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Anti-mitotic Agent

sorafenib tosylate for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

This trial is studying paclitaxel with or without sorafenib to see how well they work in treating patients with breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 2 trial • 20 Patients • NCT01502410

20%

Pain

10%

Lipase increased

10%

Hypoalbuminemia

10%

Respiratory, thoracic and mediastinal disorders - Other

10%

Anorexia

10%

Pericardial effusion

10%

Atelectasis

10%

Blood bilirubin increased

10%

Neutrophil count decreased

10%

Musculoskeletal and connective tissue disorder - Other

10%

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other

10%

Pleural effusion

10%

Rash maculo-papular

10%

Alkaline phosphatase increased

10%

Hypocalcemia

10%

Hypophosphatemia

10%

Back pain

10%

Diarrhea

10%

Neck pain

10%

Lung infection

100%

80%

60%

40%

20%

Study treatment Arm

Group 1 Relapsed/Refractory Rhabdomyosarcoma

Group 2 Relapsed/Refractory Wilms Tumor

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm IExperimental Treatment2 Interventions

Patients receive paclitaxel IV over 1 hour once weekly for 3 weeks. Patients also receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm IIActive Control2 Interventions

Patients receive paclitaxel as in arm I and oral placebo twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

FDA approved

Sorafenib

FDA approved

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