Use of Ketotifen to enhance treatment efficacy in patients with sarcoma

Phase II trial for the use of ketotifen to enhance therapy in patients with sarcoma receiving standard chemotherapy - DL-MechanoPredictor

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002311-39-CY

Enrollment

Registered

2022-09-09

Start date

2022-09-07

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Patients with sarcoma

Interventions

Trade Name: Zaditen Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria include: • patients aged 18 and over, • with a biopsy proven sarcoma subtype, • a performance status (PS) 0 or 1 (ECOG), with • adequate hematologic, renal, hepatic and cardiac function as per internationally accepted standards. 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Exclusion criteria: • operable sarcoma, • PS 2 or above, • prior systemic treatment with doxorubicin for sarcoma or treatment with ketotifen in the past for other indications. • Hypersensitivity to the active substance or to any of the excipients (Magnesium stearate, Maize starch, Pregelatinised maize starch, Lactose monohydrate) • Epilepsy • Patients being treated with oral antidiabetic agent(s) • During Pregnancy and Breastfeeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: This trial’s objective is to demonstrate that the use of ketotifen can improve the efficacy of chemotherapy in patients with sarcoma. ;Secondary Objective: A secondary objective of this trial is to demonstrate that measuring and monitoring tumor stiffness using non-invasive, clinically applied ultrasound shear wave elastography can be used as a predictive biomarker.;Primary end point(s): Primary endpoint: confirm that TME reprogramming (change in mechanical properties of tumor) can be objectively assessed on ultrasound measurements of elastography after at least 3 cycles of combination treatment. This marker will represent a mechanical biomarker of response to treatment. ;Timepoint(s) of evaluation of this end point: All patients will be subjected to ultrasound imaging after completing 3 cycles of doxorubicin or combination (doxorubicin + ketotifen) treatment and a final measurement will be taken by the completion of 6 cycles.	—

Measure

Time frame

Main Objective: This trial’s objective is to demonstrate that the use of ketotifen can improve the efficacy of chemotherapy in patients with sarcoma. ;Secondary Objective: A secondary objective of this trial is to demonstrate that measuring and monitoring tumor stiffness using non-invasive, clinically applied ultrasound shear wave elastography can be used as a predictive biomarker.;Primary end point(s): Primary endpoint: confirm that TME reprogramming (change in mechanical properties of tumor) can be objectively assessed on ultrasound measurements of elastography after at least 3 cycles of combination treatment. This marker will represent a mechanical biomarker of response to treatment. ;Timepoint(s) of evaluation of this end point: All patients will be subjected to ultrasound imaging after completing 3 cycles of doxorubicin or combination (doxorubicin + ketotifen) treatment and a final measurement will be taken by the completion of 6 cycles.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: (i) objective response rate (ORR) (which accounts for complete and partial responses) per RECIST 1.1, progression-free and OS and comparison with historical controls. (ii) document potential toxicity from the combination of ketotifen with standard of care systemic treatments. ;Timepoint(s) of evaluation of this end point: A final analysis is planned after completion of treatment schedule.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: (i) objective response rate (ORR) (which accounts for complete and partial responses) per RECIST 1.1, progression-free and OS and comparison with historical controls. (ii) document potential toxicity from the combination of ketotifen with standard of care systemic treatments. ;Timepoint(s) of evaluation of this end point: A final analysis is planned after completion of treatment schedule.

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Countries

Cyprus

Contacts

Public ContactMME Department (Dr. Stylianopoulos)

University of Cyprus

markou.maria@ucy.ac.cy35722892248

Outcome results

None listed

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