Second-line Pazopanib Renal Cell Carcinoma (RCC) Study. CTRIAL-IE (ICORG) 10-01, V5

NCT01566747 | Completed Phase 2

• 1 other identifier: CTRIAL-IE (ICORG) 10-01
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 9

Brief Summary

This is a phase II open label, single arm study evaluating treatment with pazopanib post sunitinib treatment in 43 patients with metastatic renal cell carcinoma. Patients will receive 800mg pazopanib per day given continuously until disease progression. Patients must have received treatment with sunitinib and relapsed. Patient must have received prior treatment with sunitinib for at least 12 weeks. Prior treatment with either temsirolimus or everolimus in addition to sunitinib is allowed. The trial design uses a Simons two stage design with an interim analysis planned after the first 15 evaluable patients. If 8 or more of the first 15 evaluable patients remains disease free at 4 months, then a further 28 patients will be enrolled for a total of 43 metastatic renal cell cancer patients. It is estimated that there could be up to 10% of patients dropping out and so to achieve the required number of 43 evaluable patients the study will recruit up to 48 patients to ensure that 43 complete if stage 2 is required. Patients will receive treatment until disease progression, unacceptable toxicity or withdrawal of patient consent. Response assessments will be carried out every 8 weeks until disease progression. Safety assessments will be carried out every 4 weeks (plus a visit for liver function tests after 2 weeks) for the first six months and then every eight weeks until disease progression. A further safety assessment will be carried out 4 weeks after treatment discontinuation.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Up to 4 years

Study Arms (1)

Pazopanib

EXPERIMENTAL

Pazopanib 800mg day to be given continuously until disease progression.

Drug: Pazopanib

Interventions

Pazopanib DRUG

Pazopanib 800mg day to be given continuously until disease progression.

Pazopanib

Eligibility Criteria

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

You may qualify if:

• Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.
• Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
• Note: It is not necessary that informed consent be obtained within the protocol-specified screening window.
• Age ≥ 18 years
• Diagnosis of metastatic/unresectable renal cell carcinoma of the clear cell type or with a component of clear cell histology
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Measurable disease by RECIST criteria (Version 1.1)
• Eligible patients must have been treated with sunitinib for a minimum of 12 weeks (2 cycles). Patients must have evidence of progressive disease following treatment with sunitinib as assessed by the site investigator on the basis of CT scans and other appropriate clinical documentation. Patients who received sunitinib for 12 weeks (2cycles) but stopped the drug due to toxicity rather than disease progression are also eligible for this study.
• The Investigator should be aware of the patient's intolerance/toxicity with prior sunitinib treatment and take this in to account when assessing eligibility for the pazopanib study.
• Patients who have had prior treatment with either temsirolimus or everolimus are also eligible for the trial.
• No other prior treatment with bevacizumab, sorafenib, immunotherapies, chemotherapy, biologic therapy or investigational therapy is allowed.
• Previous radiotherapy (RT) is permissible provided the measurable disease is outside the RT port. RT must be completed \> 2 weeks prior to registration.
• Adequate organ system function as defined below
• Definitions for Adequate Organ Function System Laboratory Values
• Hematologic Absolute neutrophil count (ANC) ≥ 1.5 X 109/L Hemoglobina ≥ 9 g/dL (5.6 mmol/L)

You may not qualify if:

• Prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases (surgery plus or minus radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible: a) are asymptomatic, b) have had no evidence of active CNS metastases for \> or = 6 months prior to enrolment, and c) have no requirement for steroids or Enzyme -inducing anticonvulsants EIACs.
• Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases.
• Clinically significant gastrointestinal abnormalities that may increase the risk for Gastrointestinal (GI) bleeding including, but not limited to:
• Active peptic ulcer disease
• Known intraluminal metastatic lesion/s with suspected bleeding
• Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
• History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel.
• Presence of uncontrolled infection.
• Prolongation of corrected QT interval (QTc) \> 480 msecs using Bazett's formula
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting

Sponsors & Collaborators

• Cancer Trials Ireland: lead
• Novartis: collaborator

Study Sites (9)

Beaumont Hospital

Dublin, Leinster, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Leinster, Ireland

Location

Mater Private Hospital

Dublin, Leinster, Ireland

Location

Cork University Hospital

Cork, Ireland

Location

The Adelaide & Meath Hospital Dublin incorporating the National Children's Hospital

Dublin, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Mid-Western Regional Hospital

Limerick, Ireland

Location

Waterford Regional Hospital

Waterford, Ireland

Location

Karolinska University Hospital

Stockholm, Sweden

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 Design

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

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 29, 2012
• Study Start: March 1, 2011
• Primary Completion: April 7, 2020
• Study Completion: July 15, 2020
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

SE (1); IE (8)