Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 December 2019 |
Main ID: |
EUCTR2014-003604-75-FR |
Date of registration:
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14/08/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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An interventional study of oral HDM201 in combination with oral LEE011 in adult patients with liposarcoma
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Scientific title:
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A Phase Ib/II, open-label, multicenter study of oral HDM201 in combination with oral LEE011 in adult patients with liposarcoma |
Date of first enrolment:
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16/02/2015 |
Target sample size:
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59 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003604-75 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Canada
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France
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Germany
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Singapore
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Spain
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Taiwan
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United States
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Contacts
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Name:
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Information Communication Médicale
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Address:
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2-4 rue Lionel Terray
92500
Rueil-Malmaison
France |
Telephone:
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+3315547 6600 |
Email:
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icm.phfr@novartis.com |
Affiliation:
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Novartis Phrama S.A.S. |
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Name:
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Information Communication Médicale
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Address:
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2-4 rue Lionel Terray
92500
Rueil-Malmaison
France |
Telephone:
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+3315547 6600 |
Email:
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icm.phfr@novartis.com |
Affiliation:
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Novartis Phrama S.A.S. |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Male or Female age 18 years or older.
• Patients with histologically documented, locally advanced or metastatic WD/DD liposarcoma that has progressed on/or despite one prior systemic therapy.
• Patients with radiographic progression, defined by RECIST v.1.1, occurring while on/or within 6 months after last systemic treatment, prior to enrollment.
• Patients must have disease that can be evaluated by RECIST v1.1; measurable disease is required for patients enrolled in the Phase II.
• ECOG performance status of 0-1.
• Patients suitable and willing to undergo baseline biopsy.
Other protocol-defined inclusion criteria may apply 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29
Exclusion criteria: • Prior treatment with compounds with the same mode of action.
• Patients with TP53 mutated tumors, if the molecular status is known.
• Symptomatic central nervous system metastases.
• Impaired cardiac function.
• Inadequate organ function.
• Concomitant treatment with: Restriction in the use of moderate to strong inhibitors or inducers of CYP3A4/5, substrates of CYP3A4/5 with a narrow therapeutic index or medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes.
• Concomitant treatment with colony-stimulating growth factors targeting the myeloid lineage (e.g. G-CSF, GM-CSF, M-CSF).
Other protocol-defined exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Liposarcoma
MedDRA version: 18.0
Level: LLT
Classification code 10049280
Term: Solid tumour
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Code: HDM201 Pharmaceutical Form: Capsule, hard INN or Proposed INN: not yet available Current Sponsor code: HDM201 Other descriptive name: HDM201 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5-
Product Code: HDM201 Pharmaceutical Form: Capsule, hard INN or Proposed INN: not yet available Current Sponsor code: HDM201 Other descriptive name: HDM201 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
Product Code: HDM201 Pharmaceutical Form: Capsule, hard INN or Proposed INN: not yet available Current Sponsor code: HDM201 Other descriptive name: HDM201 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Product Code: HDM201 Pharmaceutical Form: Capsule, hard INN or Proposed INN: not yet available Current Sponsor code: HDM201 Other descriptive name: HDM201 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1-
Product Code: LEE011 Pharmaceutical Form: Capsule INN or Proposed INN: not yet available Current Sponsor code: LEE011 Other descriptive name: LEE011 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Product Code: LEE011 Pharmaceutical Form: Capsule INN or Proposed INN: not yet available
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Phase1b: 1. First cycle of treatment (28 days for Regimen 1 and 3 / 35 days for Regimen 2) 2. For all regimens: on D1, 2, 8, 14, 15 for Cycle1 Phase 2: PFS at 12 and 24 weeks
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Main Objective: Phase Ib: To determine the MTD and/or RP2D of HDM201 in combination with LEE011 in patients with liposarcoma. Phase2: To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in patients with liposarcoma.
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Primary end point(s): Phase1b: 1. Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment 2. Exposure to HDM201 and LEE011 as measured by AUC0-24h at C1D14 Phase 2: PFS as per RECIST 1.1, assessed by investigator
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Secondary Objective: Phase1b/2: 1. To characterize the safety and tolerability of HDM201 in combination with LEE011 2. To characterize the pharmacokinetic (PK) properties of HDM201 in combination with LEE011 and potential metabolite/s when feasible 3. To assess the pharmacodynamic (PD) effect of HDM201 in combination with LEE011 and a potential relationship with clinical outcome Phase Ib: To assess preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma Phase II To further assess the anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma
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Secondary Outcome(s)
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Secondary end point(s): Phase 1b/2:
1. Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, ECG
Tolerability: Dose interruptions, reductions and dose intensity.
2. Time vs. plasma concentration profiles, PK parameters of HDM201 and LEE011 and potential metabolite/s when feasible
3. Anti-tumor activity endpoint (BOR, PFS) and changes from baseline of PD markers:
- In tumor tissue (e.g. p21, PUMA, MDM2)
- In blood (e.g. GDF-15)
Phase1b:
BOR, ORR and PFS as per RECIST v1.1, assessed by investigator
Phase 2:
- BOR, ORR and DOR as per RECIST v 1.1 assessed by investigator
- OS
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Timepoint(s) of evaluation of this end point: Phase 1b/2:
1. Every cycle
2. For all regimens: on D1, 2, 8, 14, 15 for Cycle1 - on D1, 8, 14 for Cycle 2 and on D14 for Cycle 3 and 4
3. Baseline, up to 14 days
Phase1b:
BOR, ORR and PFS at 6 months
Phase 2:
- BOR, ORR and DOR at 6 months
- OS at 12 months
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Secondary ID(s)
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CHDM201X2103C
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2014-003604-75-ES
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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