Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.

GW786034

Placebo

GSK Clinical Trials

Phase II, multi-center, two-stage study utilising a randomised discontinuation design to evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.

GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma

A Phase II Study of GW786034 Using a Randomised Discontinuation Design in Subjects With Locally Recurrent or Metastatic Clear-Cell Renal Cell Carcinoma

The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a \>=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.

The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.

Using RECIST criteria: date of first confirmed tumor response (CR or PR) to date of tumor progression or to death. Participants who did not progress or die were censored at their last radiologic assessment. Only participants who had a response were analyzed.

Progression-free Survival is defined as the interval between the first day of treatment and the earliest date of disease progression or death due to any cause, whichever occurred first. Progressive disease is defined as a \>=20% increase in target lesions.

GlaxoSmithKline

Pazopanib 800 milligrams (mg) (tablets) administered orally once a day

Pazopanib 800 mg

Age, Continuous

Sex: Female, Male

White

Asian-Japanese/East Asian/South East Asian HER

African American/African Heritage (HER)

Asian-Central/South Asian Heritage

American Indian or Alaska Native and White

Asian-Mixed Asian Heritage

Native Hawaiian or other Pacific Islander

Race/Ethnicity, Customized

GSK Response Center

Complete Response

Partial Response

Stable Disease

Progressive Disease

Not evaluable

Complete Response + Partial Response

All Enrolled: all participants who received at least one dose of pazopanib

Overall Response by RECIST Criteria

Unknown

Subset of the All Enrolled Population including only the first 60 participants

Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants

All participants in the Enrolled Population who had a CR or PR

Duration of Response

Pazopanib 800 mg (tablets) administered orally once a day

All Enrolled Population. Participants who did not progress or die were censored at their last radiologic assessment.

Progression-free Survival

Overall Study

Sarcoma

Leiomyosarcoma

Sarcoma, Synovial

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Synovial Sarcoma

pazopanib

The purpose of this study is to evaluate the activity and tolerability of pazopanib in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of pazopanib in this subject population.

Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma

Phase II Study of GW786034 in Patients With Relapsed or Refractory Soft Tissue Sarcoma

Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a \>=20% increase in target lesions.

Overall survival is defined as the time from start of therapy until death. Participants who were still alive at the time of analysis were censored.

Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause. Assessments of progression were made by the investigator.

Overall response is the number of participants who had a best outcome of a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study. Progressive disease (PD), a \>=20% increase in target lesions. Clinical progression is progression of disease without documented radiological evidence.

Pazopanib 800 milligram (mg) (tablets) administered orally once a day

Includes all participants enrolled in the study

Missing

CR+PR+SD

Pazopanib 800 mg - Adipocytic Tumors

Pazopanib 800 mg - Leiomyosarcoma

Pazopanib 800 mg - Synovial Sarcoma

Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)

Intent-to-Treat (ITT) Population: All eligible participants entered into the study and who had taken \>=1 dose of investigational product. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.

Progression Free Survival at Week 12

ITT Population. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.

Overall Survival

Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.

Progression Free Survival

Overall Response

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

The purpose of this study is to determine how effective and safe a new investigational drug is in treating patients with relapsed or refractory multiple myeloma. The treatment involves daily dosing. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma	NCT00244764	Carcinoma, Rena...	GW786034 Placebo	21 Years -	GlaxoSmithKline
Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma	NCT00297258	Sarcoma, Soft T...	pazopanib	21 Years -	GlaxoSmithKline
Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma	NCT00256880	Carcinoma, Rena...	GW786034	21 Years -	GlaxoSmithKline
Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma	NCT00256880	Carcinoma, Rena...	GW786034	21 Years -	GlaxoSmithKline
Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma	NCT00297258	Sarcoma, Soft T...	pazopanib	21 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for pazopanib(gw786034)