DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of Sorafenib and Eribulin in Combination

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms

Intervention: Sorafenib (Nexavar, BAY43-9006) (Drug); Eribulin (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

This Phase 1 study will be conducted in an open-label, non-randomized, dose-escalation design in subjects with advanced, metastatic or refractory solid malignancy who are not candidates for standard therapy. The study drugs are sorafenib and eribulin mesylate. Up to 24 subjects with solid tumors will participate in the dose escalation part of the study, and once the maximum tolerated dose is defined, up to 30 subjects with advanced, metastatic or refractory solid tumors will participate in the expansion phase of the study. Eribulin (mesylate) will be administered intravenously at a fixed dose of 1. 4 mg/m2 on Days 1 and 8 of 21-day Cycles. The starting sorafenib dose (Dose Level 1) is 200 mg twice daily. Sorafenib is given orally, continuously on days 11 to 21 of Cycle 1, and from Day 1 to Day 21 of all subsequent cycles. If 200 mg sorafenib twice daily is tolerated with eribulin, the sorafenib dose will be escalated sequentially to 200 mg morning dose and 400 mg evening dose (Dose Level 2) in a new cohort. If Dose Level 2 is tolerated, a second dose escalation to 400 mg twice daily (Dose Level 3) will be studied in a new cohort. If the starting dose of sorafenib is not tolerated with eribulin, the sorafenib dose will be de-escalated to 200 mg once daily in a new cohort. Subjects will need to receive two cycles of eribulin plus sorafenib therapy and safety data for the first and second cycle needs to be available before the start of the next cohort.

Clinical Details

Official title: A Phase 1, Multi-center, Non-randomized, Open Label, Dose Escalation Design Study of Sorafenib (BAY43-9006) in Combination With Eribulin in Subjects With Advanced, Metastatic or Refractory Solid Tumors

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of participants with Adverse Events as a Measure of Safety and Tolerability

AUC (area under the plasma concentration vs time curve) of BAY43-9006

Cmax (maximum drug concentration in plasma after single dose administration) of BAY43-9006

QT time, assessed by QTcF / QTcB (QT interval corrected for heart rate according to Fridericia / Bazett)

Secondary outcome: Clinical benefit and response measured by RESIST (1.1) criteria

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with advanced, metastatic or refractory solid malignancy who are not

candidates for standard therapy. For subject with metastatic breast cancer, prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate bone marrow, cardiac, liver, renal and pancreatic function

- Predicted life expectancy of at least 12 weeks

Exclusion Criteria:

- Prolonged corrected QT (QTc), defined as QTcF (QT interval corrected for heart rate

according to Fridericia) interval > 450 msec at screening by central reader

- Cardiac disease: Congestive heart failure > NYHA Class II; subjects must not have

unstable angina (angina symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

- Arterial or venous thrombi, including cerebrovascular accident and myocardial

infarction in the past 6 months

- Pulmonary hemorrhage event ≥ CTCAE (common toxicity criteria for adverse events)

Grade 2 within 4 weeks

- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks

- Chemotherapy, hormonal therapy, investigational drugs, or radiotherapy within the

last 28 days and/or not recovered (< Grade 1) from prior therapy. Start of study treatment is allowed within less than 28 days of the prior therapy provided that 5 half-lives of the prior treatment drug(s) have elapsed.

- Use of medication that may prolong QTc

Locations and Contacts

Toulouse 31052, France

Berlin 10117, Germany

Freiburg, Baden-Württemberg 79106, Germany

Heidelberg, Baden-Württemberg 69120, Germany

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: July 2012
Last updated: July 28, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017