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Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer

Phase I Study of Tipifarnib (R115777) and Sorafenib (BAY 43-9006) in Patients With Biopsiable Advanced Cancers

NCT00244972•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of tipifarnib when given together with sorafenib tosylate in treating patients with biopsiable cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Tipifarnib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity and to determine maximum tolerated dose (MTD) of tipifarnib in combination with sorafenib (sorafenib tosylate). SECONDARY OBJECTIVES: I. Preliminary assessment of tipifarnib and sorafenib efficacy (objective response). II. To determine signaling pathway profiles of patients treated with tipifarnib and sorafenib who are amenable to biopsy by reverse phase protein microarray (RPPA) analysis. OUTLINE: This is a dose-escalation study of tipifarnib. Patients receive sorafenib tosylate orally (PO) once daily (QD) or twice daily (BID) on days 1-28 and tipifarnib PO QD or BID on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients may be allowed to continue the treatment after the 12 courses if there is continued clinical response or disease stabilization, and patients do not have significant toxicities. After completion of study treatment, patients are followed up for 4 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have had =\< 4 prior chemotherapy regimens; patients must have advanced cancer that is refractory to standard therapy or for whom there is no standard therapy that increases survival by three months
•Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
•Life expectancy of greater than 12 weeks
•Leukocytes \>= 3,000/mcL
•Absolute neutrophil count \>= 1,500/mcL
•Platelets \>= 100,000/mcL
•Total bilirubin =\< 1.5
•Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
•Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (a calculated creatinine clearance \[CrCL\] is acceptable)
•International normalized ratio (INR)/prothrombin time (PT) =\< within institutional guidelines for biopsy procedures (=\< 16 seconds)
+4 more criteria

Exclusion Criteria

•Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
•Patients may not be receiving any investigational agents other than BAY 43-9006 and R115777
•Patients with known brain metastases are excluded except for patients who have had treated brain metastases and are currently not taking anti-seizure medications or steroids
•Patients may not have allergies to imidazoles (e.g., clotrimazole, ketoconazole, miconazole, econazole) or a history of allergic reactions attributed to any other compound of similar chemical or biologic composition to either BAY 43-9006 or R115777
•Uncontrolled hypertension with systolic blood pressure of \> 140 mmHg or diastolic pressure \> 90 mmHg; however, patients with well-controlled hypertension are eligible
•Patients must not have any evidence of current history of bleeding diathesis
•Patients cannot be on therapeutic anticoagulation; prophylactic anticoagulation therapy (e.g., low-dose warfarin) of venous or arterial access devices is allowed provided that the requirements for prothrombin time (INR; international normalized ratio of prothrombin time) and partial thromboplastin time (PTT) are maintained; patients will be monitored on a weekly basis for the first (1st) cycle of treatment until the INR/PT has stabilized for 2 weeks consecutively; if patients discontinue the R115777 patients will be monitored weekly until INR/PT is stabilized for 2 weeks consecutively
•Patients may not have grade 2 or greater peripheral neuropathy
•Patients with any condition that impairs their ability to swallow pills are excluded
•Patients cannot be receiving enzyme-inducing antiepileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, phenobarbital) nor any other cytochrome P450 family 3, subfamily A, polypeptide (CYP3A4) inducer such as rifampin or St. John's wort
+4 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

October 1, 2005

Primary Completion Date

March 1, 2017

Completion Date

March 1, 2017

Last Updated

April 27, 2017

Enrollment

ACTUAL participants

Conditions

Advanced Malignant Neoplasm

Interventions

Laboratory Biomarker Analysis

OTHER

Sorafenib Tosylate

DRUG

Tipifarnib

DRUG

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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RECRUITINGPHASE1/PHASE2

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

NCT06581419

Advanced Malignant NeoplasmAdvanced or Metastatic Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer

Inclusion Criteria

Exclusion Criteria

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

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