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Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens

The primary purpose of the study is to determine the efficacy of AZD2281 compared to placebo in serous ovariancancer platinum sensitive patients and in a defined HRD subset.

RCT to investigate the quality of the of endometrial sample obtained by aspiration when performed before or after the SIS in postmenopausal women.

The primary objective is to investigate the quality (whether assessable by a pathologist or not) of the endometrial sample obtained by aspiration when performed directly before or after the SIS in postmenopausal women. Secondary objectives are to…

ENGOT-ov11/MILO study (MEK Inhibitor in Low-grade Serous Ovarian Cancer):
A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician*s Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum

Primary: • Demonstrate superior efficacy (increased progression-free survival [PFS]) of MEK162 vs. physician*s choice of selected chemotherapies (liposomal doxorubicin, paclitaxel and topotecan)Key Secondary: • Demonstrate superior efficacy (…

PORTEC-4: Randomised Phase III Trial Comparing Vaginal Brachytherapy (two doses schedules: 21 or 15 Gy HDR in 3 fractions) and Observation after Surgery in patients with Endometrial Carcinoma with High-Intermediate Risk Features

The primary objective of this study is to establish and compare the rates of vaginal relapse in patients with high-intermediate risk endometrial carcinoma treated with vaginal brachytherapy (standard versus reduced brachytherapy dose schedule of 21…

Phase III international, randomized study of Trabectedin plus Pegylated Liposomal Doxorubin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum.

The key objective of the study is to prove that trabectedin (Yondelis) and PLD prolong overall survival versus carboplatin + PLD, in patients with progressive ovarian cancer 6 to 12 months after completing previous platinum based chemotherapy.As…

A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old men.

This study is designed to evaluate the immunogenicity and tolerability of V503 in young men, 16 to 26 years of age, in comparison to GARDASIL® in young men, 16 to 26 years of age. The safety and immunogenicity data will be used to bridge GARDASIL®…

Phase Ib/II study of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer

The primary objective of the phase I part of the study is to determine the recommended phase II dose of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer. The secondary objectives the phase I…

A Phase III Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy

To determine the efficacy of olaparib versus placebo on progression free survival (PFS).

A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer

There is still no level I-II evidence for cytoreductive surgery in recurrent ovarian cancer. This is also the conclusion of a Cochrane Review of Galaal et al. published in June 2010. The most active chemotherapy in platinum sensitive recurrent…

A RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL COMPARING IPILIMUMAB VS. PLACEBO FOLLOWING RADIOTHERAPY IN SUBJECTS WITH CASTRATION RESISTANT PROSTATE CANCER THAT HAVE RECEIVED PRIOR TREATMENT WITH DOCETAXEL

The objective of this study is to compare the overall survival of patients with castration resistant prostate cancer who have progressed after receiving docetaxel treatment, when they are treated with bone directed radiotherapy plus Ipilimumab…

A randomized phase II trial of docetaxel plus carboplatin versus docetaxel in hormone refractory prostate cancer patients who have progressed after response to prior docetaxel chemotherapy: RECARDO STUDY

Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

* To demonstrate efficacy of the candidate vaccine in the prevention of (1) persistent infection (6-month definition) with HPV-16 or HPV-18 (by polymerase chain reaction [PCR]) and/or (2) histopathologically-confirmed CIN1+ associated with HPV-16 or…

A two-part, randomized Phase II, double-blind, multicenter trial assessing the efficacy and safety of pertuzumab in combination with standard chemotherapy vs. placebo plus standard chemotherapy in women with recurrent platinum resistant epithelial ovarian cancer and low HER3 mRNA expression

PRIMARY OBJECTIVEPart 1: Safety Run-in PhaseThe primary objective for Part 1 of this study is to determine the safety and tolerability of pertuzumab in combination with either topotecan or paclitaxel.Part 2The primary objective for Part 2 of this…

Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination
with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer

The objective of the study (phase 2) is to evaluate the effectiveness of AMG 102 in combination with Mitoxantrone and Prednisone in previously treated subjects with castrate resistant prostate cancer.

A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer

To show superiority of patupilone in overall survival compared to pegylated liposomal doxorubicin (Doxil®/Caelyx®) in taxane/platinum refractory/resistant patients with recurrentovariancancer.

Multicenter, randomised, double-blind Phase III trial to investigate the efficacy and safety of BIBF 1120 in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in patients with advanced ovarian cancer

zie study protocol

A randomized controlled trial to evaluate the effect on pelvic floor function of pelvic physiotherapy following radical hysterectomy in early stage cervical cancer.

To find out whether pelvic physiotherapy added to an information folder describing pelvic exercises, as is the standard post-operative policy, gives an improved pelvic related quality of life compared to patients receiving the folder only.

A phase III Trial of postoperative chemotherapy or no further treatment for patients with node-negative stage I-II intermediate or high risk endometrial cancer.

To demonstrate efficacy of adjuvant combination chemotherapy in a randomized phase III trial comparing to no further treatment in the medium and high-risk node negative stage I and stage II patients.

VAginal NOTES versus Laparoscopic hysterectomy in Uterine Endometrioid Cancer (VALUE-study): a multicentre randomized trial.

To evaluate the duration of admission, feasibility, patient satisfaction and complication rate of vNOTES hysterectomy with BSO and compare it with laparoscopic hysterectomy with BSO in case of clinical stage 1 low grade endometrial cancer.

A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium

The objectives are to assess the efficacy, safety and effect on quality of life of Nintedanib compared to chemotherapy in women with relapsed, advanced or metastatic clear cell cancer of the ovary of endometrium.