CompletedPhase 2

Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)

Germany, United Kingdom134 participantsStarted 2018-09-21

Plain-language summary

DICE is a randomised study recruiting 126 women over 3 years from hospitals in the UK and Germany. Eligible patients will have tissue based diagnosis of advanced/recurrent ovarian cancer (clear cell, endometrioid or high grade serous or carcinosarcoma), have had chemotherapy before, and be platinum-resistant (the cancer has returned/grown significantly during or within 6 months of platinum-containing chemotherapy).

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. Ischemic myocardial event, including angina requiring therapy and artery revascularisation procedures
✕. Ischemic cerebrovascular event, including transient ischemic attack and artery revascularisation procedures
✕. Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)
✕. Placement of a pacemaker for control of rhythm
✕. New York Heart Association (NYHA) Class III or IV heart failure
✕. Pulmonary embolism
✕. Uncontrolled hypertension (i.e., systolic blood pressure \> 180 mm Hg, diastolic blood pressure \> 95 mm Hg). Use of anti-hypertensive agents to control hypertension before first dose of study treatment is allowed.
✕. Pulmonary hypertension

What they're measuring

Progression Free Survival (PFS)

Timeframe: 12 months

Trial details

NCT IDNCT03648489

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-30

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