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Anti-metabolites

Mirvetuximab Soravtansine + Gemcitabine Hydrochloride for Ovarian, Breast, Fallopian Tube, Peritoneal, and Uterine Cancer

Phase 1
Waitlist Available
Led By Edward W Wang
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of two drugs, mirvetuximab soravtansine and gemcitabine hydrochloride, in treating patients with cancer that has come back. Mirvetuximab soravtansine is a monoclonal antibody linked to a chemotherapy drug, and gemcitabine hydrochloride is a chemotherapy drug.

Eligible Conditions
  • Breast Cancer
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Carcinoma
  • Uterine Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase II dose assessed by Common Terminology Criteria for Adverse Events version 4
Secondary outcome measures
Assessment of biological correlatives assessed by biopsy
Incidence of treatment-emergent adverse events and clinically significant >= grade 3 changes assessed by Common Terminology Criteria for Adverse Events version 4.0
Progression free survival
+1 more
Other outcome measures
FRalpha expression

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (IMGN853, gemcitabine hydrochloride)Experimental Treatment5 Interventions
Patients receive mirvetuximab soravtansine IV on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 3 weeks in the absence of disease progression or unexpected toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Mirvetuximab Soravtansine
2017
Completed Phase 3
~250
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,408 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,602 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Edward W WangPrincipal InvestigatorCity of Hope Medical Center

Media Library

Gemcitabine Hydrochloride (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02996825 — Phase 1
Breast Cancer Research Study Groups: Treatment (IMGN853, gemcitabine hydrochloride)
Breast Cancer Clinical Trial 2023: Gemcitabine Hydrochloride Highlights & Side Effects. Trial Name: NCT02996825 — Phase 1
Gemcitabine Hydrochloride (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02996825 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What additional research has been conducted regarding Pharmacological Study?

"Presently, there are 135 trials undergoing Phase 3 and 452 ongoing studies related to Pharmacological Study. Of the 24860 locations with clinical research on this subject, many of them exist in Woolloongabba, Queensland."

Answered by AI

What risks accompany Pharmacological Study for participants?

"The safety rating for this pharmacological study is 1 due to it being a Phase 1 trial, which presents minimal evidence in regards to both efficacy and security."

Answered by AI

What is the sample size of participants for this research program?

"Unfortunately, this research project is no longer accepting candidates; the trial was initially posted in March 2017 and last updated on June 7th 2022. Fortunately, if you look for other opportunities there are currently 5386 studies that target relapse cases as well as 452 trials looking to recruit participants into a Pharmacological Study."

Answered by AI

Are there any opportunities for enrolment in this clinical research?

"Unfortunately, this trial has ceased to recruit patients. Initially posted in March 2017 and recently modified on June 7th 2022, it is no longer an option for participation. However, there are currently 5386 studies involving relapse that remain open as well as 452 Pharmacological Studies still accepting applicants."

Answered by AI

In what ways is Pharmacological Study typically employed?

"Pharmacological Study is an effective intervention for small cell lung cancer (SCLC), head and neck carcinoma, as well as locally advanced pancreatic adenocarcinoma."

Answered by AI
~5 spots leftby Mar 2025