ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00250926
Conditions: Waldenstrom's Macroglobulinemia
Keywords: bortezomib dexamethasone rituximab
Sponsor: Dana-Farber Cancer Institute
Start date: 2005-10-01; Completion date: 2009-02-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if the combination of bortezomib (Velcade), dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's macroglobulinemia.

Detailed description:
* This is an open-label study which means both the patient and the doctor will know what drugs and doses the patient is receiving throughout the study.
* Patients will receive 8 cycles of study treatment with bortezomib, dexamethasone and rituximab. Each cycle is 21 days long. Therapy is given on the first, fourth, eighth and eleventh day of each cycle, followed by a 10 day rest period. The first 4 cycles will be given one after the other. Three months after completing the fourth cycle of therapy, patients will receive one cycle of therapy every three months for a total of four more cycles.
* On the first, fourth, eighth and eleventh day of each cycle, the patient will receive bortezomib and dexamethasone as an intravenous injection through a needle in your vein. On the eleventh day only, the patient will also receive rituximab as an intravenous infusion after getting bortezomib and dexamethasone.
* Prior to each infusion of rituximab therapy, the patient will be asked to take some medications to prevent or reduce side effects of rituximab. These medications are benadryl, tylenol, and possibly more steroids. The doctor will determine which of these drugs are appropriate for the individual patient.
* During the rituximab infusion, the patients blood pressure and pulse will be monitored frequently and the infusion rate may be decreased depending upon the side effects experienced.
* After therapy is completed, the patient will be followed every three months for 2 more years for office visits and laboratory tests to determine how well they are doing and if the therapy continues to benefit them.

Arms: arm 1: A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
Interventions: intervention 1: Bortezomib intervention 2: Dexamethasone intervention 3: Rituximab
Intervention descriptions: intervention 1: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles intervention 2: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles intervention 3: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles

Protocol documents:
Clinical trial NCT00254540
Conditions: Carcinoma, Renal Cell
Keywords: Ph2, RCC, SU011248, SUNITINIB
Sponsor: Pfizer
Start date: 2005-12-01; Completion date: 2009-02-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SU011248 capsule
Intervention descriptions: intervention 1: 50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops

Protocol documents:
Clinical trial NCT00275262
Conditions: Hodgkin Disease Lymphoma, Non-Hodgkin Multiple Myeloma Mantle Cell Lymphoma
Keywords: Bone marrow transplantation Hematopoietic stem cell transplantation Hodgkin's disease non-Hodgkin's lymphoma multiple myeloma
Sponsor: Abbott
Start date: 2006-02-01; Completion date: 2009-02-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 2 study, conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation.

Detailed description:
This Phase 2 study will be conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation. Patients will be randomized to receive either LAD 11.25 mg 3 Month treatment or placebo and all patients will be vaccinated with KLH 6 months posttransplant. Patients will be evaluated to determine if the rate of immunologic recovery in the LAD group is enhanced compared with the placebo group.

Arms: arm 1: Three intramuscular injections LAD 11.25 mg 3 Month treatment administered approximately 3 months apart. arm 2: Three intramuscular injections of matched placebo administered approximately 3 months apart.
Interventions: intervention 1: Leuprolide acetate depot (LAD) 11.25 mg 3 Month intervention 2: Matched placebo
Intervention descriptions: intervention 1: LAD intramuscular injection 11.25 mg, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6. intervention 2: Matched placebo intramuscular injection, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6.

Protocol documents:
Clinical trial NCT00283595
Conditions: Anorexia Nervosa Osteopenia Osteoporosis Eating Disorders
Keywords: Anorexia Nervosa Eating disorder Bone Growth hormone Osteopenia Osteoporosis
Sponsor: Massachusetts General Hospital
Start date: 2006-01-01; Completion date: 2009-02-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength.

We are investigating whether a hormone that is naturally produced by the human body, called growth hormone, can help strengthen the bones of women with this type of disordered eating.

Detailed description:
* Twelve week study
* Eight visits, six of which can be conducted at your home physician's office
* Two bone density scans
* Hormonal and nutritional evaluations

Arms: arm 1: Treatment with rHGH arm 2: Treatment with Placebo
Interventions: intervention 1: Recombinant Human Growth Hormone intervention 2: Placebo for Recombinant Human Growth Hormone
Intervention descriptions: intervention 1: Dosage increased in steps for first four weeks. Self injection qd x 12 weeks intervention 2: Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks

Protocol documents:
Clinical trial NCT00289991
Conditions: Antifungal Prophylaxis of Invasive Fungal Infections
Sponsor: Pfizer
Start date: 2006-03-01; Completion date: 2009-02-01
Enrollment: 489 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Itraconazole intervention 2: Vfend - voriconazole
Intervention descriptions: intervention 1: Prophylaxis intervention 2: Prophylaxis

Protocol documents:
Clinical trial NCT00291577
Conditions: Breast Neoplasms
Keywords: advanced sunitinib (Sutent) docetaxel Phase 1B
Sponsor: Pfizer
Start date: 2006-07-01; Completion date: 2009-02-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sunitinib (Sutent) intervention 2: Taxotere
Intervention descriptions: intervention 1: Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision intervention 2: Taxotere 75 mg/m2 iv, once every 3 weeks

Protocol documents:
Clinical trial NCT00300885
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: Non-Small Cell Lung Cancer NSCLC
Sponsor: Bayer
Start date: 2006-02-01; Completion date: 2009-02-01
Enrollment: 926 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.

Detailed description:

Arms: arm 1: Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle. arm 2: Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily\] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
Interventions: intervention 1: Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel intervention 2: Carboplatin plus Paclitaxel
Intervention descriptions: intervention 1: Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle. intervention 2: Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily\] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.

Protocol documents:
Clinical trial NCT00319254
Conditions: Breast Neoplasms Neoplasm Metastasis
Keywords: Advanced Breast Cancer
Sponsor: Pfizer
Start date: 2006-05-01; Completion date: 2009-02-01
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SKI-606 (Bosutinib)
Intervention descriptions: intervention 1: SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.

Protocol documents:
Clinical trial NCT00322374
Conditions: Metastatic Breast Cancer
Sponsor: R-Pharm
Start date: 2006-08-01; Completion date: 2009-02-01
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Detailed description:

Arms: arm 1: Participants received 25 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days. arm 2: Participants received 30 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days. arm 3: Participants received 35 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days.
Interventions: intervention 1: Ixabepilone intervention 2: Epirubicin
Intervention descriptions: intervention 1: Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study. intervention 2: Infusion, intravenous (IV): 75 mg/m\^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².

Protocol documents:
Clinical trial NCT00364845
Conditions: Anemia Chronic Kidney Disease
Keywords: Quality of Life Chronic Kidney Disease Anemia
Sponsor: Amgen
Start date: 2006-09-01; Completion date: 2009-02-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks

Detailed description:
This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.

Arms: arm 1: Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months. arm 2: Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Interventions: intervention 1: Darbepoetin alfa intervention 2: Placebo
Intervention descriptions: intervention 1: Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion. intervention 2: Prefilled syringe placebo, to match active arm

Protocol documents:
Clinical trial NCT00371761
Conditions: Hepatitis B, Chronic (CHB)
Keywords: Hepatitis B virus Pegylated interferon alfa-2b (PegIntron)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-09-01; Completion date: 2009-02-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open label, randomized, comparative, multi-center study. Subjects will be screened within 2 weeks prior to study entry to establish eligibility. Subjects who meet all the selection criteria will be randomly assigned 1:1 to (1) once-a-week, subcutaneous Pegylated interferon alfa-2b (PegIntron) (1.5 mcg/kg body weight) or (2) oral adefovir 10 mg daily. The treatment phase will be 24 weeks for PegIntron and 48 weeks for adefovir. All subjects completing the assigned treatment phase will be followed up for an additional 48 weeks for PegIntron and 24 weeks for adefovir as observation phase. The primary objective is to establish the efficacy profile of PegIntron. Secondary objectives are to compare the efficacy profile of PegIntron with that of adefovir, compare efficacy of PegIntron in lamivudine-naïve and lamivudine-experienced subjects, and to establish the safety profile of PegIntron in treating patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.

Detailed description:

Arms: arm 1: PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase arm 2: Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
Interventions: intervention 1: Pegylated interferon alfa-2b (PegIntron) intervention 2: Adefovir dipivoxil (adefovir)
Intervention descriptions: intervention 1: Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks intervention 2: 10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks

Protocol documents:
Clinical trial NCT00387426
Conditions: Accelerated Phase Chronic Myelogenous Leukemia Acute Undifferentiated Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blastic Phase Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia Chronic Phase Chronic Myelogenous Leukemia Mast Cell Leukemia Meningeal Chronic Myelogenous Leukemia Primary Myelofibrosis Progressive Hairy Cell Leukemia, Initial Treatment Prolymphocytic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia T-cell Large Granular Lymphocyte Leukemia Untreated Adult Acute Lymphoblastic Leukemia Untreated Adult Acute Myeloid Leukemia Untreated Hairy Cell Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2006-09-01; Completion date: 2009-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sunitinib works in treating patients with idiopathic myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells.

Detailed description:
PRIMARY OBJECTIVE:

I. Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate.

SECONDARY OBJECTIVE:

I. Assess the safety of sunitinib malate in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral sunitinib malate once daily for 6 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.

Arms: arm 1: Patients receive oral sunitinib malate once daily for 6 weeks.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT00395057
Conditions: Choroid Neovascularization Age-Related Macular Degeneration
Sponsor: Allergan
Start date: 2007-01-01; Completion date: 2009-02-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration

Detailed description:

Arms: arm 1: AGN 211745 Solution 1000 ug arm 2: AGN 211745 Solution 300 ug arm 3: AGN 211745 Solution 100 ug arm 4: Ranibizumab 500 ug
Interventions: intervention 1: AGN 211745 intervention 2: AGN 211745 intervention 3: AGN 211745 intervention 4: Ranibizumab 500µg
Intervention descriptions: intervention 1: AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2 intervention 2: AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2 intervention 3: AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2 intervention 4: Ranibizumab 500µg injections at Day 1, Month 1, Month 2

Protocol documents:
Clinical trial NCT00412750
Conditions: Hepatitis B
Keywords: hepatitis B hepatitis B Virus (HBV) chronic hepatitis B telbivudine peginterferon
Sponsor: Novartis
Start date: 2006-12-01; Completion date: 2009-02-01
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.

Detailed description:

Arms: arm 1: Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peginterferon alpha-2a (PEG-INF)180 μg subcutaneous injection once a week for 52 weeks. arm 2: Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks. arm 3: Peginterferon alpha-2a (PEG- INF) monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
Interventions: intervention 1: Telbivudine (LdT) intervention 2: peginterferon alpha-2a
Intervention descriptions: intervention 1: 600 mg orally once daily for 104 weeks. intervention 2: 180 μg subcutaneous injection once a week for 52 weeks.

Protocol documents:
Clinical trial NCT00413283
Conditions: Lung Cancer Chemotherapy-Induced Thrombocytopenia Non-Small Cell Lung Cancer Cancer Lung Neoplasms Oncology Solid Tumors Thrombocytopenia
Keywords: Advanced Non-Small Cell Lung Cancer Chemotherapy Induced Thrombocytopenia CIT NSCLC Stage IIIB NSCLC Stage IV NSCLC Gemcitabine Carboplatin Cisplatin
Sponsor: Amgen
Start date: 2006-12-01; Completion date: 2009-02-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.

Detailed description:

Arms: arm 1: Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. arm 2: Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. arm 3: Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice. arm 4: Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
Interventions: intervention 1: Romiplostim intervention 2: Placebo intervention 3: Gemcitabine intervention 4: Carboplatin intervention 5: Cisplatin
Intervention descriptions: intervention 1: Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. intervention 2: Placebo subcutaneous injection. intervention 3: Intravenous infusion intervention 4: Intravenous infusion intervention 5: Intravenous infusion

Protocol documents: