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NCT ID: NCT01953926 Terminated - Clinical trials for Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

SUMMIT
Start date: September 30, 2013
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.

NCT ID: NCT01953003 Completed - Clinical trials for Malignant Neoplasm of Breast

Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Start date: September 2013
Phase: Phase 3
Study type: Interventional

Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. Capecitabine currently has a role in this setting, yet as many as 80% of patients do not respond to this treatment and those who respond eventually develop clinical resistance. The antitumour activity of vinflunine has been demonstrated in patients with breast cancer after exposure to anthracycline and to taxane. Vinflunine plus capecitabine has been shown to be a feasible combination for patients previously treated with an anthracycline and a taxane. Each drug in combination can be administered at efficacious doses. This population has few therapeutic options with established clinical benefit. The development of a new regimen and potential new standard of care for this group is important. - Primary objective: • to compare in patients with advanced breast cancer pretreated with anthracycline and taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine alone, in terms of progression-free survival. - Secondary objectives: - to evaluate the response rate, the time to response and the duration of response in both arms - to compare the disease control rate between arms - to evaluate the duration of disease control in both arms - to evaluate the overall survival in both arms - to evaluate safety Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of 334 patients with advanced breast cancer who have previously been treated with an anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus capecitabine (Arm A) or capecitabine alone (Arm B).

NCT ID: NCT01951846 Completed - Clinical trials for Malignant Solid Tumour

To Determine the Maximum Tolerated Dose (MTD) of BIBF 1120 in Patients With Solid Tumours

Start date: November 2002
Phase: Phase 1
Study type: Interventional

The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events. Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics.

NCT ID: NCT01950572 Recruiting - Clinical trials for Pancreatic Neoplasms

Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Start date: September 9, 2013
Phase:
Study type: Observational

Background: - Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. - Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States. - The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis. - Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease. Objectives: -To allow sample acquisition for use in the study of mesothelioma. Eligibility: - All patients age greater than or equal to 2 years with malignant mesothelioma - Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18 Design: - Up to 1000 subjects will be enrolled. - Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma. - Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking. - Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.

NCT ID: NCT01949662 Active, not recruiting - Advanced Cancers Clinical Trials

Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

Start date: January 2014
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well haloperidol with or without lorazepam works in reducing confusion, disorientation, and inability to think or remember clearly (delirium) in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Palliative therapy with haloperidol and lorazepam may reduce symptoms of delirium and help patients with advanced cancer live more comfortably. It is not yet known whether lorazepam may be an effective treatment for delirium when given with haloperidol.

NCT ID: NCT01949545 Completed - Solid Tumors Clinical Trials

Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment

Start date: October 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with varying degrees of liver function to see if they respond differently to the study drug.

NCT ID: NCT01947140 Completed - Multiple Myeloma Clinical Trials

Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies

PDX+Romi
Start date: September 9, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate are in patients with lymphoid malignancies and to determine the dose of the combination of drugs that is safest. If the combination is determined to be safe, the study will continue accrual patients with peripheral T-Cell lymphoma (PTCL).

NCT ID: NCT01946672 Completed - Clinical trials for Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy

Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer

SENTIJAMBE
Start date: July 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the feasibility of an isotopic technique to identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we will determine the incidence of lymhedema.

NCT ID: NCT01946529 Active, not recruiting - Clinical trials for Desmoplastic Small Round Cell Tumor

Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors

Start date: December 27, 2013
Phase: Phase 2
Study type: Interventional

This protocol will study treatment for Ewing sarcoma family of tumors (ESFT) and desmoplastic small round cell tumor (DSRCT). Participants with ESFT will be divided into two treatment groups, A or B, based on tumor characteristics. Group A (standard risk) participants have tumor that is not in the pelvis, has not spread to other parts of the body, and are less than 14 years of age. Because previous clinical trials have shown that standard treatment is very effective for children whose tumors have these characteristics, these participants will receive standard treatment. Group B (high risk) participants are 14 years of age or older or have tumor in the pelvis, or the tumor has spread to other parts of the body. Participants with DSRCT in the abdomen and/or pelvis or with tumor that cannot be removed by surgery alone or has spread to other parts of the body will be included in Group B. Participants in this group are considered high risk because there is a greater chance of tumor recurring following standard treatments currently in use. All participants will be followed and evaluated for 10 years following completion of therapy.

NCT ID: NCT01946217 Completed - HIV Infection Clinical Trials

Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials

Start date: September 2013
Phase: N/A
Study type: Observational

This pilot research trial studies factors affecting patient participation in Acquired Immune Deficiency Syndrome (AIDS) Malignancy Clinical Trials Consortium clinical trials. Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.