Sorafenib in Treating Patients With Advanced Malignant Solid Tumors

NCT00810394 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: UCDCC#213236614IST000375UCDCC-213
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to see how well it works in treating patients with advanced malignant solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Tolerating Re-escalated Dose of Sorafenib for 28 Days Without Dose Interruption or De-escalation for Toxicity

  Overall percentage of patients tolerating a dose escalation to 600 mg twice daily for 28 days plus the percentage tolerating a re-escalation to 400 mg twice daily in Cycle 3.

  At least 3 months

Secondary Outcomes (2)

• Overall Response Rate

  At least 3 months

• Time to Disease Progression

  Up to 2 years

Study Arms (1)

Sorafenib

EXPERIMENTAL

Dose Re-Escalation Following a Dose Reduction

Drug: Sorafenib

Interventions

Sorafenib DRUG

Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.

Also known as: Nexavar

Sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective or solid tumor for which sorafenib is considered acceptable therapy
• Age \> 18 years old
• Performance Status 0 - 2
• Measurable or non-measurable disease.
• Adequate bone marrow, liver and renal function
• Any number of prior chemotherapy regimens are allowed.
• Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy.
• Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
• Ability to understand and the willingness to sign a written informed consent.
• International normalized ratio \< 1.5 or a Prothrombin Time/Partial thromboplastin time within normal limits.

You may not qualify if:

• Prior therapy with sorafenib or sunitinib.
• Cardiac disease: Congestive heart failure \> class II New York Heart Association.
• Symptomatic or uncontrolled brain metastasis.
• No component of squamous carcinoma can be present in any patient with non-small cell lung cancer
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• Known HIV infection or chronic Hepatitis B or C.
• Active clinically serious infection \> CTCAE Grade 2.
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture.
• Evidence or history of bleeding diathesis or coagulopathy
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.
• Use of St. John's Wort or rifampin

Sponsors & Collaborators

• University of California, Davis: lead
• Bayer: collaborator

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Semrad TJ, Eddings C, Pan CX, Lau DH, Gandara D, Beckett L, Lara PN Jr. Feasibility study of intra-patient sorafenib dose-escalation or re-escalation in patients with previously treated advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):2001-7. doi: 10.1007/s10637-011-9761-y. Epub 2011 Oct 21.

  PMID: 22015991 RESULT

MeSH Terms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Analyst
• Organization: University of California Davis

pkaujla@ucdavis.edu

916 734 0294

Study Officials

• Primo N. Lara, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: January 10, 2018
• Results First Posted: March 10, 2017

Record last verified: 2017-03

Locations

US (1)