Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or … (NCT02495103) | Clinical Trial Compass
TerminatedPhase 1/2
Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
Stopped: Vandetanib is no longer available as Sanofi has decided not to provide additional drug. All subjects are off-study.
United States7 participantsStarted 2015-08-26
Plain-language summary
Background:
\- There are no established treatments for people with certain advanced kidney cancers. These tumors often don't respond well to currently available treatments. Researchers believe that two drugs that treat other diseases metformin and vandetanib could help people with advanced kidney cancer.
Objective:
\- To test the combination of metformin and vandetanib in people with advanced kidney cancer. Phase I of the study will determine a safe dose for the drugs. Phase II will test this dose in people with certain kidney cancers.
Eligibility:
* For Phase I, people 18 and over with advanced kidney cancer
* For Phase II, people 18 and over with advanced hereditary leiomyomatosis and renal cell cancer (HLRCC), succinate dehydrogenase renal cell carcinoma (SDH-RCC), or advanced papillary renal cell carcinoma not related to a hereditary syndrome
Design:
* The study will last many months.
* Participants will be screened with medical history and physical exam.
* Participants will take the study drugs by mouth every day.
* Participants will measure and record their blood pressure every day.
* Participants will have many tests:
* Blood and urine tests
* Magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET) scan, and other imaging tests: they will lie in machines that take pictures of their body.
* Electrocardiogram (ECG): soft electrodes will be stuck to the skin. A machine will record the hearts signals.
* Bone scan
* Some participants may have a gynecology evaluation or photos of skin tumors taken.
* Participants will have an optional tumor biopsy.
* After they stop taking the drugs, participants may have medical history, physical exam, and blood tests. They will be contacted once a year by phone to find out how they are doing.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis/Histology
✓. Phase I Component - Histologically confirmed advanced Renal Cell Carcinoma (RCC) of any subtype.
✓. Phase II Component - Advanced RCC associated with 1) Hereditary leiomyomatosis and renal cell carcinoma (HLRCC) or Succinate dehydrogenase (SDH) (Cohort 1); OR 2) advanced non HLRCC-related papillary RCC (Cohort 2).
✓. Phase 1: Patients must have evaluable disease
✓. Phase 1- Patients with clear cell RCC must have either declined, be ineligible to receive, have progressed on, or be intolerant to high dose Interleukin 2 (IL-2), or standard first and second line Vascular endothelial growth factor (VEGF), or mammalian target of rapamycin (mTOR) targeted agents. As there is no standard therapy for metastatic non-clear cell RCC, no prior therapy is required.
✓. Phase 2- No more than two prior VEGF-pathway targeted agents
✓. No previous treatment with vandetanib. Previous or ongoing treatment with metformin is allowed.
Exclusion criteria
✕
What they're measuring
1
Phase 1 Component - Maximum Tolerated Dose (MTD) of Vandetanib and Metformin When Used in Combination in Patients With Metastatic Renal Cell Carcinoma (RCC)
Timeframe: 42 days after the last patient starts therapy.
2
Phase 2 Component - Percentage of Participants With an Overall Response Rate Following Treatment With the Combination of Vandetanib and Metformin
Timeframe: Approximately 8 weeks after initiation of therapy, every 8 weeks thereafter for the first 32 weeks, and then every 12 weeks while on treatment
. Known serious allergic reaction to vandetanib or metformin.
✕. Brain metastases or spinal cord compression that requires treatment, unless the treatment ended at least 4 weeks before starting protocol therapy and the condition has been stable without steroid treatment for at least 10 days.
✕. Major surgery (includes any surgery that carries significant risk of blood loss, extended periods of general anesthesia, or requires at least an overnight hospital admission) within 28 days before starting treatment or inadequately healed incision/scar from prior surgery.
✕. Any unresolved chronic toxicity greater than Common Terminology Criteria for Adverse Event (CTCAE) Grade 2 or greater from previous anti-cancer therapy (this criterion does not apply to alopecia).
✕. Unacceptable electrolyte values, including:
✕. Significant cardiac event (eg, myocardial infarction), New York Heart Association (NYHA) classification of heart disease greater than or equal to 2 within 12 weeks before starting treatment, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
✕. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled by medication are permitted.
✕. Hypertension not controlled by medical therapy (systolic blood pressure greater than 140 millimeter of mercury \[mmHg\] or diastolic blood pressure greater than 90 mmHg).