Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer

NCT01582191 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: 2011-0953NCI-2012-007820953
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of vandetanib and everolimus when given together in treating patients with cancer that has spread to other places in the body. Vandetanib and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

Advanced Malignant Neoplasm; Metastatic Malignant Neoplasm; Recurrent Malignant Neoplasm; Refractory Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities (DLT)

  DLT is defined as any clinically significant grade 3 or 4 non-hematologic toxicity as defined in the NCI-CTCAE v3.0, expected and believed to be related to the study medications, any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by NCI-CTCAE) or associated with bleeding and/or sepsis; Grade 3 to 4 thrombocytopenia lasting 7 days or thrombocytopenia associated with active bleeding or requiring platelet transfusion; Grade 3 nausea/vomiting lasting \> 48 hours or any Grade 4 nausea/vomiting despite maximum anti-nausea regimens (i.e. excluding Grade 3 nausea or Grade 3 to 4 vomiting or diarrhea in patients who had not received optimal antiemetic and anti-diarrheal treatment); and any other clinically significant Grade 3 non-hematologic toxicity including symptoms or signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complications or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.

  First 28-day cycle

Study Arms (1)

Treatment (vandetanib, everolimus)

EXPERIMENTAL

Patients receive vandetanib PO QD and everolimus PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Everolimus; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Vandetanib

Interventions

Everolimus DRUG

Given PO

Also known as: 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress

Treatment (vandetanib, everolimus)

Laboratory Biomarker Analysis OTHER

Optional correlative studies

Treatment (vandetanib, everolimus)

Pharmacological Study OTHER

Optional correlative studies

Treatment (vandetanib, everolimus)

Vandetanib DRUG

Given PO

Also known as: AZD6474, Caprelsa, Zactima, ZD-6474, ZD6474

Treatment (vandetanib, everolimus)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• ECOG performance status should be less or equal to 3
• 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.
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence).

You may not qualify if:

• Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
• Pregnant or lactating women.
• History of hypersensitivity to vandetanib, lactose, murine products, or any component of the formulation.
• History of hypersensitivity to sirolimus, temsirolimus, everolimus.
• History of hypersensitivity to any component of the formulation.
• Patients unwilling or unable to sign informed consent document.
• Presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
• History (within the last 3 months) or presence of stroke/cerebrovascular accident.
• Congenital long QT syndrome.
• QTcF interval greater than 500 ms that is not correctable to less than 500ms such as with cessation of a causative medication, etc.
• History of myocardial infarction within 6 months with a residual arrhythmia that in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
• Presence of a symptomatic bradyarrhthmia or uncompensated heart failure.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Subbiah V, Berry J, Roxas M, Guha-Thakurta N, Subbiah IM, Ali SM, McMahon C, Miller V, Cascone T, Pai S, Tang Z, Heymach JV. Systemic and CNS activity of the RET inhibitor vandetanib combined with the mTOR inhibitor everolimus in KIF5B-RET re-arranged non-small cell lung cancer with brain metastases. Lung Cancer. 2015 Jul;89(1):76-9. doi: 10.1016/j.lungcan.2015.04.004. Epub 2015 Apr 22.

  PMID: 25982012 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis; Recurrence; Neoplasms

Interventions

Everolimus; vandetanib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Sarina Anne Piha-Paul, MD
• Organization: The University of Texas MD Anderson Cancer Center

spihapau@mdanderson.org

(713) 563-1055

Study Officials

• Sarina Piha-Paul, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 20, 2012
• Study Start: May 14, 2012
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: August 28, 2026
• Results First Posted: August 28, 2026

Record last verified: 2026-08

Locations

US (1)