Vandetanib With Everolimus

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01582191
First received: April 18, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

The goal of this clinical research study is to find the highest tolerable dose of the combination of vandetanib and everolimus that can be given to patients with advanced cancer. The effects of the study drugs at different dose levels and the safety of the study drugs will also be studied.

Vandetanib and everolimus are both designed to harm cancer cells, stopping their growth. This may stop or slow the growth or spread of cancer cells.


Condition Intervention Phase
Advanced Cancers
Drug: Vandetanib
Drug: Everolimus
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of Vandetanib (a Multi-kinase Inhibitor of EGFR, VEGFR and RET Inhibitor) in Combination With Everolimus (an mTOR Inhibitor) in Advanced Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Vandetanib with Everolimus [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Maximum tolerated dose (MTD) defined as highest dose studied in which incidence of dose limiting toxicity (DLT) less than 33%. MTD defined by DLTs that occur in first 28-day cycle (induction phase).


Estimated Enrollment: 118
Study Start Date: May 2012
Estimated Primary Completion Date: May 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vandetanib + Everolimus

Starting dose of Vandetanib: 100 mg by mouth daily in a 28 day cycle.

Starting dose of Everolimus: 2.5 mg by mouth daily in a 28 day cycle.

Drug: Vandetanib
Starting Dose: 100 mg by mouth daily in a 28 day cycle.
Other Names:
  • ZD 6474
  • Zactima
  • Caprelsa
Drug: Everolimus
Starting dose: 2.5 mg by mouth daily of a 28 day cycle.
Other Names:
  • Afinitor
  • RAD001

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
  2. Patients must be at least 3 weeks beyond their previous cytotoxic chemotherapy. Patient must be at least 5 half-lives or 3 weeks, whichever is shorter, from their previous targeted or biologic therapy; In addition, patients must be at least 3 weeks beyond the last session of radiation therapy. Local palliative radiation therapy that is not delivered to all target lesions is allowed immediately before or during treatment.
  3. ECOG performance status should be less or equal to 3
  4. Patients must have organ and marrow function defined as: Absolute neutrophil count more or equal to 750/mL; platelets more or equal to 50,000/mL; creatinine less or equal to 3x ULN; total bilirubin less than or equal to 3.0.
  5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence).

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
  2. Pregnant or lactating women.
  3. History of hypersensitivity to vandetanib, lactose, murine products, or any component of the formulation.
  4. History of hypersensitivity to sirolimus, temsirolimus, everolimus.
  5. History of hypersensitivity to any component of the formulation.
  6. Patients unwilling or unable to sign informed consent document.
  7. Presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
  8. History (within the last 3 months) or presence of stroke/cerebrovascular accident.
  9. Congenital long QT syndrome.
  10. QTcF interval greater than 500 ms that is not correctable to less than 500ms such as with cessation of a causative medication, etc.
  11. History of myocardial infarction within 6 months with a residual arrhythmia that in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
  12. Presence of a symptomatic bradyarrhythmia or uncompensated heart failure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582191

Contacts
Contact: Vivek Subbiah, MD 713-563-0393

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Vivek Subbiah, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01582191     History of Changes
Other Study ID Numbers: 2011-0953, NCI-2012-00782
Study First Received: April 18, 2012
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Advanced solid cancer
Metastatic cancer
Vandetanib
ZD 6474
Zactima
Caprelsa
Everolimus
Afinitor
RAD001
Multi-kinase Inhibitor

Additional relevant MeSH terms:
Neoplasms
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on October 01, 2014