ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01332266
Conditions: Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
Keywords: Cancer head and neck squamous cell carcinoma of the head and neck phase 1b phase 2
Sponsor: Eisai Inc.
Start date: 2011-09-19; Completion date: 2017-09-04
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) who receive either E7050 administered with cetuximab or cetuximab alone experience greater benefit.

Detailed description:
This open-label, multicenter, randomized study will consist of a Phase 1b: a safety run-in period with 3 ascending doses of E7050 in combination with cetuximab; and a Phase 2 portion: a randomized 2-arm period. Approximately 95 participants with platinum-resistant squamous cell carcinoma of the head and neck will be enrolled in the study (10-15 participants in the Phase 1b portion and 80 participants in the Phase 2 portion). Participants will only participate in either the Phase 1b or the Phase 2 portion of the study.

In the Phase 2 portion, participants will receive study treatment (E7050 plus cetuximab or cetuximab alone) for approximately six 28-day cycles (24 weeks). Beyond 24 weeks, participants who are experiencing clinical benefit may continue E7050 plus cetuximab, cetuximab alone or E7050 alone (Arm 1), or may continue cetuximab alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated.

Arms: arm 1: Phase 1b:

Cohort 1; 200 mg E7050 + 250 mg/m2 cetuximab Cohort 2; 300 mg E7050 + 250 mg/m2 cetuximab Cohort 3; 400mg E7050 + 250mg/m2 cetuximab

Phase 2: Arm 1; MTD E7050 + 250 mg cetuximab Arm 2; 250 mg cetuximab

Interventions: Drug cetuximab arm 2: Phase 2:

Arm 1; MTD E7050 + 250 mg/m2 cetuximab Arm 2; 250 mg/m2 cetuximab
Interventions: intervention 1: E7050 intervention 2: Cetuximab
Intervention descriptions: intervention 1: E7050 given orally at 200, 300, or 400 mg once daily. intervention 2: Cetuximab is given at an initial dose of 400 mg/m2 given as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a dose of 250 mg/m2 given as a 1-hour IV infusion on Day 8, Day 15, and Day 22 of Cycle 1, and Day 1, Day 8, Day 15, and Day 22 of each subsequent cycle.

Protocol documents:
Clinical trial NCT02337478
Conditions: Recurrent Adult Acute Myeloid Leukemia
Sponsor: Wake Forest University Health Sciences
Start date: 2015-06-05; Completion date: 2017-09-04
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot phase II trial studies how well vincristine sulfate liposome works in treating patients with acute myeloid leukemia that has returned after a period of improvement or has not responded to previous treatment. Drugs used in chemotherapy, such as vincristine sulfate liposome, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Liposomal encapsulation prolongs bioavailability (proportion of drug that enters the circulation when introduced into the body) of vincristine sulfate, and may increase its delivery to cancer cells with fewer side effects.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the feasibility of administering vincristine sulfate liposome injection (VSLI) to relapsed or refractory acute myeloid leukemia (AML) patients having failed, refused or not a candidate for at least one chemotherapy salvage regimen.

II. To observe the hematologic improvement-rate of VSLI in this patient population.

SECONDARY OBJECTIVES:

I. To observe the overall survival of patients treated with VSLI. II. To observe the response rate (complete remission \[CR\], complete remission with incomplete count recovery \[CRi\], partial response \[PR\], and morphologic leukemia free state \[MLFS\]) of VSLI in this patient population.

OUTLINE:

Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 6 months.

Arms: arm 1: Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Vincristine Sulfate Liposome intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given via injection intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01057225
Conditions: Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Sponsor: Mayo Clinic
Start date: 2010-03-01; Completion date: 2017-09-05
Enrollment: 64 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients with newly diagnosed active multiple myeloma.

Detailed description:
PRIMARY OBJECTIVES:

I. To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. (Phase I) II. In newly diagnosed myeloma to evaluate the response rate (CR, nCR, and VGPR) to carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone after four 28 day cycles. (Phase II)

SECONDARY OBJECTIVES:

I. Determine the overall response rate (CR, nCR, PR) after 4, 8, 12 cycles. II. Determine the duration of progression-free and overall survival for patients receiving this regimen.

III. To evaluate the incidence of toxicities for this regimen. IV. To evaluate the ability to successfully collect peripheral blood stem cells following four months of combination therapy.

OUTLINE: This is a phase I, dose escalation study of carfilzomib followed by a phase II study.

Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3 months, then every 3 months for 1 year, and then every 6 months for up to 3 years.

Arms: arm 1: Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
Interventions: intervention 1: carfilzomib intervention 2: cyclophosphamide intervention 3: thalidomide intervention 4: dexamethasone
Intervention descriptions: intervention 1: Given IV intervention 2: Given orally intervention 3: Given orally intervention 4: Given orally

Protocol documents:
Clinical trial NCT02148133
Conditions: Cytopaenia
Keywords: Eltrombopag Aplastic Anemia (AA) Thrombocytopenia Thrombopoietin Bone Marrow Bone Marrow Biopsy Hematopoietic Stem Cells Mature Blood Cells Pancytopenia Leukopenia Platelets
Sponsor: Novartis Pharmaceuticals
Start date: 2014-07-23; Completion date: 2017-09-05
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a non-randomized, open-label, phase II study to assess the efficacy and safety of eltrombopag in Japanese moderate or more severe aplastic anemia (AA) subjects with a platelet count \<30,000/microliter who were refractory to anti-thymocyte globulin (ATG)-based immunosuppressive therapy (IST), who have relapsed after ATG-based IST, or who are ineligible for ATG-based IST.

Eltrombopag was expected to improve trilineage blood cells and decrease transfusion frequency based on the result from the previous study in patients with severe AA. This study used the hematologic response rate, defined as the proportion of subjects showing improvement in at least one of the three blood cell lineages or a decrease in blood transfusion volume, as the primary endpoint.

A total of 36 subjects were screened and 21 were enrolled in the study. Treatment with eltrombopag started at 25 milligram (mg)/day and increased by 25 mg/day every 2 weeks according to the platelet count up to 100 mg/day. Response assessment was performed at 3 months after starting the study treatment (Week 13). Subjects in whom the treatment was assessed as effective continued with the study treatment. Subjects in whom the treatment was assessed as effective (when meeting any of the response criteria) at 6 months after starting the study treatment (Week 26) might enter the extension phase and continue the treatment with eltrombopag. The primary endpoint was the hematologic response rate at Week26.

Detailed description:

Arms: arm 1: Subjects were assigned the investigational product (eltrombopag 25 mg/day) orally once a day under fasting condition. The dose adjustment was done every 2 weeks according to the platelet count (increased by eltrombopag 25 mg/day every 2 weeks according to the platelet count up to 100 mg/day).
Interventions: intervention 1: Eltrombopag 12.5 mg intervention 2: Eltrombopag 25 mg
Intervention descriptions: intervention 1: White, round, film-coated tablets containing 12.5 mg of eltrombopag free acid (SB-497115-GR, eltrombopag) in each tablet intervention 2: White, round, film-coated tablets containing 25 mg of eltrombopag free acid (SB-497115-GR, eltrombopag) in each tablet

Protocol documents:
Clinical trial NCT02481050
Conditions: Breast Cancer
Keywords: Eribulin Mesylate Human Epidermal Growth Factor Receptor 2 Metastatic Breast Cancer HER2-Negative
Sponsor: Eisai Inc.
Start date: 2015-06-16; Completion date: 2017-09-05
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens.

Detailed description:
This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens. The study will be conducted in 3 Phases: a Pretreatment Phase (screening visit), a Treatment Phase (starting with Cycle 1 Day 1), and a Posttreatment Phase (End of treatment visit and survival follow up). Participants may remain on study drug as long as they demonstrate clinical benefit or until intercurrent illness, unacceptable toxicity, or disease progression occurs, until the participant withdraws consent, or death.

Arms: arm 1: Participants with metastatic HER2-negative breast cancer previously treated with 2 to 5 chemotherapy regimens.
Interventions: intervention 1: Eribulin Mesylate
Intervention descriptions: intervention 1: Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes biweekly on Day 1 and Day 15 of each 28-day cycle.

Protocol documents:
Clinical trial NCT02576860
Conditions: Rosacea
Sponsor: Maruho Co., Ltd.
Start date: 2015-10-01; Completion date: 2017-09-05
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

Detailed description:

Arms: arm 1: CLS001 (Omignan) gel applied once daily arm 2: Vehicle gel applied once daily
Interventions: intervention 1: CLS001 (Omiganan) intervention 2: Vehicle
Intervention descriptions: intervention 1: Topical gel intervention 2: Vehicle gel

Protocol documents:
Prot_000.pdf: 



































































































SAP_001.pdf:
Clinical trial NCT01780506
Conditions: HIV HIV Infections
Keywords: HIV Treatment Naive HIV 1 Infected Female Women
Sponsor: Gilead Sciences
Start date: 2012-12-26; Completion date: 2017-09-06
Enrollment: 872 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.

Detailed description:

Arms: arm 1: E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks arm 2: E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks arm 3: After study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated the study in that country.
Interventions: intervention 1: E/C/F/TAF intervention 2: E/C/F/TDF intervention 3: E/C/F/TDF Placebo intervention 4: E/C/F/TAF Placebo
Intervention descriptions: intervention 1: 150/150/200/10 mg FDC tablet administered orally once daily intervention 2: 150/150/200/300 mg FDC tablet administered orally once daily intervention 3: Tablet administered orally once daily intervention 4: Tablet administered orally once daily

Protocol documents:
Clinical trial NCT02404025
Conditions: Aplastic Anemia
Keywords: Eltrombopag rabbit anti-thymocyte globulin additive effect cyclosporine A bone marrow hematopoietic stem cells pancytopenia leukopenia platelets throbocytopenia mature blood cells bone marrow biopsy
Sponsor: Novartis Pharmaceuticals
Start date: 2015-05-12; Completion date: 2017-09-06
Enrollment: 10 participants; Allocation: ; Intervention model: 

Brief summary:
This was an open label, non-randomized, phase II study of eltrombopag in combination with rabbit ATG/CsA in subjects with moderate or more severe AA who did not received prior ATG/ALG-based immunosuppressive therapy. The objective was to assess additive effects of eltorombopag on overall response rate (ORR) at 6 months (Week 26) of treatment with ATG/CsA. Subjects were assessed at least weekly for safety during the period from the start of ATG/CsA to 4 weeks after the start of administration of eltrombopag. After that, subjects had visits every 2 weeks until Week 26. Subjects in whom the treatment was assessed as effective at Week 26 could continued treatment with eltrombopag after 6 months when clinically indicated at the discretion of the investigator. There were five follow-up visits: at discontinuation of the treatment of eltrombopag, and Weeks 1, 2, 3, 4 and 26 after treatment discontinuation. As this study was the first Japanese phase II study in which this product was administered in combination with ATG/CsA to subjects with naive moderate or more severe AA, the subject number of this study was determined to be 10 based on the feasibility survey.

Detailed description:

Arms: arm 1: Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag wasadministered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26.After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion.
Interventions: intervention 1: Eltrombopag intervention 2: Rabbit ATG intervention 3: CsA
Intervention descriptions: intervention 1: Eltrombopag was provided as white round film-coated tablets containing 12.5 mg or 25 mg of eltrombopag free acid (SB-497115-GR, eltrombopag). intervention 2: Rabbit ATG, as an intravenous drip infusion, diluted by 500 mL of saline or 5% glucose injection was administered at a dose of 2.5 to 3.75 mg per kg per day as a slow intravenous infusion over 6 hours. intervention 3: CsA as capsules, oral solution, or fine granule, was administered at a dose of 3 mg per kg twice a day.

Protocol documents:
Clinical trial NCT02450526
Conditions: Glabellar Lines
Sponsor: Ipsen
Start date: 2015-04-01; Completion date: 2017-09-06
Enrollment: 520 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate the efficacy of Dysport for the improvement in appearance of moderate to severe glabellar lines and to assess the short term and long term safety of Dysport, used for the improvement in appearance of moderate to severe glabellar lines in Chinese subjects.

Detailed description:
The first treatment cycle will be double blind and subjects will be randomised to receive Dysport, Botox or placebo. After the first treatment cycle, all subjects will receive a maximum of four treatment cycles with Dysport, occurring at intervals of no less than 84 Days (12 weeks) between each treatment cycle, depending upon individual duration of response to Dysport treatment.

Arms: arm 1: Dysport, 50 Units, divided into five injections into the glabellar area. Administered in double blind fashion at cycle 1 followed by up to 4 cycles Dysport, 50 Units administered with an interval period depending on response, no less than 12 weeks between each treatment cycle. arm 2: Botox will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area. arm 3: Dysport placebo will be administered in treatment cycle 1 only. On Day 1, 50 Units, divided into five injections into the glabellar area. arm 4: Botox placebo will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area.
Interventions: intervention 1: Botulinum toxin type A intervention 2: Botulinum toxin type A intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: 50 Units intervention 4: 20 Units

Protocol documents:
Clinical trial NCT00375674
Conditions: Kidney Neoplasms
Sponsor: Pfizer
Start date: 2007-08-01; Completion date: 2017-09-07
Enrollment: 674 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sunitinib malate intervention 2: Placebo
Intervention descriptions: intervention 1: sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent. intervention 2: Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent

Protocol documents:
Clinical trial NCT02944461
Conditions: Acne
Sponsor: Derm Research, PLLC
Start date: 2016-10-01; Completion date: 2017-09-11
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

Detailed description:
This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.

Arms: arm 1: Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.
Interventions: intervention 1: Dapsone 7.5 % gel
Intervention descriptions: intervention 1: Dapsone gel 7.5% applied once daily to truncal acne

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01336621
Conditions: Epilepsy
Keywords: Partial-onset seizures retigabine IR Open Label Extension GW582892 Epilepsy
Sponsor: GlaxoSmithKline
Start date: 2011-02-21; Completion date: 2017-09-13
Enrollment: 98 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase III study is to assess the long-term safety, tolerability and efficacy of flexibly dosed retigabine Immediate Release (IR) as adjunctive therapy in adult subjects with partial-onset seizures. In addition, those subjects who successfully completed 20 weeks of adjunctive treatment with retigabine IR in the parent study, RGB113905, and who were thought to have benefitted from treatment will be provided continued access to retigabine IR.

Detailed description:
RTG113413 is an open-label, multicentre extension study of RGB113905. This study will enroll adult subjects with partial-onset seizures (POS) who successfully completed 20 weeks of adjunctive treatment with retigabine IR (4-weeks Titration Phase and 16-weeks Flexible Dose Evaluation Phase) in the parent study, RGB113905 and who were thought to have benefitted from the treatment.

The Screening Visit (Visit 1) will be performed on the same day as the final visit of the parent study (Visit 7/Week 20). Subjects entering the extension study will initially receive the same dose of retigabine IR and concurrent antiepileptic drug (AED) as they were receiving on the final visit of the parent study. After the first week of the extension study, the subject's retigabine dose can be adjusted based on efficacy and tolerability. The overall daily dose of retigabine IR must be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum). In addition, the dose and the number of concurrent AEDs can be adjusted to meet the individual needs of the subject. Retigabine IR monotherapy is not permitted. If concurrent AED therapy is removed, the subject must be withdrawn from the study.

Subjects in this study will be eligible to receive retigabine IR treatment until one of the following criteria have been met: 1) regulatory approval and commercial availability of retigabine IR or 2) retigabine IR is not approved by the regulatory authorities or 3) the study is terminated by the sponsor for reasons including, but not limited to, safety issues or 4) subject is withdrawn or withdraws consent or 5) subject has received retigabine IR treatment for a total of 3 years and options i-iv have not been met. After the Screening Visit, subjects will be required to attend 4 further clinic visits at Weeks 13, 26, 39, and 52 in the first year of the study and a total of 3 clinic visits at approximately 4-monthly intervals during each of the second and third year of study. Upon completion or early withdrawal, subjects will begin a 3-week taper period and then return for a follow-up visit.

Arms: arm 1: Open label flexible dose between 300 mg/day (Minimum) and 1200 mg/day (maximum).
Interventions: intervention 1: Retigabine IR
Intervention descriptions: intervention 1: Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum)

Protocol documents: