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Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer

Phase I Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer

NCT03246074•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Summary

This research is being done to test the safety of the combination of the study drugs fostamatinib and paclitaxel. This study tests different doses of the drugs to see which doses are safest in people with ovarian cancer when given together.

Detailed Description

This is a phase I, open-label, non-randomized multicenter dose-escalation study with the primary objective to determine the maximally tolerated dose (MTD) of fostamatinib when administered with weekly paclitaxel in women with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Between 8 and 18 adult female subjects will be enrolled and receive weekly paclitaxel in combination with increasing doses of fostamatinib. There will be three dosing regimens of fostamatinib (100 mg bid, 150 mg bid, and 200mg bid) selected based on the FDA approved doses and prior phase I studies of single agent fostamatinib. Dose-escalation will follow a modified toxicity probability interval (mTPI) design. In this study, up to 18 adult female subjects will be enrolled and receive weekly paclitaxel in combination with fostamatinib at the MTD of the combination; at least 6 patients will receive fostamatinib plus paclitaxel at the MTD. A total of up to 30 patients will be enrolled in this study.

Eligibility

Age

18 - 100 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patients must have histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation (via the pathology report) of the original primary tumor is required.
•2. Patients must have measurable disease, according to RECIST v1.1.
•3. 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.
•4. Patients must have the ability to take oral medications.
•5. Females, age ≥18 years.
•6. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
•7. Life expectancy of greater than 3 months.
•8. Patients must have normal organ and marrow function.
•9. Patients with a diagnosis of hypertension are required to have adequate blood pressure control prior to enrollment, defined as blood pressure ≤ 140/90 mmHg.
•10. The effects of fostamatinib on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
+8 more criteria

Exclusion Criteria

•1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration.
•2. Patients who have not recovered (CTCAE v4.03 grade ≤1) from adverse events due to agents administered more than 4 weeks earlier, unless those events are deemed to have returned to baseline, are irreversible, or are unlikely to develop into a life-threatening condition at the permission of the Protocol Chair (e.g., alopecia).
•3. Patients who are currently receiving or have previously received any other investigational agents within 3 weeks prior to entering the study.
•4. Patients with known untreated brain metastases, as progressive neurologic dysfunction may develop that would confound the evaluation of neurologic and other adverse events.
•5. Patients with Grade 2 or greater neuropathy.
•6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to fostamatinib or paclitaxel. Patients who are able to tolerate paclitaxel on a desensitization protocol will be allowed.
•7. Strong CYP3A4 inhibitors or inducers should not be used within 3 days of Day 1 dosing until the end of study. Moderate CYP3A4 inhibitors or inducers should be used with caution.
•8. Uncontrolled intercurrent illness
•9. 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.

Locations (3)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 3, 2018

Primary Completion Date

August 9, 2022

Completion Date

April 3, 2023

Last Updated

October 24, 2024

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

Fostamatinib 100 mg bid and Paclitaxel

DRUG

Fostamatinib 150 mg bid and Paclitaxel

DRUG

Fostamatinib 200 mg bid and Paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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