Malignant Solid TumourPhase 1NCT00635791
Phase I Study of Vorinostat and Sorafenib in Advanced Cancer
A Phase 1 study testing Sorafenib and Vorinostat in people with Malignant Solid Tumour and Renal Cell Carcinoma, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumour, Renal Cell Carcinoma, Non Small Cell Lung Carcinoma
- What is being tested?
- Sorafenib and Vorinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Supportive therapy including bisphosphonates is permissible; previous use of myeloid and erythroid growth factor support is permissible, but not within 2 weeks of commencement of study; primary prophylactic use of myeloid and erythroid growth factors is not permitted within the study, but intervention or secondary prophylaxis is permitted if instituted following the documentation of ≥ grade 3 neutropenia or ≥ grade 2 anemia (hemoglobin)
- International Normalized Ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anticoagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib/vorinostat and monitored at least weekly, or as defined by the local standard of care, until INR is stable; vorinostat and sorafenib have both been reported to elevate INR in those on coumadin derivatives
- Neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 75 x 10^9/L
- Bilirubin ≤ 1.5 x Upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and/or alanine transaminase (ALT) ≤ 2.5 x ULN (ie, ≤ CTC grade 1) or ≤ 5 x Upper limit of normal (UNL) if patient has documented liver metastases (ie, ≤ CTC grade 2)
- Serum creatinine ≤ 1.5 x ULN
- Patient must be accessible for repeat dosing and follow-up
- Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study; women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
- Patients must provide verbal and written informed consent to participate in the study, including pharmacokinetic sampling
Who cannot join
- 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
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- 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
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event >= Common Toxicity Criteria for Adverse EffectS (CTCAE) grade 2 within 4 weeks of first dose of study drug
- Any other hemorrhage/bleeding event >= CTCAE grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
- Use of St. John's Wort or rifampin (rifampicin)
- Known or suspected allergy to sorafenib, vorinostat or any planned agent given in the course of this trial
- Any condition that impairs patient's ability to swallow whole pills
- Any clinically significant malabsorption problem
- Clinically significant, in the investigator's opinion, pre-existing cardiac dysfunction or myocardial infarction within 6 months prior to planned commencement of study drugs
- Any other condition, which in the investigator's opinion, would compromise the safety of the patient or the feasibility of completing the study objectives through the use of this patient
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Sorafenib, Vorinostat
- Keywords
- Malignant Solid Tumour, Renal cell carcinoma, Non small cell lung carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called NexAVAR
Given by mouth
VorinostatDrug
Also called Zolinza
Given by mouth
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib tosylate and vorinostat | Experimental | Patients receive sorafenib tosylate by mouth twice a day on days 1-21 and vorinostat by mouth every day on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Sorafenib; Drug: Vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The primary objective of this study is to determine the MTD for vorinostat in combination with the recommended dose of sorafenib 400 mg when given daily in a 21-day cycle and thereby establish a recommended Phase 2 dose of the combinations when administered daily in patients with advanced solid tumors
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumourStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Bayer
- Responsible party
- Sponsor
- Investigators
- David R Camidge, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635791
- Sponsor's protocol ID
- 07-0537.cc
- Other IDs
- NCI-2013-00413
- Status last verified
- Jun 2013
- First submitted
- 7 Mar 2008
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00635791
- Acronym / sponsor ID
- 07-0537.cc
- Keywords
- Malignant Solid Tumour, Renal cell carcinoma, Non small cell lung carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Bayer
- Study start
- Mar 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib tosylate and vorinostat | Experimental | Drug: Sorafenib, Drug: VorinostatPatients receive sorafenib tosylate by mouth twice a day on days 1-21 and vorinostat by mouth every day on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibAlso: NexAVARGiven by mouth | Drug | Sorafenib tosylate and vorinostat |
| VorinostatAlso: ZolinzaGiven by mouth | Drug | Sorafenib tosylate and vorinostat |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Up to 21 days
The primary objective of this study is to determine the MTD for vorinostat in combination with the recommended dose of sorafenib 400 mg when given daily in a 21-day cycle and thereby establish a recommended Phase 2 dose of the combinations when administered daily in patients with advanced solid tumors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Camidge, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sorafenib and Vorinostat in people with Malignant Solid Tumour and Renal Cell Carcinoma, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.