Clinical Trials Logo

Filter by:
NCT ID: NCT00568308 Terminated - Cancer Clinical Trials

Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma

PATHWAY
Start date: December 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

NCT ID: NCT00567190 Completed - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

CLEOPATRA
Start date: February 12, 2008
Phase: Phase 3
Study type: Interventional

This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.

NCT ID: NCT00566579 Terminated - Clinical trials for Human Papillomavirus Clearance at 12 Months

Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions

Cryotherapy
Start date: December 2007
Phase: N/A
Study type: Interventional

Persistent human papillomavirus (HPV) infections is the single necessary cause of cervical cancer. Cervical cancer is still the major health problem in the developing countries. It has been the first rank women's cancer in Thailand for many decades. Approximately 10-20% of Thai women have the high-risk HPV (HR-HPV) infections in their cervices. This will frequently lead to low-grade squamous intraepithelial lesions (LSILs) (10%), high-grade squamous intraepithelial lesions (HSILs) (0.8%), and finally, cervical cancers (0.16%) within 10-20 years. The treatment options for LSILs are either observation or ablative surgery. However, in our institute, cryotherapy, which is the one of ablative surgery, is more frequently used to comfort our women. It is not only effective but safe with only minimal side effects; watery leukorrhea for 2-4 weeks, and local cervical infection not more than 1%. Contraindication to this procedure are active cervical infection, lesion of 2 mm-larger than probe, lesion inside cervical os and suspected cervical cancer. Additionally, in developing countries such as Thailand, this treatment is safe, acceptable, feasible and effective. Patients with LSILs could also have this treatment in some rural area from the 10-days trained nurses. Fortunately, recent reports showed that cryotherapy has abilities not only in clearing LSILs but also clearing the HPV infections, its necessary cause. However, there are no randomized controlled trial compared its clearing ability between observation and cryotherapy. Therefore, a randomized controlled trial is needed to demonstrate that. Findings from this trial will contribute enormously to older women who already get infected by HPV. Aside from preventing cervical cancer in treated woman, cryotherapy could also give her relief from worrying about having a time-bomb like HPV infection in her cervix.

NCT ID: NCT00565448 Completed - Carcinoma Clinical Trials

Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents

Start date: November 2007
Phase: Phase 2
Study type: Interventional

The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC). The secondary objectives are to determine: - the safety of TCF in comparison to CF after induction treatment of NPC, - the pharmacokinetics of docetaxel when added to CF, - the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.

NCT ID: NCT00564681 Completed - Cervical Dystonia Clinical Trials

Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia

Start date: December 2007
Phase: Phase 2
Study type: Interventional

Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.

NCT ID: NCT00561509 Completed - Clinical trials for Major Depressive Disorder

Multi-Country Observational Study to Collect the Frequency of Sexual Dysfunction With Antidepressant Treatment, Either With SSRIs or Duals at 8 Weeks and 6 Months

Start date: November 2007
Phase: N/A
Study type: Observational

In usual clinical conditions, depressed patients with no sexual dysfunction, after signing their consent for the dissemination of their clinical information will begin their treatment with any SSRI or a Dual antidepressant as per the best clinical decision of their treating psychiatrist. Sexual dysfunction will be identified along the 6 months of active observation. Psychiatrists will decide to change dose, augment, shift or combine antidepressants at their clinical discretion in the benefit of their patients and all clinical decisions will be recorded.Comparisons among antidepressants will be made in terms of their sexual dysfunction potentiality.

NCT ID: NCT00559273 Completed - Anemia Clinical Trials

A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis.

Start date: December 2007
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Patients will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kg, or darbepoetin alfa once weekly, at a starting dose of 0.45 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00558636 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

Start date: September 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study conducted in Asia-Pacific was to evaluate the efficacy and safety of Sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for chemonaive patients with unresectable stage IIIB (with effusion) or stage IV NSCLC. However, as indicated below, the study was terminated prematurely when the results from Study 11961 (NCT00300885), an earlier Phase 3 study of similar design in subjects with advanced NSCLC, showed an overall lack of efficacy and increased mortality in subjects with squamous subtype. The data available is presented as descriptive analyses, due to the limitations of implementing the statistical analysis plan.

NCT ID: NCT00558259 Completed - Clinical trials for Venous Thromboembolism

Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

RE-SONATE
Start date: November 2007
Phase: Phase 3
Study type: Interventional

The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).

NCT ID: NCT00558103 Completed - Neoplasms, Breast Clinical Trials

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

Start date: December 2007
Phase: Phase 2
Study type: Interventional

The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.