Immune regulation and timing of chemotherapy in advanced/recurrent ovarian and endometrial cancer - TIREG

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023457-11-BE

Enrollment

Registered

2011-01-24

Start date

2011-02-15

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced/recurrent ovarian and endometrial cancer MedDRA version: 12.1 Level: LLT Classification code 10057529 Term: Ovarian cancer metastatic MedDRA version: 12.1 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrent MedDRA version: 12.1 Level: PT Classification code 10057529 Term: Ovarian cancer metastatic MedDRA version: 12.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent MedDRA version: 12.1 Level: LLT Classification code 10014734 Term: Endometria

Interventions

Trade Name: Endoxan Product Name: Cyclophosphamide Pharmaceutical Form: Coated tablet INN or Proposed INN: CYCLOPHOSPHAMIDE CAS Number: 50180 Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Failure of two lines of cytotoxic chemotherapy (ovarian cancer) or one line of cytotoxic chemotherapy (endometrial cancer) - ECOG Status 1-2 - No previous chemotherapy for 3 months - Confirmed histological evidence of either ovarian or primary peritoneal malignancy or endometrial cancer. All histological types will be included. - Assessable disease by imaging (either CT Scan or MRI scan) will need to be present or alternatively, if absent, CA 125 levels should be at least twice normal and shown to have been increased on two occasions at least one week apart. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Documented autoimmune disease - Currently ongoing systemic corticosteroid therapy and/or immune suppressant therapy - Venous access is predicted to obviate frequent blood samples

Design outcomes

Primary

Measure	Time frame
Main Objective: Immunomodulation by synchronizing the administration of cytotoxic agents to the phase of the repeating anti-tumour immune cycle;Secondary Objective: Is the repeating anti-tumour immune cycle correlated with the level of regulatory T cells or inflammatory mediators and can these be affected by timing the administration of cytotoxic agents to certain phases of the anti-tumour immune cycle?;Primary end point(s): Response rate according to GCIG criteria for CA125 response and RECIST criteria for imaging response	—

Measure

Time frame

Main Objective: Immunomodulation by synchronizing the administration of cytotoxic agents to the phase of the repeating anti-tumour immune cycle;Secondary Objective: Is the repeating anti-tumour immune cycle correlated with the level of regulatory T cells or inflammatory mediators and can these be affected by timing the administration of cytotoxic agents to certain phases of the anti-tumour immune cycle?;Primary end point(s): Response rate according to GCIG criteria for CA125 response and RECIST criteria for imaging response

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026