Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

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

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Sutent capsule, once daily administered per the locally approved product information.

Non Interventional

Pfizer CT.gov Call Center

The Sutent® Observational Study is being proposed to assess the real-world usage patterns and effectiveness and tolerability of treatment of Indian patients with advanced renal cell cancer with Sutent®. Generation of such information is expected to aid everyday clinical decision-making by Indian doctors and will add to the body of generalizable evidence.

The assignment of the patient to Sutent® treatment is not decided in advance by this noninterventional study protocol, but falls within current practice. The decision to prescribe Sutent® is clearly not driven by the decision to include the patient in this study.The sample size for this study is not based on statistical considerations. It is expected that a minimum of 100 patients will be enrolled in the study by the end of the first year and the data collected would be adequate to fulfill the observational objectives of the study.The study will be initiated at 10 sites across India during the 1st year. The study may be expanded with the addition of new sites during the 2nd year.

Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent

PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented.

An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.

Age, Continuous

Sex: Female, Male

Relatively small sample size might limit any useful interpretation and applicability of data for larger populations.

Pfizer ClinicalTrials.gov Call Center

Data was not analyzed since PFS for all participants was censored either due to inadequate baseline assessments, absence of on-study disease assessment, or being on follow-up for progression.

Progression Free Survival (PFS)

Per protocol (PP) analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started sunitinib treatment.

Percentage of Participants With Objective Response (OR)

Dose Reduction

Dose Interruption

Avoidance of Hot water for Cleaning Hands and Feet

Safety analysis set included all enrolled participants who started treatment with sunitinib.

Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events

Number of Participants Who Required Management of Other Adverse Events

Overall Study

Molgramostim

Sargramostim

Vaccines

Immunomodulating Agents

Monatide (IMS 3015)

Adjuvants, Immunologic

Immunologic Factors

Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)

Intradermal application of peptide vaccine with Montanide ISA-51

peptide vaccine

Granulocyte Macrophage Colony Stimulating Factor

Montanide ISA-51

Arnulf Stenzl, Prof.

Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).

Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides

Tolerability, as measured by number of Participants with Adverse Events

All cause Mortality, as measured as length of Overall Survival

Progression-free Survival, as measured as time to radiographic progression

Immune Response, as as measured by in vitro and in vivo T cell response on day 0 and day 70. In selected cases additional immune response evaluation might be applicable.

University Hospital Tuebingen

Symptoms and General Pathology

Recurrence

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Epithelial-myoepithelial Carcinoma

Angiogenesis Inhibitors

ATN-161

The purpose of this study is to determine an active dose of ATN-161 for future studies while establishing preliminary evidence of effectiveness in patients with renal cell cancer.

Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a requirement for the growth of nearly all tumors. Clear cell renal cell carcinoma (CCRCC) is a malignancy characterized by abundant vascularization and a high degree of resistance to chemotherapy which makes antiangiogenic therapy an intriguing concept for treatment. This concept has been established by the initial successes observed in recent studies of antiangiogenic therapies for CCRCC. ATN-161 is an attractive candidate for investigation as a therapeutic agent in CCRCC because it binds to several fully activated integrins, which are essential downstream components in the angiogenic signaling cascade.

Functional imaging using dceMRI has been demonstrated as an effective way to show effects on the vasculature across different tumors, including CCRCC. Preclinical experiments have shown that ATN-161 affects tumor perfusion in tumor bearing mice. Therefore, use of imaging in this study is expected to be an effective method for evaluating the antiangiogenic response to ATN-161.

Patients will be administered ATN-161 three times weekly by short (10 minute) IV infusion at 1 of 3 dose levels (20, 100, and 600 mg). Patients will be treated until progression of disease, unacceptable drug toxicity, or withdrawal of consent occurs.

Functional imaging (dceMRI) will be performed within 1 week prior to first treatment, again during the second week of treatment, and finally during the fourth week of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent	NCT00836745	Renal Cell Carc...	Non Interventio...	18 Years - 75 Years	Pfizer
Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides	NCT02429440	Renal Cell Canc... Advanced Renal ...	peptide vaccine Granulocyte Mac... Montanide ISA-5...	18 Years -	University Hospital Tuebingen
Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides	NCT02429440	Renal Cell Canc... Advanced Renal ...	peptide vaccine Granulocyte Mac... Montanide ISA-5...	18 Years -	University Hospital Tuebingen
ATN-161 in Advanced Renal Cell Cancer	NCT00131651	Carcinoma, Rena...	ATN-161	18 Years -	Attenuon

Spots Global Cancer Trial Database for advanced renal cell cancer