← Back to Search

Tyrosine Kinase Inhibitor

Fostamatinib + Paclitaxel for Ovarian Cancer

Phase 1
Waitlist Available
Led By Stephanie Gaillard, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have recurrent, platinum-resistant disease (defined as having relapsed within 6 months of last platinum-containing regimen) or be unable to receive further platinum therapy. There is no limit on the number of prior treatment regimens; however, patients may not have previously received weekly paclitaxel in the recurrent setting. Previous dose dense paclitaxel as initial therapy is allowable.
Patients must have normal organ and marrow function.
Must not have
Patients with Grade 2 or greater neuropathy.
Pregnant women are excluded from this study because the potential for teratogenic or abortifacient effects of fostamatinib are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with fostamatinib, breastfeeding should be discontinued if the mother is treated with fostamatinib. These potential risks may also apply to other agents used in this study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights

Summary

This trial is testing the safety of a combination of drugs for ovarian cancer patients.

Who is the study for?
This trial is for women over 18 with ovarian cancer that's resistant to platinum therapy or can't receive more of it. They must have normal organ/marrow function, measurable disease, and be able to take oral meds. Women who can get pregnant must use birth control during the study.
What is being tested?
The safety of combining Fostamatinib and Paclitaxel in different doses is being tested on people with ovarian cancer. The goal is to find the safest dose when these drugs are given together.
What are the potential side effects?
Possible side effects include allergic reactions similar to those from compounds like Fostamatinib or Paclitaxel, as well as risks associated with uncontrolled blood pressure and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer returned within 6 months after platinum treatment or I can't have more platinum therapy, and I haven't had weekly paclitaxel for it.
Select...
My organs and bone marrow are functioning normally.
Select...
I have a confirmed diagnosis of ovarian, fallopian tube, or peritoneal carcinoma.
Select...
My blood pressure is controlled and ≤ 140/90 mmHg.
Select...
My hepatitis B is under control with medication that's allowed in this trial.
Select...
I can take pills by mouth.
Select...
I can take care of myself but might not be able to do active work.
Select...
I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have moderate to severe nerve damage.
Select...
I am not pregnant or breastfeeding.
Select...
I do not have untreated brain metastases.
Select...
I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Drug metabolism determination
Response rate of treatment with combination therapy
Survival determination based on progression-free survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fostamatinib and PaclitaxelExperimental Treatment1 Intervention
Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose twice daily throughout each 28-day cycle. The dose of fostamatinib will be determined by the enrollment dose level. Given the mTPI design, dose-escalation decisions will be made based on the three dosing intervals, where the underdosing interval corresponds to dose escalation (E), overdosing interval corresponds to dose de-escalation (D), and proper dosing corresponds to staying at the current dose (S). The initial dose level will be Level 1 of Table 1. Participants will be individually continually assessed for DLT. The associated dose-escalation decisions are presented in Table 2. For illustration, suppose a cohort of 3 patients is at the current dose.

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
566 Previous Clinical Trials
33,349 Total Patients Enrolled
2 Trials studying Ovarian Cancer
44 Patients Enrolled for Ovarian Cancer
Rigel PharmaceuticalsIndustry Sponsor
33 Previous Clinical Trials
3,876 Total Patients Enrolled
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)OTHER
47 Previous Clinical Trials
12,927 Total Patients Enrolled

Media Library

Fostamatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03246074 — Phase 1
Ovarian Cancer Research Study Groups: Fostamatinib and Paclitaxel
Ovarian Cancer Clinical Trial 2023: Fostamatinib Highlights & Side Effects. Trial Name: NCT03246074 — Phase 1
Fostamatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03246074 — Phase 1
~4 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top