Locally Advanced Renal Cell CarcinomaPhase 2OPERANCT02089802
Optimizing Pazopanib Exposure in RCC Patients
A Phase 2 study testing Pazopanib in people with Locally Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Interessenverband zur Qualitätssicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland e. at 3 sites in Germany.
Trial summary
Optimization of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic Drug Monitoring followed by Individual Dose Escalation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- What is being tested?
- Pazopanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesGermany
- Study dates
- 25 Feb 2014to 22 Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Private Practice Geiges
Berlin, 10719
Gesundheitszentrum Holzminden
Holzminden, Lower Saxony, 37603
Private Practice Kamann
Leipzig, Saxony, 04357
About this study
Official title: Optimizing Pazopanib Exposure in RCC Patients Through Therapeutic Drug Monitoring Followed by Intrapatient Dose Escalation
Optimization of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic Drug Monitoring followed by Individual Dose Escalation.
Read the detailed description
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).
- Being tested
- Pazopanib
- Keywords
- RCC
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
| Study group | Role | What they receive |
|---|---|---|
| Normal plasma level patients and low plasma level patients. | Experimental | 1. Patients with normal Pazopanib plasma trough levels; "normal plasma level patients" (NPLP).
2. Patients with low Pazopanib plasma trough levels, "low plasma level patients" (LPLP). Receives: Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days after each dose optimization.
Secondary outcomes (9)
Comparison of tumor response of patients with normal and low Pazopanib plasma trough levels.
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.
Measured: Up to 28 days after last dose.
Objective remission rate.
Measured: Up to 28 days after last dose.
Progression free survival.
Measured: Up to 28 days after last dose.
Overall survival.
Measured: 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.
Measured: Up to 28 days after last dose.
Correlation of plasma trough levels and side effects, especially high blood pressure.
Measured: Up to 28 days after last dose.
Correlation of the occurrence of high blood pressure with oncological result (response rate).
Measured: Up to 28 days after last dose.
Recording of demographic data, compliance, concomitant medication, and correlation with plasma trough levels (LPLP / NPLP).
Measured: Up to 28 days after last dose.
Examination of life quality.
Measured: Up to 28 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study start25 Feb 2014
- Primary completion22 Mar 2016
- Study completion22 Mar 2016
Why it stopped: Early termination due to lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interessenverband zur Qualitätssicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland e.
- Sponsor type
- University, hospital or other
- Collaborators
- OnkoDataMed GmbH
- Responsible party
- Sponsor
- Investigators
- Goetz Geiges, MD, Principal investigator, IQUO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089802
- Sponsor's protocol ID
- IQUO/01 OPERA
- Acronym
- OPERA
- Status last verified
- Aug 2017
- First submitted
- 3 Mar 2014
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pazopanib Exposure in RCC Patients Through Therapeutic Drug Monitoring Followed by Intrapatient Dose Escalation
- ClinicalTrials.gov ID
- NCT02089802
- Acronym / sponsor ID
- OPERA / IQUO/01 OPERA
- Keywords
- RCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to lack of recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Interessenverband zur Qualitätssicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland e.University, hospital or other
- Collaborators
- OnkoDataMed GmbH
- Study start
- 25 Feb 2014 (actual)
- Primary completion
- 22 Mar 2016 (actual)
- Study completion
- 22 Mar 2016 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optimization of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic Drug Monitoring followed by Individual Dose Escalation.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal plasma level patients and low plasma level patients. | Experimental | Drug: Pazopanib1. Patients with normal Pazopanib plasma trough levels; "normal plasma level patients" (NPLP). 2. Patients with low Pazopanib plasma trough levels, "low plasma level patients" (LPLP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pazopanib | Drug | Normal plasma level patients and low plasma level patients. |
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.
9 secondary outcomes
Comparison of tumor response of patients with normal and low Pazopanib plasma trough levels.
Time frame: Up to 28 days after last dose.
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.
Results and safety
The study was stopped early (reason given: Early termination due to lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goetz Geiges, MD principal investigator
IQUO
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib in people with Locally Advanced Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Interessenverband zur Qualitätssicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland e. at 3 sites in Germany.
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 8 inclusion and 30 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: stopped early, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 was stopped early (reason given: Early termination due to lack of recruitment). Results are not available in the source record.
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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2017.