Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006412

Trial Description

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Title

Optimizing Pazopanib Exposure in RCC Patients Through Therapeutic Drug Monitoring Followed by Intrapatient Dose Escalation

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Trial Acronym

OPERA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Optimization of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic
Drug Monitoring followed by Individual Dose Escalation.

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Brief Summary in Scientific Language

This is an open, multi-center, intraindividual dose-optimization study. Patients with
locally advanced or metastatic renal cell carcinoma receive 800 mg Pazopanib daily. After 14
days the Pazopanib plasma concentration is determined. In patients who show good
tolerability and plasma trough levels of ≤ 20 µg/mLthe daily dose is increased in 200 mg
steps until plasma trough levels of > 20 µg/mL are achieved or dose-limiting toxicities
occur, a daily dose of 1600 mg is reached, or there is disease progression.

After each dose optimization the plasma concentration is determined after 14 days (day
11-15). If indicated, dose optimization is performed 21 days after the previous dose
optimization (on day 18-24).

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Organizational Data

  •   DRKS00006412
  •   2014/10/30
  •   2014/03/03
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02089802  (ClinicalTrials.gov)
  •   IQUO/01 OPERA  (Interessenverband zur Qualitätssicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland e.)
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Health Condition or Problem studied

  •   Locally Advanced Renal Cell Carcinoma
  •   Metastatic Renal Cell Carcinoma
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
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Interventions/Observational Groups

  •   Drug: Pazopanib
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

- Determine if in patients with a Pazopanib plasma trough level of ≤ 20 μg/mL a plasma trough level of > 20 ≤g/mL can be achieved by dose escalation.; time frame: 14 days after each dose optimization.

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Secondary Outcome

- Comparison of tumor response of patients with normal and low Pazopanib plasma trough levels.; time frame: Up to 28 days after last dose.; Comparison of patients with normal Pazopanib plasma trough levels ("normal plasma level patients; NPLP) with patients with low Pazopanib plasma trough levels ("Low plasma level patients"; LPLP) with regard to the therapeutic result.
- Objective remission rate.; time frame: Up to 28 days after last dose.
- Progression free survival.; time frame: Up to 28 days after last dose.
- Overall survival.; time frame: Up to 28 days after last dose.
- Comparison of LPLP in whom the plasma trough level could be optimized successfully and LPLP in whom the plasma trough level could not be optimized with regard to above parameters.; time frame: Up to 28 days after last dose.
- Correlation of plasma trough levels and side effects, especially high blood pressure.; time frame: Up to 28 days after last dose.
- Correlation of the occurrence of high blood pressure with oncological result (response rate).; time frame: Up to 28 days after last dose.
- Recording of demographic data, compliance, concomitant medication, and correlation with plasma trough levels (LPLP / NPLP).; time frame: Up to 28 days after last dose.
- Examination of life quality.; time frame: Up to 28 days after last dose.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
  •  
  •  
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Recruitment

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  •   2014/02/27
  •   100
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- signature of informed consent

- age ≥ 18 years

- histologically confirmed renal cell carcinoma with clear cell component and either
locally progressed or metastasized

- ECOG ≤ 2

- No previous systemic therapy for locally progressed or metastasized renal cell
carcinoma (previous adjuvant or neo-adjuvant therapy is permitted)

- Adequate organ function

- Female patients with child-bearing potential with negative serum pregnancy test
within 2 weeks prior to first dose of study medication and adequate contraception

- Lactating females

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Exclusion Criteria

- Clinically suspected and known metastases of the central nervous system or
carcinomatous meningitis except in asymptomatic patients with previously treated
CNS-metastases and no necessity of steroids or anti-epileptic medication ≥ 6 months
prior to start of the study medication

- Clinically significant gastrointestinal conditions with risk of increase of
gastrointestinal bleeding due to (but not limited to)

- active peptic ulceration

- known intraluminal metastases with risk of bleeding

- chronic-inflammatory intestinal disease (like Morbus Crohn, ulcerative colitis) or
another gastrointestinal disease with increased risk of perforation

- abdominal fistulas in anamnesis

- Clinically significant gastrointestinal conditions which can influence absorption of
the IMP, among others (but not limited to)

- malabsorption syndrome

- resection of stomach or small bowel

- Current uncontrolled infection

- QTc corrected for heart frequency according to the Bazett formula

- One or more of the following cardiovascular diseases within the last 6 months in the
anamnesis:

- cardiac angioplasty or coronary stent implantation

- myocardial infarction

- instable angina pectoris

- coronary-arterial bypass surgery

- symptomatic peripheral arterial occlusive disease

- Heart failure NYHA III or IV

- Poorly controlled high blood pressure

- Cerebrovascular disease, including transitory ischemic attacks, pulmonary artery
embolism or untreated deep vein thrombosis within 6 months of study inclusion

- Previous major surgery or traumas within 28 days prior to start if study treatment or
non-healing wound, fracture or ulcer

- Clinical signs of active bleeding or bleeding diathesis

- Known endobronchial lesions or lesions infiltrating the large lung arteries

- Haemoptyses of > 2.5 mL within 8 weeks prior to first intake of study medication

- Any other severe and/or instable medical or psychiatric pre-existing or other
condition influencing patient safety, consent capacity or compliance within the study

- Incapacity or rejection to stop not allowed medication prior to first intake of study
drug and pause for the duration of the trial

- Treatment with one of the following anti-tumour therapies:

- Radiation or tumour embolism within 14 days before first intake of study drug

- Chemotherapy, Immunotherapy, biological therapy, study medication or hormonal therapy
within 14 days or 5 half-lives of the respective substance (whichever is longer)
before first intake of the study drug. Neo-adjuvant or adjuvant therapy must have
been completed for at least 6 months.

- Any present toxicity > CTC 1° from prior anti-tumour therapy and/or toxicities
worsening in severity except alopecia

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Addresses

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    • Interessenverband zur Qualitätssicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland e.
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    •   [---]*
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    • OnkoDataMed GmbH
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    •   [---]*
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    • IQUO
    • Goetz Geiges, MD 
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    •   [---]*
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    • Andrea Lockner 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.