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NCT ID: NCT02540356 Terminated - Clinical trials for Refractory Ovarian Cancer With Recurrent Symptomatic Malignant Ascites

Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer

Start date: November 2, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after intravenous (IV) infusion (IV+IP) (Double-Route Arm), and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for each Arm separately, in subjects with refractory ovarian cancer and recurrent malignant ascites. In both Arms, the plasma pharmacokinetics (PK) of BAX69 will be characterized, and pharmacodynamics (PD) markers will be explored in plasma and ascites. Two expansion cohorts will further assess the tolerability of the RP2D and explore clinical signs of efficacy.

NCT ID: NCT02540330 Terminated - Clinical trials for Female Breast Carcinoma

A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant

007
Start date: March 2016
Phase: Phase 2
Study type: Interventional

This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.

NCT ID: NCT02540291 Terminated - Tumors Clinical Trials

Study of E7046 in Subjects With Selected Advanced Malignancies

Start date: July 30, 2015
Phase: Phase 1
Study type: Interventional

This is an open label, multicenter, Phase 1 study of E7046 to assess the safety and tolerability of E7046 and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of E7046.

NCT ID: NCT02540083 Terminated - Breast Cancer Clinical Trials

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

ADAPT-ENRICH
Start date: August 2015
Phase: N/A
Study type: Interventional

The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other performance measures.

NCT ID: NCT02539719 Terminated - Ovarian Cancer Clinical Trials

Study of SC-003 Alone and in Combination With ABBV-181 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer

Start date: August 2015
Phase: Phase 1
Study type: Interventional

This is a Phase 1a/1b study of SC-003 as a single agent and in combination with ABBV-181 in patients with platinum-resistant/refractory ovarian cancer. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy. ABBV-181 is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1 (PD-1).

NCT ID: NCT02539563 Terminated - Labor Clinical Trials

Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?

Start date: June 4, 2015
Phase: N/A
Study type: Interventional

Labor patients who meet inclusion and exclusion criteria will be consented to be participate in this study to determine if the use of a peanut shaped birthing ball reduces the length of labor and reduces the incidence of cesarean section. Subjects will be randomized at the time of consent to either use the birthing ball or not use the birthing ball from the time of labor analgesia until complete cervical dilation.

NCT ID: NCT02539459 Terminated - Clinical trials for Sporadic Angiomyolipomas (AMLs)

Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus

SAGE
Start date: September 23, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to see if oral everolimus is tolerable and effective in the treatment of sporadic Angiomyolipomas (AMLs). AMLs are the most common non-cancerous tumor of the kidney. They are composed of blood vessels, muscle cells and fat cells.Everolimus is already an approved drug for several other diseases like kidney cancer, but is being studied now specifically to see if it is helpful for people with AML.

NCT ID: NCT02539342 Terminated - Oral Mucositis Clinical Trials

Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy

Start date: October 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the administration of Caphosol rinse, at the start of chemotherapy, will prevent the development of mucositis (greater than or equal to grade 2 in children, adolescents and young adults. This is a randomized, controlled trial.

NCT ID: NCT02538627 Terminated - Colorectal Cancer Clinical Trials

Phase 1 Combination Study of MM-151 With MM-121, MM-141, or Trametinib

Start date: August 2015
Phase: Phase 1
Study type: Interventional

This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.

NCT ID: NCT02538614 Terminated - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia

Start date: December 29, 2015
Phase: Phase 1
Study type: Interventional

This study consists of 2 parts: Phase 1b and Phase 2. Phase 1b will evaluate the safety and tolerability of the combination of idelallisib with the anti-CD37 monoclonal antibody BI 836826 in participants with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), and establish the high recommended Phase 2 combination dose (highRP2D) as well as an alternate lower recommended Phase 2 combination dose (lowRP2D). Phase 2 will determine the rates of complete response (CR) and of minimal residual disease (MRD) negativity with the combination at the highRP2D and the lowRP2D in participants with R/R CLL.