A Phase I Trial of Bortezomib and Sunitinib

NCT00720148 | Completed Phase 1

• 2 other identifiers: IRB000035493549
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effect of the combination of sunitinib and bortezomib. We will see what effects it has on your cancer and find the highest dose of each agent that can be given without causing severe side effects.

Conditions

Solid Tumors

Keywords

Solid tumors

Outcome Measures

Primary Outcomes (1)

• Safety and toxicity of combination therapy with sunitinib and bortezomib

  every week

Secondary Outcomes (1)

• Tumor shrinkage

  every 6 weeks while on treatment

Interventions

Sunitinib and Bortezomib DRUG

50 mg/m2, IV (in the vein)on day 5 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops

Also known as: Sutent, Velcade

Eligibility Criteria

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

You may qualify if:

• Refractory advanced solid tumor that has failed standard therapy.
• ECOG PS ≤ 2
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• Male subject agrees to use an acceptable method for contraception for the duration of the study.
• Cardiac ejection fraction is more than 45%

You may not qualify if:

• Patient has a platelet count of \<100 x 109/L within 14 days before enrollment.
• Patient has an absolute neutrophil count of ANC \<1.0 x 109/L within 14 days before enrollment.
• Patient has a calculated or measured creatinine clearance of \<30 mL/minute within 14 days before enrollment.
• AST, ALT, total bilirubin \> twice the upper limits of normal.
• Received radiation to more than 30% of marrow volume
• Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment.
• Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
• Patient has hypersensitivity to sunitinib, bortezomib, boron or mannitol.
• Uncontrolled hypertension
• History of venous thromboembolic events.
• Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• Patient has received other investigational drugs with 14 days before enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Hemorrhagic tendency of the tumor

Sponsors & Collaborators

• Emory University: lead
• Millennium Pharmaceuticals, Inc.: collaborator
• Pfizer: collaborator

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Sunitinib; Bortezomib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines

Study Officials

• John Kauh, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

US (1)