ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01716715
Conditions: Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2012-11-06; Completion date: 2019-02-09
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the activity of cabozantinib (cabozantinib-s-malate) relative to weekly paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer with a log-rank test assessing progression-free survival (PFS) at 3.68 months (approximately pre-cycle 5) and 7.36 months (approximately pre-cycle 9).

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE).

II. To estimate and compare the proportion of patients responding to therapy by Response Evaluation Criteria for Solid Tumors (RECIST), cancer antigen 125 (CA125) response, the overall survival (OS), and the duration of response in each arm.

TERTIARY OBJECTIVES:

I. To retrospectively correlate c-met proto-oncogene (MET) expression with overall outcome.

II. To retrospectively correlate c-MET copy number with overall outcome.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28.

ARM II: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive cabozantinib-s-malate PO QD on days 1-28. arm 2: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.
Interventions: intervention 1: Cabozantinib S-malate intervention 2: Laboratory Biomarker Analysis intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Given IV

Protocol documents:
Clinical trial NCT01719380
Conditions: Colorectal Cancer
Keywords: Open-label dose escalation BRAF inhibitor LGX818 PI3K inhibitor BYL719 EGFR cetuximab metastatic colorectal cancer KRAS BRAF V600
Sponsor: Pfizer
Start date: 2012-11-23; Completion date: 2019-02-12
Enrollment: 156 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LGX818 intervention 2: Cetuximab intervention 3: BYL719
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01212991
Conditions: Prostate Cancer
Keywords: Progressive Metastatic Prostate Cancer
Sponsor: Pfizer
Start date: 2010-09-16; Completion date: 2019-02-14
Enrollment: 1717 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Enzalutamide intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal. intervention 2: Participants received placebo, administered as four capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.

Protocol documents:
Clinical trial NCT02038452
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: hand wrist carpal tunnel syndrome pragmatic randomised steroid splint
Sponsor: Keele University
Start date: 2014-04-01; Completion date: 2019-02-26
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Carpal Tunnel Syndrome (CTS) is a common condition in which a nerve (known as the median nerve) is squeezed where it passes through the wrist. It can cause pain or aching, tingling or numbness in the affected hand. It may disturb sleep, or affect ability to do day to day things.

There have been several studies into the best treatment of patients with severe symptoms of CTS who are referred to a hospital for treatment. However, little is known about the best treatments for patients with mild to moderate symptoms who visit their GP but do not require hospital treatment.

The study will investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term (6 weeks) compared to a night splint in people consulting with mild to moderate CTS in primary care.We will study the effects of these 2 treatments over 6 weeks and at 6 months. Subject to further funding, the Study will also look at whether these 6 weeks of treatment are effective 1 year and 2 years later.

The study will take place in up to 50 GP practices and hospital clinics across the UK. Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks will be eligible for inclusion.

The steroid is a drug called "DepoMedrone." This drug is already widely used to treat CTS. In this study, one injection will be given. The splint is made of elastic and has an aluminium bar which sits on the palm of the hand. In this study, the splint will be worn at night for 6 weeks. Each participant will receive either a single steroid injection or a splint, and will be asked to complete up to 5 questionnaires over 2 years.

Detailed description:

Arms: arm 1: Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg) arm 2: Wrist splint to be worn at night
Interventions: intervention 1: Depo-Medrone intervention 2: Wrist Splint
Intervention descriptions: intervention 1: Steroid Injection intervention 2: Simple wrist splint

Protocol documents:
Clinical trial NCT02397694
Conditions: HIV-1 Infection
Keywords: Adult HIV naive
Sponsor: Gilead Sciences
Start date: 2015-03-23; Completion date: 2019-02-27
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.

Detailed description:

Arms: arm 1: Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks.

* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF. arm 2: Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks.

* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF. arm 3: After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF.
Interventions: intervention 1: BIC intervention 2: F/TAF intervention 3: DTG intervention 4: BIC Placebo intervention 5: DTG Placebo intervention 6: B/F/TAF
Intervention descriptions: intervention 1: 75 mg tablet administered orally once daily intervention 2: 200/25 mg FDC tablet administered orally once daily intervention 3: 50 mg tablet administered orally once daily intervention 4: Tablet administered orally once daily intervention 5: Tablet administered orally once daily intervention 6: 50/200/25 mg FDC tablet administered orally once daily

Protocol documents:
Clinical trial NCT02579616
Conditions: Biliary Tract Cancer
Keywords: Lenvatinib E7080 Unresectable biliary tract cancer BTC Gemcitabine-based combination chemotherapy Lenvima
Sponsor: Eisai Co., Ltd.
Start date: 2015-10-23; Completion date: 2019-02-27
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase that will last within 21 days; a Treatment phase that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks; and a Follow-up phase that will begin immediately after the Off-Treatment Visit and will continue as long as the participant is alive, unless the participant withdraws consent, or until the End of Study.

Detailed description:

Arms: arm 1: Participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum agent/fluoropyrimidine agent).
Interventions: intervention 1: Lenvatinib
Intervention descriptions: intervention 1: Lenvatinib will be administered orally once daily in 28-day cycles. Participants will be treated until disease progression, unacceptable toxicity, withdrawal of consent, participant's choice, etc.

Protocol documents:
Clinical trial NCT01584648
Conditions: Melanoma
Keywords: Randomized study combination therapy BRAF inhibitor GSK1120212 BRAF V600E/K mutation-positive cutaneous melanoma trametinib GSK2118436 MEK inhibitor Phase III dabrafenib
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-04; Completion date: 2019-02-28
Enrollment: 423 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. 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. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

Detailed description:
Dabrafenib and trametinib was administered orally at their recommended monotherapy doses of 150 mg b.i.d and 2 mg q.d., respectively. Subjects in the combination therapy arm received both agents; subjects in the dabrafenib monotherapy arm received dabrafenib and placebo. Treatment was continued in both arms until disease progression, death, unacceptable toxicity, or withdrawal of consent.

After treatment discontinuation, subjects were followed for survival and disease progression as applicable to collect data for the secondary objective of overall survival (OS).

Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.

Arms: arm 1: Dabrafenib and Trametinib combination arm 2: Dabrafenib and Trametinib placebo
Interventions: intervention 1: Dabrafenib intervention 2: Trametinib intervention 3: Trametinib placebo
Intervention descriptions: intervention 1: Dabrafenib 150 mg twice daily intervention 2: Trametinib 2 mg once daily intervention 3: Dabrafenib 150 mg twice daily and trametinib placebo

Protocol documents:
Clinical trial NCT02121795
Conditions: HIV-1 Infection
Keywords: HIV HIV-1 Positive Virologically-suppressed
Sponsor: Gilead Sciences
Start date: 2014-05-06; Completion date: 2019-03-01
Enrollment: 668 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF.

This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.

Detailed description:

Arms: arm 1: Participants will receive F/TAF (200/25 mg or 200/10 mg) plus FTC/TDF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks. Dosing of F/TAF will be dependent on the third agent of the participants' pre-existing treatment regimen. arm 2: Participants will receive FTC/TDF plus F/TAF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks.
Interventions: intervention 1: FTC/TDF intervention 2: F/TAF intervention 3: Allowed third antiretroviral agent intervention 4: FTC/TDF Placebo intervention 5: F/TAF Placebo
Intervention descriptions: intervention 1: 200/300 mg FDC tablets administered orally once daily intervention 2: Tablets administered orally once daily intervention 3: An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®). intervention 4: Tablets administered orally once daily intervention 5: Tablets administered orally once daily

Protocol documents:
Clinical trial NCT00121719
Conditions: Solid Tumor or Lymphoma
Keywords: Resistant and refractory solid tumors lymphomas hodgkins disease non-hodgkins lymphoma neoplasms
Sponsor: Eisai Inc.
Start date: 2005-07-01; Completion date: 2019-03-01
Enrollment: 82 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in patients with solid tumors or lymphomas.

Detailed description:
This is an open-label, non-randomized, dose escalation study. Patients will be treated with lenvatinib once daily. Each four-week treatment period will be considered to be one treatment cycle. The selection of subsequent dose levels will be performed according to an accelerated design: Although initially 3 patients per dose level will be entered, the next dose level can be opened for patient accrual after only the first patient in the previous cohort completes Cycle 1 with no drug-related toxicity greater than grade 1 (except alopecia, lymphopenia and anemia).

Arms: arm 1: None
Interventions: intervention 1: Lenvatinib
Intervention descriptions: intervention 1: Lenvatinib tablets taken orally, once daily.

Protocol documents:
Clinical trial NCT00828672
Conditions: Locally Advanced Rectal Cancer
Keywords: bevacizumab capecitabine radiation therapy oxaliplatin multimodality treatments TME (total mesorectal excision) Axe Beam rectal cancer neoadjuvant pathological complete response postoperative complications
Sponsor: Universitaire Ziekenhuizen KU Leuven
Start date: 2009-06-01; Completion date: 2019-03-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.

To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

Detailed description:
See Synopsis

Arms: arm 1: Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. arm 2: Bevacizumab and Capecitabine concurrently with radiotherapy
Interventions: intervention 1: Oxaliplatin intervention 2: Bevacizumab intervention 3: Capecitabine intervention 4: radiotherapy
Intervention descriptions: intervention 1: Administered on days 15,22,29,36 en 43; 50 mg/m2 intervention 2: Administered on days 1,15,29 and 43 ; 5mg/kg intervention 3: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy intervention 4: Total dose 45Gy

Protocol documents:
Clinical trial NCT01546038
Conditions: Acute Myeloid Leukemia
Keywords: Hedgehog Inhibitor Acute Myeloid Leukemia Myelodysplastic syndrome Intensive chemotherapy LDAC glasdegib
Sponsor: Pfizer
Start date: 2012-06-27; Completion date: 2019-03-04
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.

Detailed description:

Arms: arm 1: PF-04449913 in combination with low dose ARA-C (LDAC) arm 2: PF-04449913 in combination with Decitabine arm 3: PF-04449913 in combination with intensive chemotherapy: PF-04449913 administered continuously for 28 days. Daunorubicin given using 60 mg/m2 for 3-days together with cytarabine 100 mg/m2 on days 1 through 7 followed by cytarabine 1g/m2 on days 1, 3, and 5 during 2-4 cycles of consolidation therapy. arm 4: PF-04449913 in combination with intensive chemotherapy: PF-04449913 administered continuously for 28 days. Daunorubicin given using 60 mg/m2 for 3-days together with cytarabine 100 mg/m2 on days 1 through 7 followed by cytarabine 1g/m2 on days 1, 3, and 5 during 2-4 cycles of consolidation therapy. arm 5: Patients will be randomized 2:1 (low dose ARA-C in combination with PF-04449913: low dose ARA-C alone).
Interventions: intervention 1: PF-04449913 intervention 2: Low dose ARA-C (LDAC) intervention 3: PF-04449913 intervention 4: Decitabine intervention 5: PF-04449913 intervention 6: Daunorubicin intervention 7: Cytarabine intervention 8: PF-04449913 intervention 9: Daunorubicin intervention 10: Cytarabine intervention 11: PF-04449913 intervention 12: Low dose ARA-C (LDAC)
Intervention descriptions: intervention 1: PF-04449913 administered orally and continuously for 28-days. intervention 2: Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10. intervention 3: PF-04449913 administered orally and continuously for 28 days. intervention 4: Decitabine given at 20 mg/m2 over 1 hour infusion for 5-days intervention 5: PF-04449913 administered orally and continuously for 28 days intervention 6: Daunorubicin given using 60 mg/m2 for 3-days intervention 7: Cytarabine 100 mg/m2 on days 1 through 7 intervention 8: PF-04449913 administered orally and continuously for 28 days intervention 9: Daunorubicin given using 60 mg/m2 for 3-days intervention 10: Cytarabine 100 mg/m2 on days 1 through 7 intervention 11: PF-04449913 administered orally and continuously for 28 days (if randomized to receive PF-04449913) intervention 12: Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.

Protocol documents:
Clinical trial NCT00313170
Conditions: Advanced Breast Cancer Metastatic Breast Cancer
Keywords: oncology cancer breast cancer
Sponsor: AstraZeneca
Start date: 2006-05-30; Completion date: 2019-03-13
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.

Detailed description:

Arms: arm 1: Fulvestrant 250 mg (intramuscular injection 250 mg) arm 2: Fulvestrant 250 mg (+ 250 mg loading regimen) arm 3: Fulvestrant 500 mg (intramuscular injection 500 mg)
Interventions: intervention 1: Fulvestrant
Intervention descriptions: intervention 1: intramuscular injection 250 mg \& 500 mg

Protocol documents: