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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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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.
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My organs and bone marrow are functioning normally.
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I have a confirmed diagnosis of ovarian, fallopian tube, or peritoneal carcinoma.
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My blood pressure is controlled and ≤ 140/90 mmHg.
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I am HIV-positive, on effective treatment, and my viral load is undetectable.
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My hepatitis B is under control with medication that's allowed in this trial.
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My brain scans show no signs of cancer growth after treatment for brain metastases.
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I can provide a tumor sample before and after starting treatment, or I have a recent sample.
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I can take pills by mouth.
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I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.
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I can take care of myself but might not be able to do active work.
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I am a woman aged 18 or older.
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My heart function is classified as class 2B or better, despite my history of heart issues or treatments.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
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
555 Previous Clinical Trials
32,886 Total Patients Enrolled
2 Trials studying Ovarian Cancer
44 Patients Enrolled for Ovarian Cancer
Rigel PharmaceuticalsIndustry Sponsor
31 Previous Clinical Trials
3,826 Total Patients Enrolled
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)OTHER
47 Previous Clinical Trials
13,052 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

Frequently Asked Questions

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

To what extent has enrollment been successful for this clinical trial?

"Unfortunately, this clinical trial has concluded its recruitment process. It was initially uploaded on April 3rd 2018 and most recently updated the 8th of October 2022. Nevertheless, there are currently 677 studies enrolling patients with ovarian cancer and an additional 837 for Fostamatinib & Paclitaxel in search of participants."

Answered by AI

How are Fostamatinib and Paclitaxel typically administered for therapeutic purposes?

"Fostamatinib and Paclitaxel are normally used to combat neoplasm metastasis, but they can also be employed for alleviating Kaposi Sarcoma, advanced directives, and fallopian tubes carcinoma."

Answered by AI

To what extent have Fostamatinib and Paclitaxel been tested together in prior clinical studies?

"The first research of Fostamatinib and Paclitaxel was conducted back in 1997 at the City of Hope Comprehensive Cancer Center. Currently, there are 1175 completed clinical trials on record with 837 ongoing studies, many of which originate from Baltimore, Maryland."

Answered by AI

What potential risks are associated with Fostamatinib and Paclitaxel treatments?

"Our experts at Power graded the safety and efficacy of Fostamatinib with Paclitaxel to be a 1, as this is still an experimental phase. Therefore, there is limited supporting data available for both drug's effects."

Answered by AI

Are researchers still enrolling individuals into this research project?

"This trial has concluded its recruitment process. Initially published on April 3rd 2018, the study received its last update on August 10th 2022. However, if you are still searching for trials to participate in, there are 677 studies actively looking for ovarian cancer patients and 837 studies recruiting participants for Fostamatinib/Paclitaxel treatments."

Answered by AI

Is this research limited to individuals of a certain age, or can people under 35 years old join?

"According to the trial's entry requirements, successful applicants must be aged between 18 and 100. There are 48 trials specifically for those under 18 years of age and 1484 categories available for individuals over 65."

Answered by AI

What criteria is necessary for individuals to be eligible to join this research project?

"This research endeavour is in need of 27 individuals with ovarian cancer between the ages 18 and 100. Eligibility necessitates that patients present measurable disease according to RECIST v1.1; have relapsed within 6 months of last platinum-containing regimen or unable to proceed with more platinum therapy, possess normal organ and marrow function, maintained blood pressure ≤ 140/90 mmHg., not pregnant or planning on becoming pregnant during trial period - utilizing adequate contraception (hormonal or barrier method birth control; abstinence). Lastly, a Karnofsky ≥60% rating should be attained as per Appendix A standards."

Answered by AI
~4 spots leftby Mar 2025