PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02383251: Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer
Official title: A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance
Conditions: Ovarian Cancer
Summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.
Interventions:
description: Pazopanib 600mg during the fist cycle. Then, if there is not heptic triuyble, the dose could be increased to 800mg
name: Pazopanib
other_name: Votrient
type: Drug
description: Arm 1 : Paclitaxel 65mg/m² Arm 2: Paclitaxel 80mg/m²
name: Paclitaxel
other_name: Taxol
type: Drug
Study arms:
design_group_description: Arm 1 :<br/>Pazopanib alone during 1 week at 600 mg (1x400mg and 1x200mg), per day, taken orally without food at least one hour before or two hours after a meal.<br/>Then:<br/>* Pazopanib 600 mg (1x400mg and 1x200mg), per day, taken orally without food at least one hour before or two hours after a meal.<br/>* Paclitaxel 65 mg/m2 i.v. on days 1, 8, 15 every 28 days until progression of disease or toxicity
design_group_title: Pazopanib/Paclitaxel association
design_group_type: Experimental
design_group_description: Arm 2 :<br/>* Paclitaxel 80mg/m2 i.v. on days 1, 8, 15<br/>* every 28 days until progression of disease or toxicity
design_group_title: Paclitaxel alone
design_group_type: Active Comparator
Sponsor: Arcagy-Gineco
Collaborators: Novartis AG
Drug name mappings:
name: 白蛋白结合型紫杉醇
lang: CN
name: Albumin-Bound Paclitaxel
lang: EN
name: パクリタキセル(JAN)
lang: JP
name: 培唑帕尼
lang: CN
name: Pazopanib Hydrochloride
lang: EN
name: パゾパニブ塩酸塩
lang: JP
Clinical trial NCT01137916: Study to Evaluate Imatinib in Desmoid Tumors
Official title: Phase II Study to Evaluate Glivec (Imatinib Mesylate) to Induce Progression Arrest in Aggressive Fibromatosis / Desmoid Tumors Not Amenable to Surgical Resection With R0 Intent or Accompanied by Unacceptable Function Loss
Conditions: Aggressive Fibromatosis
Desmoid Tumor
Summary: The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.
Interventions:
description: 800 mg
name: Imatinib
other_name: Glivec
type: Drug
Study arms:
design_group_description: Imatinib 800 mg
design_group_title: drug
design_group_type: Experimental
Sponsor: Heidelberg University (EMCL)
Collaborators: Novartis AG
Drug name mappings:
name: 甲磺酸伊马替尼
lang: CN
name: Imatinib mesylate
lang: EN
name: イマチニブメシル酸塩
lang: JP
Clinical trial NCT00729222: Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With Heart Failure
Conditions: Heart Failure
Summary: The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.
Interventions:
description: rolofylline placebo IV infusion over 4 hours.
name: Comparator: Placebo
type: Drug
description: rolofylline 30 mg IV infusion over 4 hours.
name: rolofylline
type: Drug
Study arms:
design_group_description: Placebo
design_group_title: 1
design_group_type: Placebo Comparator
design_group_description: rolofylline
design_group_title: 2
design_group_type: Experimental
Sponsor: Merck Sharp & Dohme Corp.
Collaborators: NovaCardia, Inc.
Drug name mappings:
name: 罗咯茶碱
lang: CN
name: Rolofylline
lang: EN
Clinical trial NCT06672978: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Official title: A Multi-Center, Open-Label, Single-Arm, Phase 2 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Vabomere (Meropenem-Vaborbactam) In The Treatment Of Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Conditions: Acute Pyelonephritis
Complicated Urinary Tract Infection
Summary: The primary objective of the study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
Interventions:
description: Administered as specified in the treatment arm
name: Meropenem-Vaborbactam
other_name: Vabomere
type: Drug
description: Administered as prescribed by the study physician in accordance with local guidelines and regulations.
name: Antibiotics
type: Drug
Study arms:
design_group_description: Participants will receive meropenem-vaborbactam via an IV infusion for a minimum of 3 days, for up to 14 days.<br/>Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3.
design_group_title: Cohort 1: Age 6 to < 12 years
design_group_type: Experimental
design_group_description: Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days.<br/>Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3.
design_group_title: Cohort 2: Age 2 to < 6 years
design_group_type: Experimental
design_group_description: Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days.<br/>Participants with clinical improvement have the option to switch to an oral antibiotic or home IV therapy after Day 3.
design_group_title: Cohort 3: Age 3 months to < 2 years
design_group_type: Experimental
Sponsor: Rempex Pharmaceuticals, Inc.
Collaborators: Biomedical Advanced Research & Development Authority (Barda)
Drug name mappings:
name: 美罗培南/韦博巴坦
lang: CN
name: Meropenem/Vaborbactam
lang: EN
Clinical trial NCT02051309: Guanfacine Clinical Trial for Smoking Cessation
Official title: Phase-II Clinical Trial Evaluating Guanfacine for Smoking Cessation
Conditions: Smoking Cessation
Summary: Adult daily smokers motivated to quit smoking will be randomized to extended-release guanfacine (6mg/day) or placebo and will enroll in an 8-week treatment period combining medication with brief behavioral support. The investigators hypothesize that the active dose of guanfacine compared to placebo will increase rates of prolonged smoking abstinence at the end of the 8-week treatment phase.
Interventions:
description: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication. Follow up at 1 month, 2 months and 6 months.
name: Guanfacine
other_name: Intuniv
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_description: Guanfacine 6mg/day extended release
design_group_title: Guanfacine 6mg/day ER
design_group_type: Experimental
design_group_description: Placebo matching capsule
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 盐酸胍法辛
lang: CN
name: Guanfacine hydrochloride
lang: EN
name: グアンファシン塩酸塩
lang: JP
Clinical trial NCT00006004: Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
Official title: A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
Conditions: Lung Cancer
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer.
Interventions:
name: carboplatin
type: Drug
name: cisplatin
type: Drug
name: gemcitabine hydrochloride
type: Drug
name: paclitaxel
type: Drug
Study arms:
Sponsor: Eastern Cooperative Oncology Group
Collaborators: National Cancer Institute
Drug name mappings:
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
Clinical trial NCT00539643: Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma
Official title: A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)
Conditions: Hepatocellular Carcinoma
Liver Cancer
Hepatoma
Summary: The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.
Interventions:
description: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
name: Bead Block microspheres
type: Device
description: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
name: Bead + Dox Arm
type: Other
Study arms:
design_group_description: Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
design_group_title: Bead Arm
design_group_type: Active Comparator
design_group_description: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
design_group_title: Bead + Dox Arm
design_group_type: Active Comparator
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Columbia University
Drug name mappings:
name: 盐酸多柔比星
lang: CN
name: Doxorubicin Hydrochloride
lang: EN
name: ドキソルビシン塩酸塩
lang: JP
Clinical trial NCT03171415: Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers
Official title: A Double Blind, Randomized, Placebo Controlled, Dose Escalation Phase 2a Clinical Trial for the Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers
Conditions: Obesity
Weight Loss
Overweight and Obesity
Summary: Obesity is a direct result of food-intake in excess of body energy expenditure. Thus, induction of increased energy expenditure via the activation of thermogenesis at targeted anatomical sites can counterbalance obesity. This trial aims to study RZL-012, a novel compound, in treating obesity by activating thermogenesis in subcutaneous fat.
Interventions:
description: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.
name: RZL-012
type: Drug
description: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.
name: Placebo
type: Drug
Study arms:
design_group_description: A single-time injection, multiple subcutaneous injections of RZL-012 administered into 8-36 sites (0.1mL per site):<br/>1. 40mg RZL-012 -administered at 8 sites<br/>2. 80mg RZL-012 - administered at 16 sites<br/>3. 120mg RZL-012 - administered at 24 sites<br/>4. 180mg RZL-012 - administered at 36 sited
design_group_title: RZL-012
design_group_type: Experimental
design_group_description: A single-time injection, multiple subcutaneous injections of Placebo administered into 8-36 sites (0.1mL per site)
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Raziel Therapeutics RT Ltd.
Collaborators: Spaulding Clinical Research LLC
Drug name mappings:
name: RZL-012
lang: EN
Clinical trial NCT01032850: Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
Official title: Sorafenib in Combination With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
Conditions: Hepatocellular Carcinoma
Summary: This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the following:
* how effective this combination of study drugs will be in treating HCC
* how long subjects respond to these study drugs
* what types of side effects can be expected, and
* how severe the side effects are
All subjects in this study will receive:
* Sorafenib twice a day by mouth
* Capecitabine twice a day by mouth
Treatment will be given in a 28-day treatment cycle.
Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days 1-7 and 15-21 of the cycle
Interventions:
description: Intervention: Sorafenib twice a day by mouth (400mg), Capecitabine twice a day by mouth (850mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
name: Sorafenib & Capecitabine
other_name: Capecitabine
Nexavar
Sorafenib
Xeloda
type: Drug
Study arms:
design_group_description: Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400mg) Capecitabine twice a day by mouth (850mg)
design_group_title: Arm 1: Sorafenib & Capecitabine
design_group_type: Experimental
Sponsor: New Mexico Cancer Care Alliance
Collaborators: Bayer AG
Drug name mappings:
name: 甲苯磺酸索拉非尼
lang: CN
name: Sorafenib Tosylate
lang: EN
name: ソラフェニブトシル酸塩
lang: JP
name: 卡培他滨
lang: CN
name: Capecitabine
lang: EN
name: カペシタビン
lang: JP
Clinical trial NCT03817411: Telatinib in Combination With Capecitabine/ Oxaliplatin in 1st Line Gastric or GEJ Cancer
Official title: A Phase II Randomized Trial of Telatinib in Combination With Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin as First-Line Therapy in Patients With HER2-negative Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
Conditions: Gastric Cancer
Summary: The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib combination in terms of progression-free survival (PFS) in patients previously untreated for advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.
Interventions:
description: 300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
name: Telatinib
other_name: EOC315
type: Drug
description: 1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).
name: Capecitabine
type: Drug
description: 130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles.
name: Oxaliplatin
type: Drug
description: 300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
name: Placebos
type: Drug
Study arms:
design_group_description: Patients receive Telatinib orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.
design_group_title: Telatinib+Capecitabine+Oxaliplatin
design_group_type: Active Comparator
design_group_description: Patients receive placebo orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days.
design_group_title: Placebos+Capecitabine+Oxaliplatin
design_group_type: Placebo Comparator
Sponsor: EOC Pharma (Thaizhou) Co., Ltd.
Collaborators: Zhongshan Hospital Fudan University
Shanghai East Hospital
Drug name mappings:
name: 特拉替尼
lang: CN
name: Telatinib
lang: EN
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
name: 卡培他滨
lang: CN
name: Capecitabine
lang: EN
name: カペシタビン
lang: JP
Clinical trial NCT03271047: Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
Official title: An Open-label Phase 1b/2 Study of Binimetinib Administered in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
Conditions: MSS
RAS-mutant Colorectal Cancer
Summary: This is a multicenter, open-label, Phase 1B/2 study to evaluate the safety and assess the preliminary anti-tumor activity of binimetinib administered in combination with nivolumab or nivolumab + ipilimumab in adult patients with advanced metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) disease and presence of a RAS mutation that have received at least one prior line of therapy and no more than 2 prior lines of therapy. The study contains a Phase 1b period to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) and schedule of binimetinib followed by a randomized Phase 2 period to assess the efficacy of the combinations.
Interventions:
description: Orally, twice daily.
name: binimetinib
type: Drug
description: Intravenously (IV) every 4 weeks (Q4W)
name: nivolumab
type: Drug
description: intravenously (IV) every 8 weeks (Q8W)
name: ipilimumab
type: Drug
Study arms:
design_group_description: binimetinib + nivolumab
design_group_title: Phase 1b / Arm 1A
design_group_type: Experimental
design_group_description: binimetinib + nivolumab + ipilimumab
design_group_title: Phase 1b / Arm 1B
design_group_type: Experimental
design_group_description: binimetinib + nivolumab
design_group_title: Phase 2 / Arm 2A
design_group_type: Experimental
design_group_description: binimetinib + nivolumab + ipilimumab
design_group_title: Phase 2 / Arm 2B
design_group_type: Experimental
Sponsor: Pfizer Inc.
Collaborators: Bristol Myers Squibb Co.
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
name: 贝美替尼
lang: CN
name: Binimetinib
lang: EN
name: ビニメチニブ
lang: JP
Clinical trial NCT01323400: Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST)
Official title: A Phase II Randomized Multicentre Study Evaluating the Efficacy of Pazopanib+Best Supportive Care (BSC) Versus BSC Alone in Metastatic and/or Locally Advanced Unresectable GIST, Resistant to Imatinib and Sunitinib
Conditions: GIST
Summary: The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.
Interventions:
description: Pazopanib is administered orally at 800 mg/day (one dose every morning). A dose modification is possible in case of documented toxicity, according to specific algorithms.
name: Pazopanib
type: Drug
description: Best supportive care according to the investigator's judgment (chemotherapy, immunotherapy, hormone therapy are not allowed).<br/>Non-targeted radiation therapy is tolerated, as antalgic strategy. Surgery is tolerated in case of emergency.
name: Best supportive care
type: Other
Study arms:
design_group_description: Pazopanib (800 mg/day) + Best supportive care according to the investigator's judgement.<br/>Pazopanib treatment is started on the day after randomization until radiological progression according to RECIST or until documented toxicity. In case of radiological progression, pazopanib may be continued (if the investigator wishes so) if a clinical benefit (pain reduction, 1 point increase in performance status) is observed.
design_group_title: Pazopanib
design_group_type: Experimental
design_group_description: Best supportive care according to the investigator's judgment. Upon progression, compassionate treatment by pazopanib is possible according to eligibility criteria.
design_group_title: Best supportive care
design_group_type: Other
Sponsor: Centre Léon Bérard Lyon et Rhône-Alpes
Collaborators: GSK Plc
Drug name mappings:
name: 培唑帕尼
lang: CN
name: Pazopanib Hydrochloride
lang: EN
name: パゾパニブ塩酸塩
lang: JP