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Phase I Study of Vorinostat and Sorafenib in Advanced Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase I Study of Vorinostat and Sorafenib in Advanced Cancer

A Phase I Safety and Tolerability Study of Vorinostat in Combination With Sorafenib in Patients With Advanced Solid Tumors, With Exploration of Two Tumor-type Specific Expanded Cohorts at the Recommended Phase 2 Dose

NCT00635791•University of Colorado, Denver

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of giving vorinostat and sorafenib tosylate together in treating patients with kidney or non-small cell lung cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may stop the growth of solid tumors by blocking blood flow to the tumor. Giving vorinostat together with sorafenib tosylate may kill more tumor cells.

Detailed Description

The main purpose of this study is to: * Evaluate the safety of vorinostat in combination with sorafenib. * Determine the largest dose of vorinostat + sorafenib that can be given safely to humans. * Determine if vorinostat + sorafenib are effective in stopping tumors from growing or in decreasing their size. * Study the side effects of vorinostat + sorafenib.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Parts A: Histologically or cytologically documented solid tumor malignancy or non-Hodgkin's lymphoma (Part B: renal cell carcinoma, Part C: non-small cell lung carcinoma) with clinical evidence of advanced and/or metastatic disease, which is refractory to established forms of therapy or for which no effective therapy exists, or for which sorafenib alone would be considered by the investigator as an appropriate therapy; patients who have refused available standard therapies would also be deemed eligible
•In Part A, evaluable disease by radiology and/or a recognized serum tumor marker is required; in Parts B and C, measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) is required
•Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
•Predicted life expectancy ≥ 12 weeks
•Patients may have had prior therapy, providing the following conditions are met:
•* Patients must have recovered from any treatment related toxicities (with the exception of alopecia) to ≤ CTC grade 1 (fatigue, and neurotoxicity at grade 2 are permissible if stable for \> 3 months) prior to registration
•* Chemotherapy: A minimum of 5 predicted half-lives of the agent must have elapsed between the end of treatment and registration on to the study; when half-lives are not available the principle of 2 weeks for once daily medications and 3 weeks for agents given less frequently will be adopted, but discussion with the principal investigator is recommended
•* Hormonal therapy: Patients may have had prior anticancer hormonal therapy provided it is discontinued \> 4 weeks prior to registration into the study; however, patients with prostate cancer with evidence of progressive disease may continue on therapy which produces medical castration (eg, goserelin or leuprorelin) provided this was commenced at least three months earlier
•* Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of bone marrow reserve provided that they have recovered from the acute, toxic effects of radiotherapy prior to registration; a minimum of 7 days must have elapsed between the end of radiotherapy to non-target lesions and registration into the study (minimum of 28 days for target lesions)
•* Surgery: Previous surgery is permitted provided that wound healing has occurred prior to registration
+10 more criteria

Exclusion Criteria

•Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation in the study
•History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
•Concurrent anticancer therapy (with the exception of hormonal therapies as discussed above)
•Pregnant or breast-feeding females (documented methods of birth control are required in those with reproductive potential)
•Symptomatic brain metastases which are not stable, require steroids, or anti-epileptic medication
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs
•History of grade 3 or greater toxicities with vorinostat or sorafenib previously at equivalent daily doses or lower than those planned on being administered within this study
•Exposure to other histone deacetylase (HDAC) inhibitors (e.g. sodium valproate) within 30 days of planned commencement of study drugs, other exposures to HDAC inhibitor and sorafenib in combination
•Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
•Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
+11 more criteria

Locations (1)

University of Colorado Cancer Center

Aurora, Colorado, United States

Key Dates

Start Date

March 1, 2008

Primary Completion Date

October 1, 2011

Completion Date

March 1, 2012

Last Updated

June 20, 2013

Enrollment

ACTUAL participants

Conditions

Malignant Solid TumourRenal Cell CarcinomaNon Small Cell Lung Carcinoma

Interventions

Sorafenib

DRUG

Vorinostat

DRUG

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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: June 20, 2013Data 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.

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Phase I Study of Vorinostat and Sorafenib in Advanced Cancer

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma