Study of Muscle Energy Metabolism in RCC Patients Treated With Sunitinib

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02428335
• Date of registration: 21/04/2015
• Prospective Registration: Yes
• Primary sponsor: AHS Cancer Control Alberta
• Public title: Study of Muscle Energy Metabolism in RCC Patients Treated With Sunitinib
• Scientific title: Evaluation of Technetium-99m Sestamibi to Determine Muscle Energy Metabolism in RCC (Renal Cell Cancer) Patients Treated With Sunitinib
• Date of first enrolment: June 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02428335
• Study type: Observational

Countries of recruitment

Canada

Contacts

• Name: Michael Sawyer, MD
• Affiliation: Alberta Health Services

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed informed consent before any study procedures completed

2. Patients must have histologically or cytologically confirmed RCC.

3. Four weeks must have elapsed since prior chemotherapy, hormonal therapy, targeted
therapy or radiation therapy. There is no restriction on the amount of bone marrow
previously radiated.

4. Recovery to baseline or, at most, grade 1 of all drug-related toxicities due to prior
chemotherapy, radiation, hormonal therapy, or molecular targeted therapy, expect for
alopecia.

5. Male / female subject = 18 years of age

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of <2 (Karnofsky >70%)

7. Life expectancy of at least 12 weeks

8. Normal organ and marrow function as defined by :

- absolute neutrophil count (ANC) > 1500/mcL

- hemoglobin (Hb) > 90 g/L

- platelet count = 1000.000/mcL,

- total bilirubin = 1.5 x the upper limit of normal range (ULN)

- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN
(<5 x ULN presence of liver metastases)

- creatinine < 1.5 x institutional ULN

9. Cardiac ejection fraction by MUGA scan or echocardiogram must be >50% for patients at
baseline.

10. Ability to understand the purpose of the study and the willingness to sign a written
informed consent document

11. Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment. Standard Nuclear Medicine department
pregnancy screening will be conducted prior to each 99mTc-sestamibi scan. Women of
childbearing potential and men must agree to use adequate contraception prior to study
entry and for the duration of study participation. The investigator is requested to
advise the patient how to achieve an adequate contraception.

12. Patients must give written informed consent prior to any study-specific screening
procedures with the understanding that the patient may withdraw consent at any time
without prejudice.

Exclusion Criteria:

1. Patients who have had chemotherapy, hormonal therapy, molecular targeted therapy, or
radiotherapy within 4 weeks prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier.

2. Patients may not be receiving any other investigational agents, chemotherapy,
immunotherapy, radiotherapy, or molecular targeted agents.

3. Prior treatment with a drug with known anti-angiogenic properties, including other
tyrosine kinase inhibitors to VEGFR

4. Any psychological, familial, sociological, or geographical conditions that do not
permit medical follow-up and compliance with the study protocol.

5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, HIV, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements.

6. Patients that are on therapeutic dose of coumadin or an INR of 1.5 c ULN. Patients
that are on low dose coumadin (2mg or less for patency of the central venous catheter)
or therapeutic dose of low molecular weight heparin will be allowed.

7. Patients who cannot swallow

8. Patients who are breast-feeding.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Fatigue

Renal Cell Cancer

Primary Outcome(s)

99mTc-sestamibi uptake in muscle cells [Time Frame: 12 weeks from start of treatment]

99mTc-sestamibi uptake in muscle cells [Time Frame: 24 weeks from start of treatment]

99mTc-sestamibi uptake in muscle cells [Time Frame: 36 weeks from start of treatment]

Secondary Outcome(s)

Incidence of sunitinib related fatigue [Time Frame: 36 weeks after the start of sunitinib treatment]

Secondary ID(s)

Sestamibi 1.0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors