall response (BOR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria [ Time Frame: Up to 6 months ]BOR will be evaluated from start of treatment until progression/recurrence.
- Incidence of adverse events graded according to CTCAE version 4.0 [ Time Frame: Up to 6 months ]Analyses of safety/toxicity will be performed for all patients having received at least one dose of study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739801
|Contact: Charlean Ketchens, RN||323-865-3035||Charlean.Ketchens@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Not yet recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Afsaneh Barzi 323-865-3829 firstname.lastname@example.org|
|Principal Investigator: Afsaneh Barzi|
|Principal Investigator:||Afsaneh Barzi, MD||University of Southern California|