NCT03246074

Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Fostamatinib 100 mg bid and Paclitaxel	Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)
DRUG	Fostamatinib 150 mg bid and Paclitaxel	Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)
DRUG	Fostamatinib 200 mg bid and Paclitaxel	Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)

Timeline

• Start date: 2018-04-03
• Primary completion: 2022-08-09
• Completion: 2023-04-03
• First posted: 2017-08-11
• Last updated: 2024-10-24
• Results posted: 2024-09-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study