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Carcinoma, Renal CellPhase 1/2NCT00448149

Phase I/II Trial of RAD001 Plus Nexavar in Patients With Kidney Cancer

A Phase 1/2 study testing RAD001 and Sorafenib in people with Carcinoma, Renal Cell, run by The Methodist Hospital Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to see whether the combination for RAD001 and Nexavar® works better when given together than they do alone. The purpose of the first phase of this study is to determine the best dose of RAD001 given with Nexavar®, and to see what effects, good and/or bad, the study drug has on the subject… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
RAD001 and Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
Dec 2006to Jun 2009
Phase
Phase 1/2
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

  • Histologic confirmed predominant clear cell renal cell carcinoma.
  • Patients must have progressive metastatic disease.
  • Paraffin RCC tissue blocks or unstained slides must be available.
  • Karnofsky performance status > 70% .
  • Not pregnant
  • Age > 18
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  • Initial laboratory values must meet requirements
  • Phase I: No more than three prior systemic and/or investigative therapy for MRCC. Previous therapy may include prior single agent exposure to RAD001 or Nexavar®. Four weeks must have elapsed from previous therapy.
  • Phase II: No more than one prior systemic and/or investigative therapy of any kind for MRCC. Four weeks must have elapsed from previous therapy.
  • Phase II: Previous therapy may not include RAD001 or Nexavar®.
  • Phase II: Patients with primary tumor in place are strongly encouraged to undergo nephrectomy prior to initiation of study agent.
  • Phase II: Prior palliative radiotherapy to metastatic lesion(s) is permitted. Patient must have adequately recovered from the acute toxicities of this treatment.
  • Phase II: All major surgery of any type and/or radiotherapy must be completed at least 4 weeks prior to registration.

Who cannot join

  • No ongoing hemoptysis or cerebrovascular accident within 12 months, or peripheral vascular disease with claudication on less than 1 block, or history of clinically significant bleeding.
  • No deep venous thrombosis or pulmonary embolus within one year and no ongoing need for full-dose oral or parenteral anticoagulation.
  • No evidence of current central nervous system (CNS) metastases.
  • No significant cardiovascular disease
  • No patients with uncontrolled hypertension
  • Any ongoing requirement for systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency) or other immunosuppressants are not permitted.
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  • Patients with a pre-existing thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication are ineligible.
  • No uncontrolled psychiatric disorder.
  • Patients with delayed healing of wounds, ulcers, and/or bone fractures are not eligible.
  • Patients with a 'currently active' second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a 'currently active' malignancy if they have completed anti-cancer therapy and are considered by their physician to be a less than 30% risk of relapse.
  • Pregnant women are excluded
  • All fertile patients must use adequate contraception (barrier method) while on study and for three months thereafter. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
  • Prior treatment with any investigational drug within the preceding 4 weeks.
  • Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, severe infection, severe malnutrition, ventricular arrhythmias, chronic liver or renal disease, active upper GI tract ulceration).
  • A known history of HIV seropositivity.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I/II Trial of RAD001 Plus Nexavar® For Patients With Metastatic Renal Cell Carcinoma

The purpose of this study is to see whether the combination for RAD001 and Nexavar® works better when given together than they do alone. The purpose of the first phase of this study is to determine the best dose of RAD001 given with Nexavar®, and to see what effects, good and/or bad, the study drug has on the subject and the subject's tumor. This study will also observe side effects experienced by the subject.

Read the detailed description

Despite significant progress in understanding the biology of renal cell carcinoma (RCC), it is estimated that over 35, 000 people in the United States will be diagnosed and approximately 12, 000 have died from this disease in 2005. Renal cell carcinoma presently ranks tenth as the leading cause of cancer death and constitutes 3% of all solid neoplasms.

In contrast to many other malignancies, treatment for RCC is limited. Treatment remains a highly difficult and perplexing challenge due to its resistance to both chemotherapy and hormone therapy and limited response to cytokines. Despite recent advances in our fundamental knowledge of RCC biology and development of molecular therapeutics, more clinical research will be required to best guide our use of these exciting new agents in combination regimens.

The combination of RAD001 and Nexavar®, in current clinical trials with minimal toxicity, represents a treatment regimen which should be investigated for tolerance and toxicity as well as initial phase II efficacy. The study is designed to evaluate the MTD. Following the completion of the phase I, utilizing the MTD, Phase II study is designed to evaluate the anti-tumor activity.

Being tested
RAD001, Sorafenib
Keywords
Kidney cancer, Renal cell carcinoma, Metastatic RCC
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RAD001Drug

    Also called Everolimus

    RAD001 will be administered orally once a day, daily, without interruption per 4 wk cycle for 2 cycles. MTD is established in Phase I portion of trial (2.5, 5 or 10mg). If responding, additional therapy will be given.

  • SorafenibDrug

    Also called Nexavar®, BAY-4900

    A dose of 400mg of Nexavar® will be administered orally twice a day, daily, without an interruption per 4 week cycle for 2 cycles. If responding, additional therapy will be given.

Study groups in NCT00448149
Study groupRoleWhat they receive
1ExperimentalTo establish the maximally tolerated dose (MTD) of RAD001 in combination with Nexavar®
Receives: Drug: RAD001; Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: To establish the maximally tolerated dose (MTD) and safety profile of RAD001 in combination with Nexavar® in patients with metastatic renal cell carcinoma (MRCC).

    Measured: 1 year

  2. Phase II: Study the anti-tumor effects of RAD001 plus Nexavar®

    Measured: 2 years

Secondary outcomes (5)

  1. Phase II: Response rate

    Measured: restaging every 8 weeks

  2. Duration of tumor response

    Measured: restaging every 8 weeks

  3. Progression free survival

    Measured: restaging every 8 weeks

  4. Overall survival

    Measured: restaging every 8 weeks

  5. Study the safety of RAD001 plus Nexavar® given at MTD.

    Measured: AEs as occur

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00448149
Sponsor's protocol ID
PAC IRB#1006-0152
Other IDs
RCC-06-102
Status last verified
Mar 2016
First submitted
15 Mar 2007
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RAD001 and Sorafenib in people with Carcinoma, Renal Cell, run by The Methodist Hospital Research Institute 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 13 inclusion and 16 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 17 Mar 2016. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Phase I: To establish the maximally tolerated dose (MTD) and safety profile of RAD001 in combination with Nexavar® in patients with metastatic renal cell carcinoma (MRCC). (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00448149.

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 17 Mar 2016.

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