ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00457691
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal neoplasms
Sponsor: Pfizer
Start date: 2007-06-01; Completion date: 2010-03-01
Enrollment: 768 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.

Detailed description:
On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 5 fluorouracil intervention 2: irinotecan intervention 3: levo- leucovorin intervention 4: sunitinib intervention 5: 5 fluorouracil intervention 6: irinotecan intervention 7: levo- leucovorin intervention 8: placebo
Intervention descriptions: intervention 1: 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days intervention 2: 180mg/m2 iv day 1 every 14 days intervention 3: 200mg/m2 iv; day 1 every 14 days intervention 4: 37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period intervention 5: 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days intervention 6: 180mg/m2 iv day 1 every 14 days intervention 7: 200mg/m2 iv; day 1 every 14 days intervention 8: 37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period

Protocol documents:
Clinical trial NCT00552240
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2007-09-01; Completion date: 2010-03-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).

Detailed description:

Arms: arm 1: after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks arm 2: patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
Interventions: intervention 1: tenofovir DF 300 mg QD intervention 2: tenofovir DF 300 mg QD intervention 3: emtricitabine 200 mg QD intervention 4: emtricitabine 200 mg QD intervention 5: Nevirapine 200 mg BID intervention 6: Atazanavir 300 mg intervention 7: Ritonavir 100 mg
Intervention descriptions: intervention 1: 300 mg QD intervention 2: 300 mg QD intervention 3: 200 mg QD intervention 4: 200 mg QD intervention 5: 200 mg BID intervention 6: 300 mg QD intervention 7: 100 mg QD

Protocol documents:
Clinical trial NCT00578786
Conditions: Pulmonary Arterial Hypertension
Sponsor: Gilead Sciences
Start date: 2004-02-01; Completion date: 2010-03-01
Enrollment: 383 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
AMB-320/321-E was designed to provide long-term, controlled monitoring of pulmonary arterial hypertension (PAH) patients treated with ambrisentan (AMB) in order to properly define the adverse event profile associated with this endothelin receptor antagonist (ERA), including the incidence and severity of elevated serum liver function tests (LFTs). In addition, this study continued the efficacy assessments of the previous studies, examined long-term AMB treatment success, and compared long-term survival of subjects treated with AMB to the NIH registry of patients with PAH.

Detailed description:
AMB-320 (ARIES-1; NCT00423748) and AMB-321 (ARIES-2; NCT00423202) were 12-week, Phase 3, randomized, double-blind, placebo-controlled, multicenter, efficacy studies of AMB in subjects with PAH. The objectives of these studies were to determine the effect of three doses of AMB (2.5, 5.0, and 10.0 mg) on exercise capacity, as well as several clinical measures of PAH. The current study (NCT00578786) was unblinded (by design) prior to completion. The ARIES studies were identical except for the dose groups assessed and the geographic locations where the studies were conducted. Both studies evaluated placebo and 5.0-mg AMB dose groups; however, AMB-320 (NCT00423748) also examined an AMB dose of 10.0 mg, while AMB-321 (NCT00423202) included an AMB dose of 2.5 mg. AMB-320/321-E was an optional study for subjects who had participated in AMB-320 (NCT00423748) or AMB-321 (NCT00423202) that allowed continued long-term treatment with AMB.

Arms: arm 1: 2.5, 5 or 10 mg ambrisentan
Interventions: intervention 1: ambrisentan
Intervention descriptions: intervention 1: 2.5, 5.0 or 10.0 mg ambrisentan po, qd, long-term

Protocol documents:
Clinical trial NCT00699283
Conditions: Epilepsy
Keywords: Epilepsy; Monotherapy Partial Onset Seizures Adults and Adolescents
Sponsor: UCB Pharma
Start date: 2008-08-01; Completion date: 2010-03-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.

Detailed description:

Arms: arm 1: 50 mg daily arm 2: 100 mg daily
Interventions: intervention 1: Brivaracetam intervention 2: Brivaracetam
Intervention descriptions: intervention 1: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study) intervention 2: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)

Protocol documents:
Clinical trial NCT00700622
Conditions: Diabetes, Type 1
Sponsor: Mannkind Corporation
Start date: 2008-05-01; Completion date: 2010-03-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

Detailed description:

Arms: arm 1: Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine) arm 2: Humalog (insulin lispro) in combination with Lantus (insulin glargine)
Interventions: intervention 1: Technosphere Insulin intervention 2: Insulin glargine intervention 3: Insulin lispro
Intervention descriptions: intervention 1: Technosphere Insulin Inhalation Powder 15U or 30U intervention 2: Lantus-injectible supplied as 3mL (300 units) pens intervention 3: Humalog autopen cartridges pre-filled with 3mL (300 units)

Protocol documents:
Clinical trial NCT00863798
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2009-04-01; Completion date: 2010-03-01
Enrollment: 682 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Desvenlafaxine Succinate Sustained-Release 10mg intervention 2: Desvenlafaxine Succinate Sustained-Release 50 mg intervention 3: placebo
Intervention descriptions: intervention 1: 10 mg tablet, once daily dosing for 8 weeks intervention 2: 50 mg tablet, once daily dosing for 8 weeks intervention 3: Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Protocol documents:
Clinical trial NCT00900731
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD indacaterol beta 2 agonist tiotropium
Sponsor: Novartis Pharmaceuticals
Start date: 2009-06-01; Completion date: 2010-03-01
Enrollment: 1598 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

Detailed description:

Arms: arm 1: Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. arm 2: Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
Interventions: intervention 1: Indacaterol 150 μg intervention 2: Tiotropium 18 μg intervention 3: Placebo to indacaterol intervention 4: Placebo to tiotropium
Intervention descriptions: intervention 1: Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 2: Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®). intervention 3: Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 4: Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).

Protocol documents:
Clinical trial NCT00003644
Conditions: Ovarian Cancer
Keywords: stage I ovarian epithelial cancer stage II ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma ovarian serous cystadenocarcinoma ovarian mucinous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma Brenner tumor
Sponsor: Gynecologic Oncology Group
Start date: 1998-10-01; Completion date: 2010-03-01
Enrollment: 571 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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 whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.

Detailed description:
OBJECTIVES:

* Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel.
* Assess the frequency and severity of toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks.
* Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.

Arms: arm 1: carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later arm 2: carboplatin, paclitaxel
Interventions: intervention 1: carboplatin intervention 2: paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00006389
Conditions: Stage III Gastric Cancer Stage IV Gastric Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2000-10-01; Completion date: 2010-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.

Detailed description:
OBJECTIVES:

I. Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin.

II. Determine the toxic effects of this regimen in these patients. III. Determine the molecular determinants of response to this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: bryostatin 1 intervention 2: cisplatin intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00025155
Conditions: Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2002-07-01; Completion date: 2010-03-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE:

Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
Interventions: intervention 1: ixabepilone
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00057863
Conditions: Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma Stage IVA Cervical Cancer Stage IVB Cervical Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2003-01-01; Completion date: 2010-03-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in treating patients who have locally recurrent or metastatic cervical cancer. 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.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective response rates for the combination of paclitaxel and oxaliplatin in patients with metastatic or locally recurrent cervical cancer.

II. To determine the toxicities and recovery from toxicities of patients with cervical cancer receiving paclitaxel and oxaliplatin.

OUTLINE:

Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed ever 3 months.

Arms: arm 1: Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Paclitaxel intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00068380
Conditions: Recurrent Gastric Cancer Stage IV Gastric Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-03-01; Completion date: 2010-03-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate, time to tumor progression, and overall survival in patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy regimen for metastatic disease.

II. To assess the toxicities of STI571 in these patients. III. To obtain preliminary data on molecular correlates to determine clinical efficacy and toxicity.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk \[chemonaïve\] vs poor risk \[1 prior chemotherapy regimen\]).

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 1-1.5 years.

Arms: arm 1: Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: imatinib mesylate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00072189
Conditions: Recurrent Melanoma Stage IV Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2003-11-01; Completion date: 2010-03-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. This phase II trial is studying how well UCN-01 works in treating patients with metastatic melanoma.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the anti-tumor activity of UCN-01 (7-hydroxystaurosporine) in metastatic melanoma, as determined by the response rate.

II. To assess the clinical and laboratory toxicities of UCN-01. III. To study the effects of UCN-01 administration on potential markers of specific G1-phase cell cycle regulators.

OUTLINE: This is a multicenter study.

Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 17-33 patients will be accrued for this study within 18 months.

Arms: arm 1: Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: 7-hydroxystaurosporine intervention 2: laboratory biomarker analysis intervention 3: pharmacological study
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00077857
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2003-07-01; Completion date: 2010-03-01
Enrollment: 470 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m\^2 or 825 mg/m\^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.

Detailed description:

Arms: arm 1: 1250 mg/m\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\^2 intravenous on day 1 of each 3 week cycle. arm 2: 825 mg/m\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m\^2 intravenous on day 1 of each 3 week cycle.
Interventions: intervention 1: capecitabine (Xeloda®) intervention 2: docetaxel (Taxotere®)
Intervention descriptions: intervention 1: 825 mg/m\^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle. intervention 2: 75 mg/m\^2 intravenous on day 1 of each 3 week cycle

Protocol documents: