A Study of RAD001 and Sunitinib in Metastatic Renal Cell Carcinoma

NCT00422344 | Completed Phase 1

• 1 other identifier: 06-105
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety of RAD-001 and Sunitinib given in combination for renal cell cancer. We also want to find out what effects (good and bad) the combination of RAD-001 and Sunitinib have on you and your tumor. RAD001 is a pill that works by shutting down some of the pathways in the cell that make tumors grow. Sunitinib is a pill that works by shutting off the signal in the cancer cells that tell the cells to grow blood vessels. Without this signal, the blood vessels to the tumors shrink down.

Conditions

Renal Cell Carcinoma; Kidney Cancer

Keywords

RAD001; Sunitinib; renal; kidney

Outcome Measures

Primary Outcomes (1)

• To assess the maximum tolerated doses and overall safety and tolerability of Sunitinib administered in combination with RAD001 for the treatment of patients with metastatic renal cell carcinoma.

  toxicities observed in Cycle 1 - a cycle is defined by Sunitinib dosing ( 6 weeks)

Secondary Outcomes (1)

• To assess antitumor activity of the combination of Sunitinib and RAD001.

  conclusion of this study

Study Arms (1)

RAD001 AND SUNITINIB

EXPERIMENTAL

RAD001 AND SUNITINIB IN METASTATIC RENAL CELL CARCINOMA PATIENTS

Drug: RAD001, Sunitinib

Interventions

RAD001, Sunitinib DRUG

Patients will start treatment with Sunitinib and RAD001 on Cycle 1, Day 1. Sunitinib will be given orally daily for 4 weeks followed by a 2 week rest period. RAD001 will be given orally daily or weekly in subsequent cohorts with the first treatment on day 1. DLT determination will be based on toxicities observed in Cycles 1 - a cycle being defined by Sunitinib dosing. Once the MTD for the combination has been identified, a total of 10 patients will be enrolled into the study at the highest dose level that allows for administration of multiple cycles and provides potentially therapeutic drug levels of both drugs

RAD001 AND SUNITINIB

Eligibility Criteria

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

You may qualify if:

• Any histologically confirmed renal cell carcinoma with metastases. Patients with unresected primary tumors may be enrolled as long as evidence of metastatic disease is also present.
• No prior sunitinib or m-TOR inhibitor. The washout period must be at least 4 weeks for any prior therapy.
• Male or female, 18 years of age or older.
• ECOG performance status 0 or 1.
• Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade less than or equal to 1.
• Adequate organ function as defined by the following criteria:
• Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) less than or equal to 2.5 x upper limit of normal (ULN) or less than 5 x ULN in the presence of liver metastases.
• Total serum bilirubin less than or equal to 1.5 mg/dL
• Total leukocyte count greater to or equal to 3000 cells/ul
• Absolute neutrophil count (ANC) greater than or equal to 1500/µL
• Platelets greater than or equal to 100,000/µL
• Hemoglobin greater than or equal to 9.0 g/dL
• Serum calcium less than or equal to 12.0 mg/dL
• Serum creatinine less than or equal to 2.0 x ULN
• PT less than or equal to 1.5 ULN

You may not qualify if:

• Major surgery, open biopsy, traumatic injury, radiation or systemic therapy within 4 weeks of starting the study treatment. Anticipation of major surgical procedure during the study. Prior palliative radiotherapy to metastatic lesion(s)is permitted, provided there is at least one measurable lesion that has not been irradiated.
• More than 3 prior systemic therapies for metastatic RCC.
• Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0.
• No other approved or investigational anticancer treatment will be permitted during the study period, including chemotherapy, biological response modifiers, hormone therapy, or immunotherapy, with the exception of palliative radiation therapy. No other investigational drug may be used during treatment on this protocol, and concurrent participation in another clinical trial is not allowed.
• NCI CTCAE grade 3 hemorrhage within the past 1 month.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
• Chronic treatment with systemic steroids or other immunosuppressive agent
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of Sunitinib or RAD001 (e.g. malabsorptive disorder, ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or small bowel resection)
• Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin)
• Current spinal cord compression, or carcinomatous meningitis.
• Any of the following within the 12 months prior to study drug administration:
• severe/unstable angina,
• MI,
• CABG,

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Novartis: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center 1275 York Avenue

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Everolimus; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Glenn Kroog, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 15, 2007
• Study Start: October 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 26, 2010

Record last verified: 2010-02

Locations

US (1)