Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer

Conditions

• Ovarian Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 3, 2018

Status verified

Oct 2024

Primary completion

Aug 9, 2022

Completion

Apr 3, 2023

Study Design

Enrollment

35 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Fostamatinib 100 mg bid and Paclitaxel
  Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle.
• Experimental: Fostamatinib 150 mg bid and Paclitaxel
  Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle.
• Experimental: Fostamatinib 200 mg bid and Paclitaxel
  Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle.

Primary Outcome Measure

Safety and Tolerability of Fostamatinib [ Time Frame: First cycle (28 days) of treatment ]

Locations (3)

Find similar trials in Washington D.C., DC

Related Studies

• Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado
• Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
  PHASE1/PHASE2 · Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland