Patient preference between pazopanib (Paz) and sunitinib (Sun): Results of a randomized double-blind, placebo-controlled, cross-over study in patients with metastatic renal cell carcinoma (mRCC)—PISCES study, NCT 01064310.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. CRA4502-CRA4502 ◽  
Author(s):  
Bernard J. Escudier ◽  
Camillo Porta ◽  
Petri Bono ◽  
Ugo De Giorgi ◽  
Omi Parikh ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Annual Meeting ◽  
Patient Preference ◽  
Renal Cell ◽  
Double Blind ◽  
Daily News ◽  
Double Blind Placebo ◽  
Online Supplement ◽  
Final Text

CRA4502 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.

Axitinib versus sorafenib as second‑line therapy in Asian patients with metastatic renal cell carcinoma (mRCC): Results from a registrational study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. LBA4537-LBA4537
Author(s):  
Shukui Qin ◽  
Feng Bi ◽  
Ying Cheng ◽  
Jun Guo ◽  
Xiu Bao Ren ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Second Line ◽  
Second Line Therapy ◽  
Daily News ◽  
Online Supplement ◽  
Asian Patients ◽  
Line Therapy ◽  
Final Text

LBA4537 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.

RTOG 0825: Phase III double-blind placebo-controlled trial evaluating bevacizumab (Bev) in patients (Pts) with newly diagnosed glioblastoma (GBM).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
Mark R. Gilbert ◽  
James Dignam ◽  
Minhee Won ◽  
Deborah T. Blumenthal ◽  
Michael A. Vogelbaum ◽  
...  
Keyword(s):  
Annual Meeting ◽  
Controlled Trial ◽  
Phase Iii ◽  
Newly Diagnosed ◽  
Double Blind ◽  
Daily News ◽  
Double Blind Placebo ◽  
Online Supplement ◽  
Newly Diagnosed Glioblastoma ◽  
Final Text

1 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Sunday, June, 2, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.

Results of the X-PECT study: A phase III randomized double-blind placebo-controlled study of perifosine plus capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic colorectal cancer (mCRC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. LBA3501-LBA3501
Author(s):  
Johanna C. Bendell ◽  
Thomas J. Ervin ◽  
Neil N. Senzer ◽  
Donald A. Richards ◽  
Irfan Firdaus ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Annual Meeting ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Daily News ◽  
Double Blind Placebo ◽  
Online Supplement ◽  
Final Text

LBA3501 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Sunday, June 3, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.

Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: Results of overall survival for CALGB 90206

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. LBA5019-LBA5019 ◽  
Author(s):  
B. I. Rini ◽  
S. Halabi ◽  
J. Rosenberg ◽  
W. M. Stadler ◽  
D. A. Vaena ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Annual Meeting ◽  
Clinical Oncology ◽  
Interferon Alpha ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Final Text

LBA5019 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. [Table: see text]

Randomized, Controlled, Double-Blind, Cross-Over Trial Assessing Treatment Preference for Pazopanib Versus Sunitinib in Patients With Metastatic Renal Cell Carcinoma: PISCES Study

2014 ◽  
Vol 32 (14) ◽  
pp. 1412-1418 ◽  
Author(s):  
Bernard Escudier ◽  
Camillo Porta ◽  
Petri Bono ◽  
Thomas Powles ◽  
Tim Eisen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Patient Preference ◽  
Renal Cell ◽  
Double Blind ◽  
Patient Reported ◽  
Intent To Treat

Purpose Patient-reported outcomes may help inform treatment choice in advanced/metastatic renal cell carcinoma (RCC), particularly between approved targeted therapies with similar efficacy. This double-blind cross-over study evaluated patient preference for pazopanib or sunitinib and the influence of health-related quality of life (HRQoL) and safety factors on their stated preference. Patients and Methods Patients with metastatic RCC were randomly assigned to pazopanib 800 mg per day for 10 weeks, a 2-week washout, and then sunitinib 50 mg per day (4 weeks on, 2 weeks off, 4 weeks on) for 10 weeks, or the reverse sequence. The primary end point, patient preference for a specific treatment, was assessed by questionnaire at the end of the two treatment periods. Other end points and analyses included reasons for preference, physician preference, safety, and HRQoL. Results Of 169 randomly assigned patients, 114 met the following prespecified modified intent-to-treat criteria for the primary analysis: exposure to both treatments, no disease progression before cross over, and completion of the preference questionnaire. Significantly more patients preferred pazopanib (70%) over sunitinib (22%); 8% expressed no preference (P < .001). All preplanned sensitivity analyses, including the intent-to-treat population, statistically favored pazopanib. Less fatigue and better overall quality of life were the main reasons for preferring pazopanib, with less diarrhea being the most cited reason for preferring sunitinib. Physicians also preferred pazopanib (61%) over sunitinib (22%); 17% expressed no preference. Adverse events were consistent with each drug's known profile. Pazopanib was superior to sunitinib in HRQoL measures evaluating fatigue, hand/foot soreness, and mouth/throat soreness. Conclusion This innovative cross-over trial demonstrated a significant patient preference for pazopanib over sunitinib, with HRQoL and safety as key influencing factors.

scholarly journals Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial

The Lancet ◽  
2016 ◽  
Vol 387 (10032) ◽  
pp. 2008-2016 ◽  
Author(s):  
Naomi B Haas ◽  
Judith Manola ◽  
Robert G Uzzo ◽  
Keith T Flaherty ◽  
Christopher G Wood ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
High Risk ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. CRA9013-CRA9013
Author(s):  
Ellen M. Lavoie Smith ◽  
Herbert Pang ◽  
Constance Cirrincione ◽  
Stewart Barry Fleishman ◽  
Electra D. Paskett ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Annual Meeting ◽  
Clinical Oncology ◽  
Phase Iii ◽  
Double Blind Trial ◽  
Double Blind ◽  
Daily News ◽  
Online Supplement ◽  
Blind Trial ◽  
Final Text

CRA9013 The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Monday, June 4, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News.

RENAVIV: A randomized phase III, double-blind, placebo-controlled study of pazopanib with or without abexinostat in patients with locally advanced or metastatic renal cell carcinoma.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. TPS681-TPS681 ◽  
Author(s):  
Rahul Raj Aggarwal ◽  
Scott Thomas ◽  
Ralph J. Hauke ◽  
Luke T. Nordquist ◽  
Pamela N. Munster
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Histone Acetylation ◽  
Renal Cell ◽  
Clear Cell ◽  
Locally Advanced ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

TPS681 Background: Abexinostat is a pan-histone deacetylase (HDAC) inhibitor that has shown promising activity in prior pre-clinical studies and early phase clinical trials. A phase 1b study of pazopanib plus abexinostat (Aggarwal et al. J Clin Oncol 2017) demonstrated strikingly durable responses in patients (pts) with clear cell renal cell carcinoma (RCC), including one patient with previously refractory disease with ongoing response for > 5 years’ duration. Induction of histone acetylation in peripheral blood mononuclear cells (PBMCs) was associated with durable treatment response. We hypothesize that the addition of abexinostat to pazopanib will significantly improve outcomes in patients with clear cell RCC. Methods: RENAVIV is a global, randomized, double-blind, placebo-controlled, two arm phase 3 study of pazopanib plus abexinostat versus pazopanib plus placebo, in pts with locally advanced or metastatic RCC with clear cell component. Up to one prior line of immunotherapy is allowed. Prior VEGF-targeting tyrosine kinase inhibitor treatment is prohibited. Stratification factors include: 1) Prior immunotherapy (yes/no) and 2) prognostic group (good, intermediate, poor). Pts randomized to pazopanib + placebo have the option of crossing over to receive pazopanib plus abexinostat at the time of disease progression. The primary endpoint is PFS by independent review committee. Secondary endpoints include PFS by investigator assessment, overall survival, safety, objective response rate (ORR), duration of response, patient-reported quality of life, and outcomes in cross-over population. Planned correlative studies include association between histone acetylation and HDAC expression in PBMCs with clinical outcomes. The total planned accrual is 413 pts, estimated to provide 90% power to detect a hazard ratio of 0.67 in the comparison of PFS between experimental versus control arms, with an overall two-sided type I error rate of 0.025. A pre-specified minimum of 50% of patients are required to have received prior immunotherapy. The first patient was enrolled in October 2018. Clinical trial information: NCT03592472.

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