Optimizing Pazopanib Exposure in RCC Patients

NCT02089802 | Terminated Phase 2

• 1 other identifier: IQUO/01 OPERA
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Locally Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma

Keywords

RCC

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days after each dose optimization.

Secondary Outcomes (9)

• Comparison of tumor response of patients with normal and low Pazopanib plasma trough levels.

  Up to 28 days after last dose.

• Objective remission rate.

  Up to 28 days after last dose.

• Progression free survival.

  Up to 28 days after last dose.

• Overall survival.

  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.

  Up to 28 days after last dose.

Study Arms (1)

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).

Drug: Pazopanib

Interventions

Pazopanib DRUG

Normal plasma level patients and low plasma level patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Interessenverband zur Qualitätssicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland e.: lead
• OnkoDataMed GmbH: collaborator

Study Sites (3)

Gesundheitszentrum Holzminden

Holzminden, Lower Saxony, 37603, Germany

Location

Private Practice Kamann

Leipzig, Saxony, 04357, Germany

Location

Private Practice Geiges

Berlin, 10719, Germany

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Goetz Geiges, MD

  IQUO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 18, 2014
• Study Start: February 25, 2014
• Primary Completion: March 22, 2016
• Study Completion: March 22, 2016
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

DE (3)