ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02951767
Conditions: Bladder Cancer
Keywords: anti-PD-L1 PD-L1 MPDL3280A PD-1 bladder cancer atezolizumab Tecentriq
Sponsor: Hoffmann-La Roche
Start date: 2014-05-31; Completion date: 2023-02-28
Enrollment: 119 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.

Detailed description:

Arms: arm 1: Participants with advanced disease who are treatment-naive for advanced urothelial carcinoma and cisplatin ineligible will receive atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Interventions: intervention 1: Atezolizumab
Intervention descriptions: intervention 1: Atezolizumab 1200 mg will be given by IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.

Protocol documents:
Clinical trial NCT00195091
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2003-12-01; Completion date: 2023-03-02
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with moderate to high risk primary breast cancer (Stage II with more than 4 lymph nodes involved with cancer) III or Stage IV (without evidence of disease) will take tetrathiomolybdate (TM) pills for two years.

The objectives of the study are to:

* Assess the safety and tolerability of tetrathiomolybdate in patients with breast cancer at high risk of tumor recurrence.
* Observe the disease-free survival of patients in this trial.
* Conduct background scientific experiments on tumor tissue and blood of patients in this study

Detailed description:
Patients with moderate to high risk primary breast cancer -Stage III, Triple negative (T= 4 cm N0, any N+), Stage IV (without evidence of disease) will take tetrathiomolydbate (TM) pills for two years.

Extension study 1 - If patients are shown to be copper depleted, they are given the option to continue to receive TM for an additional 2 years.

Extension study 2 - Open to patients who are stage 4 NED, 10 involved lymph nodes or triple negative molecular subtype and candidates will continue for months 49-72.

Extension study 3 - Open to patients who are stage 4 NED receiving a benefit from TM. These subjects can continue receiving TM for 73-96 months.

Extension study 4 - Open to patients who are stage 4 NED receiving a benefit from TM. These subject can continue receiving TM for 97-120 months.

Arms: arm 1: Induction period - TM 40 mg is administered three x per day with meals and TM 60 mg at bedtime for a total of 4 doses (180 mg) per day.

Maintenance Period - Total TM dose per day will be in 20 mg increments to tailor the therapy to individualized patient needs to maintain the Cp level at 5-17mg/dL. Thus all dose modifications will be dependent on individual patient Cp levels. TM 40 mg p.o. BID with meals and TM 20 mg at bedtime. Subjects who have no evidence of disease (NED) and are receiving a benefit of TM can continue taking the drug for up to 120 months.
Interventions: intervention 1: Tetrathiomolybdate
Intervention descriptions: intervention 1: Induction with Tetrathiomolybdate (TM) Tetrathiomolybdate 40 mg. p.o. TID with meals and tetrathiomolybdate 60 mg at bedtime for a total of 4 doses (180 mg) per day.

Induction goal Total tetrathiomolybdate dose per day = 180 mg until serum ceruloplasmin (Cp) level decreases to 5-15mg/dL.

When target Cp window is reached, then the maintenance phase begins.

Maintenance with Tetrathiomolybdate Total tetrathiomolybdate dose per day = 100 mg

Tetrathiomolybdate 40 mg p.o. BID with meals and tetrathiomolybdate 20 mg at bedtime.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT05677867
Conditions: Overweight Obesity
Keywords: PF-07081532
Sponsor: Pfizer
Start date: 2023-01-18; Completion date: 2023-03-14
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the amount of PF-07081532 in blood after taking two different forms of PF-07081532. This study is seeking participants who are at least 18 years of age and are overweight and/or obese. All study participants will receive a total of 2 single doses of this study medication in either form. Form A consists of a PF-07081532 20 mg immediate release tablet and a PF-07081532 60 mg immediate release tablet. Form B consists of a PF-07081532 80 mg immediate release tablet. Each single dose will be separated by a minimum of 6 days. The amount of PF-07081532 in the blood for 4 days after taking each single dose will be compared between the two different formulations of PF-07081532.

The total time that participants will take part in this study is about 70 days. The first visit is a screening visit to ensure that participants are appropriately qualified for the study. This will occur up to 28 days before the first single dose. Participants will be admitted into the clinic one day prior to the first single dose and will remain in the clinic for a total of 11 days. The study team will phone the participants 28 to 35 days after the last dose of study medication.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Formulation A (PF-07081532 20 mg plus 60 mg) intervention 2: Formulation B (PF-07081532 80 mg)
Intervention descriptions: intervention 1: Formulation A: administered as a 20 mg immediate release tablet and a 60 mg immediate release tablet intervention 2: Formulation B: administered as a 80 mg immediate release tablet

Protocol documents:
Prot_000.pdf: 















































































































































































SAP_001.pdf:
Clinical trial NCT01924533
Conditions: Gastric Cancer
Sponsor: AstraZeneca
Start date: 2013-09-03; Completion date: 2023-03-27
Enrollment: 525 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.

Detailed description:
A randomized, double-blinded, multicentre phase III study to access the efficacy and safety of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in Asian patients with advanced gastric cancer (including gastro-oesophageal junction) who have progressed following first line therapy.

Arms: arm 1: olaparib + paclitaxel arm 2: placebo+ paclitaxel
Interventions: intervention 1: Olaparib intervention 2: Paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily. intervention 2: IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule. intervention 3: Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.

Protocol documents:
Clinical trial NCT01665144
Conditions: Secondary Progressive Multiple Sclerosis
Keywords: Secondary Progressive Multiple Sclerosis
Sponsor: Novartis Pharmaceuticals
Start date: 2012-12-20; Completion date: 2023-03-31
Enrollment: 1651 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

Detailed description:
This study had two parts, a Core Part and an Extension Part. The Core Part of the study was a randomized, multicenter, double-blind, placebo-controlled parallel-group study in patients with secondary progressive multiple sclerosis (SPMS). Eligible patients were randomized (2:1) to receive either siponimod or placebo. The duration of the Core Part of the study was variable for each patient, given that this was an event-driven study and terminated when a pre-defined number of confirmed disability progression (CDP) events had occurred irrespective of duration of individual patient participation. Patients who had 6-month CDP during the Treatment Epoch of the Core Part were provided with options that included starting treatment with open label siponimod as rescue medication.

Patients who were eligible to enter the Extension Part received open label siponimod.

Arms: arm 1: Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on the treatment epoch for 3 months. During the Core Part of the study, participants participated in a maximum of 3 epochs. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312. arm 2: Matching placebo to BAF312 was administered orally during the Core Part of the trial. Following the Core Part, eligible participants enter the Extension Part during which all receive open-label BAF312.
Interventions: intervention 1: BAF312 intervention 2: Placebo
Intervention descriptions: intervention 1: 0.25, 0.5, 1, and 2 mg film-coated tablets intervention 2: Film-coated tablets

Protocol documents: