ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01597908
Conditions: Melanoma
Keywords: BRAF inhibitor Metastatic Melanoma Cancer MEK inhibitor
Sponsor: Novartis Pharmaceuticals
Start date: 2012-06-04; Completion date: 2019-04-25
Enrollment: 704 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

Detailed description:
Screening/Subject eligibility: Subjects with histologically confirmed cutaneous melanoma that was either unresectable or metastatic (Stages IIIC or IV), were screened for eligibility. Eligible subjects were BRAF V600E or V600K mutation positive. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed.

Randomization: A total of 704 subjects were randomized in a ratio of 1:1 to receive combination therapy (352 subjects) or vemurafenib treatment (352 subjects). Subjects were stratified by LDH level (\> the ULN versus =\< ULN) and BRAF mutation (V600E versus V600K).

Study treatment: Dabrafenib and trametinib were administered orally at their recommended doses of 150 mg b.i.d. and 2.0 mg once daily, respectively. Subjects randomized in the combination therapy arm received both the agents. Subjects randomized in the vemurafenib arm received vemurafenib at the recommended dose of 960 mg orally b.i.d. Subjects in both the arms continued treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent. The protocol was amended on 07-Aug-2014 which allowed subjects who were still receiving vemurafenib to cross over to the dabrafenib and trametinib combination arm, including those subjects who were still receiving vemurafenib monotherapy treatment after disease progression. A washout period of a minimum of 7 days was considered prior to initiating dabrafenib in combination with trametinib. Subjects who experienced disease progression on the vemurafenib monotherapy arm, discontinued vemurafenib monotherapy, and subsequently received another anticancer therapy were ineligible for cross over to the dabrafenib and trametinib combination arm.

Follow-up/Study closure: After study treatment discontinuation, subjects were followed for survival and disease progression as applicable. This study completed once all the subjects had at least the 5-years of follow-up.

Arms: arm 1: BRAF inhibitor plus MEK inhibitor arm 2: BRAF inhibitor
Interventions: intervention 1: Dabrafenib intervention 2: Vemurafenib intervention 3: Trametinib
Intervention descriptions: intervention 1: Dabrafenib 150 mg twice daily orally intervention 2: Vemurafenib 960 mg twice daily orally intervention 3: Trametinib 2 mg once daily orally

Protocol documents:
Clinical trial NCT02101268
Conditions: Primary Myelofibrosis (PMF) Post-polycythemia Vera (Post-PV) Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Sponsor: Sierra Oncology LLC - a GSK company
Start date: 2014-06-19; Completion date: 2019-04-25
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to determine the efficacy of momelotinib (MMB) versus best available therapy (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24).

Participants will be randomized to receive either MMB or BAT for 24 weeks during the randomized treatment phase, after which they will be eligible to receive MMB in an extended treatment phase for up to an additional 204 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those subjects planning to continue treatment with MMB following the end of the study, the End of Treatment, 30-day, 12-Week, and survival follow-up visits are not required.

Detailed description:

Arms: arm 1: Participants will receive open-label momelotinib for 24 weeks during the randomized treatment phase, after which they will be eligible to receive momelotinib in an extended treatment phase for up to an additional 204 weeks. arm 2: Participants in the BAT treatment arm will receive open-label treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may be changed at any time during the study except during the screening period. After completion of the randomized treatment phase, participants will be eligible to receive momelotinib for the duration of the study during the extended treatment phase for up to 204 weeks.
Interventions: intervention 1: Momelotinib intervention 2: Best Available Therapy (BAT)
Intervention descriptions: intervention 1: Momelotinib tablet administered orally once daily intervention 2: Regimens for BAT may include but are not limited to chemotherapy (eg hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgen, interferon, and may include no myelofibrosis treatment.

Protocol documents:
Clinical trial NCT02093351
Conditions: Solid Tumours
Keywords: oncology, cancer, tumour, neoplasm, anticancer drug, pharmacokinetics, olaparib, anastrozole, tamoxifen, letrozole,
Sponsor: AstraZeneca
Start date: 2014-09-01; Completion date: 2019-04-29
Enrollment: 79 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible) continued access to olaparib after the PK phase and will provide additional safety data.

Detailed description:

Arms: arm 1: Olaparib-alone Steady state PK, Tamoxifen-alone steady state PK, Combined olaparib and Tamoxifen steady state PK. arm 2: Olaparib-alone Steady state PK, Anastrozole-alone steady state PK, Combined olaparib and Anastrozole steady state PK. arm 3: Olaparib-alone Steady state PK, Letrozole-alone steady state PK, Combined olaparib and Letrozole steady state PK.
Interventions: intervention 1: Olaparib intervention 2: Tamoxifen intervention 3: Anastrozole intervention 4: Letrozole intervention 5: Pharmacokinetic sampling
Intervention descriptions: intervention 1: 2 x 150mg tablets, twice daily Day 1-5, and Day 27 onwards (Cohort 1), Day 20 onwards (Cohort 2) or Day 39 onwards (Cohort 3) intervention 2: 60mg Tamoxifen once daily, Day 10 - Day 13; 20mg Tamoxifen once daily, Day 14 - Day 31 intervention 3: 1mg Anastrozole once daily Day 10 - Day 24 intervention 4: 2.5mg Letrozole once daily Day 10 - Day 43 intervention 5: Blood sampling over 12-24 hour period for pharmacokinetic analysis

Protocol documents:
Clinical trial NCT00643565
Conditions: Sarcoma
Sponsor: Hoffmann-La Roche
Start date: 2008-07-29; Completion date: 2019-04-30
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.

Detailed description:

Arms: arm 1: Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles. arm 2: Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
Interventions: intervention 1: Standard chemotherapy intervention 2: bevacizumab [Avastin]
Intervention descriptions: intervention 1: As prescribed intervention 2: 7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle

Protocol documents:
Clinical trial NCT01198028
Conditions: Metastatic Skin Squamous Cell Carcinoma Recurrent Skin Squamous Cell Carcinoma
Sponsor: M.D. Anderson Cancer Center
Start date: 2011-03-10; Completion date: 2019-05-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well erlotinib works in treating participants with skin squamous cell carcinoma that has spread to other places in the body or has come back. Drugs used in chemotherapy, such as erlotinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the overall response rate with erlotinib in patients with locoregionally recurrent or metastatic squamous cell carcinoma of the skin (CSCC) that is not amenable to curative treatment.

SECONDARY OBJECTIVES:

I. To determine duration of response and duration of stable disease. II. To determine progression-free and overall survival. III. To determine safety and tolerability of erlotinib.

EXPLORATORY OBJECTIVES:

I. To correlate baseline expression of estimated glomerular filtration rate (EGFR), expression of markers of EGFR activation (such as phosphorylated \[p\] EGFR and pAKT) and related cell-signaling pathways, and EGFR mutation status with response to erlotinib therapy.

II. To determine the effects of erlotinib on relevant biomarkers of the EGFR pathway in tumor tissue and in normal skin, and to correlate with response to therapy.

III. To determine if there is a correlation between the development of erlotinib-induced skin rash and response to therapy.

OUTLINE:

Participants receive erlotinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 3 months for up to 2 years.

Arms: arm 1: Participants receive erlotinib PO QD in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01969838
Conditions: Primary Myelofibrosis Post-Polycythemia Vera Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis
Sponsor: Sierra Oncology LLC - a GSK company
Start date: 2013-12-06; Completion date: 2019-05-02
Enrollment: 432 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).

Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.

Detailed description:

Arms: arm 1: Participants will receive momelotinib plus placebo to match ruxolitinib. arm 2: Participants will receive ruxolitinib plus placebo to match momelotinib.
Interventions: intervention 1: Momelotinib intervention 2: Ruxolitinib intervention 3: Placebo to match momelotinib intervention 4: Placebo to match ruxolitinib
Intervention descriptions: intervention 1: Momelotinib tablet administered orally once daily intervention 2: Ruxolitinib tablets administered orally twice daily intervention 3: Placebo to match momelotinib tablets administered orally once daily intervention 4: Placebo to match ruxolitinib tablets administered orally twice daily

Protocol documents:
Clinical trial NCT02579382
Conditions: Chronic Hepatitis B
Keywords: HBV Hepatitis Liver Disease
Sponsor: Gilead Sciences
Start date: 2015-11-10; Completion date: 2019-05-03
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.

Detailed description:

Arms: arm 1: Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.

Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. arm 2: Main Study Phase:TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.

Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. arm 3: Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.

Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. arm 4: Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.

Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
Interventions: intervention 1: TDF intervention 2: Vesatolimod intervention 3: Placebo
Intervention descriptions: intervention 1: 300 mg tablets administered orally once daily intervention 2: Tablets administered orally once a week (every 7 days) for 12 doses intervention 3: Placebo administered orally once a week (every 7 days) for 12 doses

Protocol documents:
Clinical trial NCT04493281
Conditions: Healthy Adult Subjects
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2019-03-22; Completion date: 2019-05-09
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV) formulation of edaravone in the fasting state in healthy adult subjects

Detailed description:

Arms: arm 1: Healthy subjects were administered a single dose of Edaravone oral suspension arm 2: Healthy subjects were administered a single dose of Edaravone intravenous formulation
Interventions: intervention 1: MT-1186 intervention 2: MCI-186
Intervention descriptions: intervention 1: Oral suspension intervention 2: Intravenous formulation

Protocol documents:
Prot_000.pdf: 



































































































































SAP_001.pdf: