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mTOR inhibitor

Arm 2: Weekly paclitaxel plus TAK228 for Ovarian Cancer (DICE Trial)

Phase 2
Waitlist Available
Led By Jonathan Krell
Research Sponsored by Imperial College London
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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).

Eligible Conditions
  • Ovarian Cancer
  • Ovarian Adenocarcinoma
  • Ovarian Carcinoma
  • Ovarian Carcinosarcoma
  • Ovarian Tumors
  • Peritoneal Carcinoma
  • Peritoneal Serous Adenocarcinoma
  • Fallopian Tube Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Change from baseline QOL as assessed by EORTC QLQ-OV28 questionnaire
Change from baseline quality of life (QOL) as assessed by EORTC QLQ-C30 questionnaire Global Health Status Domain
Clinical Benefit Rate (CBR) at 4 months
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Weekly paclitaxel plus TAK228Experimental Treatment2 Interventions
Paclitaxel, concentrate for solution for infusion 80mg per metre squared on day 1, 8 and 15 of a 28 day cycle. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria TAK228, oral capsule 4mg on days 2-4, 9-11, 16-18 and 23-25 of a 28 day cycle i.e. in concurrence with paclitaxel. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria
Group II: Arm 1: Weekly paclitaxel aloneActive Control1 Intervention
Paclitaxel, concentrate for solution for infusion 80mg per metre squared on day 1, 8 and 15 of a 28 day cycle. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5810
TAK228
2018
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

North Eastern German Society of Gynaecological OncologyOTHER
24 Previous Clinical Trials
8,971 Total Patients Enrolled
14 Trials studying Ovarian Cancer
2,880 Patients Enrolled for Ovarian Cancer
Imperial College LondonLead Sponsor
1,031 Previous Clinical Trials
15,024,452 Total Patients Enrolled
4 Trials studying Ovarian Cancer
1,644 Patients Enrolled for Ovarian Cancer
Takeda Pharmaceuticals International, Inc.Industry Sponsor
7 Previous Clinical Trials
841 Total Patients Enrolled
~19 spots leftby Oct 2025
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