Sorafenib and RAD001 Renal Cell Carcinoma

NCT00384969 | Completed Phase 1 DMC

• 1 other identifier: UCSF06523
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the phase I part of the study is to determine the maximum tolerated dose and dose limiting toxicities of the combination of RAD001 and sorafenib in patients with untreated metastatic kidney cancer.

Conditions

Renal Cell Carcinoma

Keywords

RAD001; Sorafenib; Renal Cell Carcinoma; Metastatic

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  weekly

Secondary Outcomes (1)

• Objective response rate

  8 weeks

Study Arms (1)

1

EXPERIMENTAL

RAD001 and Sorafenib

Drug: RAD001 and Sorafenib

Interventions

RAD001 and Sorafenib DRUG

RAD001 2.5mg to 10.0mg PO QD Sorafenib 400mg PO BID

1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically- or cytologically-confirmed renal cell carcinoma containing predominant (\>50%) clear cell histology, which is metastatic or unresectable
• Cytoreductive nephrectomy is allowed
• Evidence of RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan)
• Male or female at least 21 years old
• ECOG performance status 0-1
• Adequate bone marrow function:
• ANC ≥ 1500/uL
• platelet count ≥ 100,000/uL
• hemoglobin ≥ 9.0 g/dL
• Adequate hepatic function:
• Total bilirubin ≤ 1.5 X ULN
• AST (SGOT) ≤ 2.5 X ULN
• ALT (SGPT) ≤ 2.5 X ULN
• Adequate renal function as determined by either:
• Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used) Modified Cockcroft-Gault formula: ((140 - age(yrs)) x (actual weight(kg))) / (72 x serum creatinine(mg/dl))

You may not qualify if:

• Collecting duct, papillary, or chromophobe type renal cell carcinoma without a clear cell component are excluded. Transitional cell carcinoma of the renal pelvis is excluded
• No more than two prior systemic regimens for renal cell carcinoma
• Phase I: No prior treatment with sorafenib. Phase II: No prior treatment with prior anti-VEGF therapies, including sorafenib, sunitinib, thalidomide, or bevacizumab
• No prior treatment with RAD001, CCI-779, or similar agents
• Prior surgery, radiation therapy, or systemic therapy for renal cell carcinoma within 4 weeks of starting study treatment
• History of or known brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan
• Any of the following within 12 months prior to study drug administration: myocardial infarction, unstable or severe angina, coronary or peripheral artery bypass graft, NYHA functional Class II, III, IV congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
• Hypertension that is unable to be controlled with medications
• Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness
• "Currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered to have a less than 30% risk of relapse
• Current treatment on another clinical trial
• Pregnant or breastfeeding
• Chronic treatment with systemic steroids or other immunosuppressive agent
• Patients with an active bleeding diathesis or on oral vitamin K antagonist medication (except low dose warfarin)
• History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of stomach or small bowel that could interfere with absorption, distribution, metabolism, or excretion of study drugs

Sponsors & Collaborators

• University of California, San Francisco: lead
• Novartis: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Everolimus; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney 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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Charles Ryan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine and Urology

Study Record Dates

• First Submitted: October 3, 2006
• First Posted: October 6, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

US (1)