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Locally Advanced or Metastatic Non-clear Cell Type Renal Cell CarcinomaPhase 2NCT01538238

pazopanib_NCRCC,Ph2 STUDY

A Phase 2 study testing pazopanib in people with Locally Advanced or Metastatic Non-clear Cell Type Renal Cell Carcinoma, run by Samsung Medical Center at 1 site in South Korea.

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

Recent advances in understanding the biology and genetics of renal cell carcinoma (RCC) have led to major therapeutic implications. Von Hippel-Lindau (VHL) gene inactivation, present in the majority of sporadic forms of RCC, leads to a defective VHL protein, followed by an active transcription of hypoxia-inducible… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
pazopanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSouth Korea
Study dates
2 May 2012to 14 Nov 2015
Phase
Phase 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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 19 years
  • Subject must provide written informed consent
  • Histologically confirmed confirmation of renal cell carcinoma with more than 50% of a non clear cell histologic component:
  • Include papillary type, chromophobe type, unclassified cell types; Exclude collecting duct and sarcomatoid type. (including sarcomatoid type or collecting duct type should be less than 5% in total cancer tumor)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1
  • At least one measurable lesion by RECIST 1.1, which has not been affected previously with radiotherapy
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  • Locally advanced or metastatic (stage IV) disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
  • Subject who received immune therapy (interleukin-2, interferon) at least 6weeks time prior to the enrollment and at least 3 weeks time requires who received mTOR inhibitor (everolimus, temsirolimus) therapy prior to the enrollment.
  • Adequate organ system function as defined in the Table Definitions
  • Absolute neutrophil count (ANC):1.5 X 10^9/L
  • Hemoglobin: 9 g/dL (5.6 mmol/L)
  • Platelets: 100 X 10^9/L
  • Prothrombin time (PT) or international normalized ratio (INR):1.2 X ULN
  • Activated partial thromboplastin time (aPTT):1.2 X ULN
  • Total bilirubin:1.5 X ULN
  • Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) should be in normal range in accordance with the site reference lab normal range
  • Serum creatinine: if >1.5 mg/dL: Calculated creatinine clearance (CIcr)≥30 mL/min
  • Urine Protein to Creatinine Ratio(UPC) <1 a. Blood transfusion is not allowed within 7days. b. Subject who takes anticoagulator therapy is eligible c. If urine protein to creatinine ratio is (UPC)≥1, must confirm the 24 hours urine and the protein should be <1g
  • A female is eligible to enter and participate in this study if she is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
  • A hysterectomy
  • A bilateral oophorectomy (ovariectomy)
  • A bilateral tubal ligation
  • Is post-menopausal Subjects
  • not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).
  • Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
  • Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product
  • Oral contraceptive
  • Injectable progestogen
  • Implants of levonorgestrel
  • Estrogenic vaginal ring
  • Percutaneous contraceptive patches
  • Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
  • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
  • Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) # Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.

Who cannot join

  • Patients who have 50% or more for component of clear cell type renal cell carcinoma
  • Prior malignancy cannot be included excepting for these cases: Subjects who have had another malignancy and have been disease-free for 2 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma and follicular or papillary thyroid cancer are eligible.
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic for 4 weeks, and have had no requirement for steroids or anti-seizure medication for 2 weeks prior to first dose of study drug. Screening with CNS imaging studies (magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
  • Treatment with any of the following anti-cancer therapies:
  • ① radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib / RFA or cryoablation within 14 days prior to the first dose of pazopanib OR
  • ② Prior treatment history with angiogenesis inhibitors such as sunitinib, sorafenib, bevacizumab is not permitted (prior MET inhibitor or c-kit inhibitor are also not permitted)
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  • ③ Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
  • Clinically significant gastrointestinal damage or disease that may affect absorption of pazopanib:
  • (Active peptic ulcer disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or resection of the small bowel, history of stomy, abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28days prior to enrollment.)
  • Patients(male/female) of reproductive potential who are not use an effective contraceptive method
  • Pregnant, lactating women
  • Corrected QT interval (QTc) > 480 msecs
  • History of any severe disease or medical condition, significant heat failure(Class II, III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)) or pulmonary dysfunction, presence of uncontrolled active infection(requiring antibiotics)
  • History of clinically significant cardiac disease, arrhythmia and myocardial infarction
  • Symptomatic peripheral vascular disease
  • Poorly controlled hypertension [the patients who have systolic blood pressure (SBP) of <140 mmHg or diastolic blood pressure (DBP) of <90mmHg regardless antihypertensive treatment are eligible. If systolic blood pressure is 140-150mmHg, blood pressure (BP) must be re-assessed in a week and SBP <150mmHg is eligible.]
  • History of cerebrovascular accident including transient ischemic attack (TIA), untreated pulmonary embolism or deep venous thrombosis (DVT) within the past 2 months.
  • Prior major operation within 28 days prior to the first dose of study drug.
  • Evidence of active bleeding or bleeding diathesis.
  • Known lesions infiltrating major pulmonary vessels(simple abut lesion is eligible)
  • Hemoptysis in excess of 2.5 mL per cough (or one half teaspoon) due to cancer within 8 weeks of the first dose of study drug.
  • Unable or unwilling to discontinue use of prohibited medications listed in protocol for at least 14 days(whichever is longer) prior to the first dose of study drug and for the duration of the study.
  • Patients who are not capable of planned F/U visits due to pre-existing psychiatric, social and family condition or geographical reason.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung medical Center

    Seoul

Other trials in South Korea

About this study

Recent advances in understanding the biology and genetics of renal cell carcinoma (RCC) have led to major therapeutic implications. Von Hippel-Lindau (VHL) gene inactivation, present in the majority of sporadic forms of RCC, leads to a defective VHL protein, followed by an active transcription of hypoxia-inducible genes, including vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), c-kit, and others. However, the concept of VHL inactivation in RCC and the subsequent malignant phenotype is almost exclusively seen in patients with clear cell histology.

The data about efficacy of VEGF receptor inhibitors for non-clear cell RCC (NCRCC) is rare until now. Recently, however, sunitinib and sorafenib showed its worth for NCRCC in extended access programs.1-3 Although it is not certain, the underlying mechanism of their action might lie in that papillary, chromophobe, and sarcomatoid type overexpress c-kit, which is also a target of both drugs and could therefore provide a therapeutic target for non-clear cell subtypes.4-7 Pazopanib is also a potent and selective, orally available, small molecule inhibitor of VEGFR-1,-2, and -3, PDGF-α, PDGF-β, and c-kit tyrosine kinases. It has been validated and licensed for advanced clear cell RCC (CCRCC).8 However, there is very few data about its efficacy for NCRCC.

In this study, we try to evaluate the efficacy of pazopanib in metastatic NCRCC.

Being tested
pazopanib

What participants receive

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

  • pazopanibDrug

    pazopanib 800mg qd until progression or unacceptable toxicity

Study groups in NCT01538238
Study groupRoleWhat they receive
pazopanibExperimentalpazopanib 800mg qd
Receives: Drug: pazopanib

What is being measured

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

  1. Overall response rates

    Measured: 2years

Secondary outcomes (4)

  1. Progression-free survival

    Measured: 2years

  2. Overall survival

    Measured: 2years

  3. Number of Adverse Events

    Measured: 2years

  4. Exploratory analysis

    c-kit protein expression,the relationship between efficacy and tumoral fibroblast growth factor receptor 1 gene amplification (FISH), the relationship between efficacy and MET mutation in papillary carcinoma, the relationship between efficacy and microvessel density and/or VEGF-R2 expression in tumor by immunohistochemistry

    Measured: 2years

Timeline

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

  1. First posted24 Feb 2012 (estimated)
  2. Study start2 May 2012
  3. Primary completion28 Feb 2015
  4. Study completion14 Nov 2015

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01538238
Sponsor's protocol ID
2012-01-056
Status last verified
Apr 2017
First submitted
20 Feb 2012
Last updated
26 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib in people with Locally Advanced or Metastatic Non-clear Cell Type Renal Cell Carcinoma, run by Samsung Medical Center at 1 site in South Korea.

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 36 inclusion and 23 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 26 Apr 2017. 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 South Korea. 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 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?

Overall response rates (time frame: 2years). 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 NCT01538238.

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 26 Apr 2017.

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