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出境医 / 临床实验 / Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors

Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors

Study Description
Brief Summary:
The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of Debio 0123 in combination with carboplatin in participants with advanced solid tumors that recurred or progressed following prior platinum based therapy and for which no standard therapy of proven benefit is available.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Debio 0123 Drug: Carboplatin Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Oral Debio 0123 in Combination With Carboplatin in Patients With Advanced Solid Tumors
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : May 1, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Debio 0123
Participants will receive Debio 0123 as monotherapy (Day -3), orally, in the morning and once daily for 3 days during Cycle 1 then in combination with carboplatin intravenous infusion from Cycle 2 onwards.
 Drug: Debio 0123
Debio 0123 will be given as an oral capsule, once daily for 3 days during each 21-day cycle.

Drug: Carboplatin
Carboplatin will be given as an intravenous infusion in combination with Debio 0123 on Day 1 from Cycle 2 onwards.
Outcome Measures
Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) of Debio 0123 When Administered in Combination with Carboplatin [ Time Frame: 2 Cycles i.e., 42 days (1 cycle = 21 days) ]

Secondary Outcome Measures :
  1. Percentage of Participants with Dose Limiting Toxicities (DLTs) of Debio 0123 When Administered in Combination with Carboplatin [ Time Frame: 2 Cycles i.e., 42 days (1 cycle = 21 days) ]
  2. Percentage of Participants with Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: Up to 46 months ]
  3. Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Laboratory Abnormalities [ Time Frame: Up to 46 months ]
  4. Percentage of Participants with Treatment Discontinuations and Treatment Modifications Due to Adverse Events (AEs) and Laboratory Abnormalities [ Time Frame: Up to 46 months ]
  5. Number of Participants with Changes in Vital Signs [ Time Frame: Screening, Day 1 of each 21-day Cycle up to 46 months ]
  6. Number of Participants with Changes in Electrocardiogram (ECG) [ Time Frame: Screening; Pre-dose, 2, 4 hours post-dose Days -3 and 3 Cycle 1 (each cycle is 21 days); Days 1 and 3 Cycle 2; pre-dose and post-dose; Day 1 Cycle 3, 4, 5, and at End of Treatment (Up to 46 months) ]
  7. Number of Participants with Change in Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Screening, Day 1 of 21 days Cycle (Up to 46 months) ]
  8. Maximum Plasma Concentration (Cmax) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  9. Time to Maximum Concentration (Tmax) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  10. Area Under the Concentration Curve Over the Time 0 to Time of the Last Quantifiable Concentration [AUC(0-t)] of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  11. Area Under the Plasma Concentration-Time Curve Over the Dosing Interval of T (AUCτ) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  12. Area Under the Concentration Curve Over the Time 0 to Infinity (AUC∞) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  13. Apparent Elimination Rate Constant During the Terminal Phase (λz) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  14. Apparent Terminal Half-Life (t½) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  15. Mean Residence Time (MRT) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  16. Apparent Total Body Clearance (Oral Clearance) (CL/F) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  17. Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  18. Peak-to-Trough Fluctuation (PTF) of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  19. Accumulation Ratio on AUC [R(AUC)] of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  20. Accumulation ratio on Cmax [R(Cmax)] of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  21. Linearity Index (LI) of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  22. Average Steady-State Concentration [C(av,ss)] of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  23. Trough Concentrations (Ctrough) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  24. Cumulative Amount Excreted in Urine (Ae) of Debio 0123 [ Time Frame: Day 1 up to Day 4 Cycle 1 (each cycle is 21 days) ]
  25. Percentage of the Dose Administered Excreted in Urine (Ae%) of Debio 0123 [ Time Frame: Day 1 up to Day 4 Cycle 1 (each cycle is 21 days) ]
  26. Renal Clearance (CLR) of Debio 0123 [ Time Frame: Day 1 up to Day 4 Cycle 1 (each cycle is 21 days) ]
  27. AUC∞ of Free Platinum in Plasma Ultrafiltrate of Carboplatin in Combination [ Time Frame: Day 1 Cycle 2 (each cycle is 21 days) ]
  28. Correlation Between Plasma Concentration of Debio 0123 (and its Metabolite) and Changes in QT Interval Corrected Using Fridericia's Formula (QTcF) [ Time Frame: Up to 46 months ]
  29. Tumor Response [ Time Frame: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months) ]
  30. Progression Free-Survival (PFS) [ Time Frame: From the start of study treatment until disease progression or death from any cause, whichever occurs first (Up to 46 months) ]
  31. Overall Survival (OS) [ Time Frame: From the start of study treatment until disease progression or death from any cause, whichever occurs first (Up to 46 months) ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced or metastatic solid and nonbleeding tumors that had recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy of proven benefit is available
  • Able and willing to undergo tumor biopsy
  • Prior platinum-based therapy (carboplatin or cisplatin).
  • Life expectancy of at least 3 months
  • ECOG performance score 0-1

Exclusion Criteria:

  • History of other malignancies requiring active treatment in the last 6 months
  • Brain tumors and/or symptomatic brain metastases
  • Receiving other investigating agents
  • Presence of significant cardiovascular disease or other co-morbidities such as symptomatic ascites
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Debiopharm International S.A +41 21 321 01 11 clinicaltrials@debiopharm.com

Locations
Layout table for location information
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713
Leiden University Medical Center, Dept. of Clinical Oncology Recruiting
Leiden, Netherlands, 2333
Radboud university medical center Recruiting
Nijmegen, Netherlands, 6525
Spain
Hospital Vall Hebrón, Unidad de Investigación en Terapia Molecular (UITM) Recruiting
Barcelona, Spain, 08035
Sponsors and Collaborators
Debiopharm International SA
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE July 30, 2019
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		Recommended Phase 2 Dose (RP2D) of Debio 0123 When Administered in Combination with Carboplatin [ Time Frame: 2 Cycles i.e., 42 days (1 cycle = 21 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2021)
  • Percentage of Participants with Dose Limiting Toxicities (DLTs) of Debio 0123 When Administered in Combination with Carboplatin [ Time Frame: 2 Cycles i.e., 42 days (1 cycle = 21 days) ]
  • Percentage of Participants with Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: Up to 46 months ]
  • Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Laboratory Abnormalities [ Time Frame: Up to 46 months ]
  • Percentage of Participants with Treatment Discontinuations and Treatment Modifications Due to Adverse Events (AEs) and Laboratory Abnormalities [ Time Frame: Up to 46 months ]
  • Number of Participants with Changes in Vital Signs [ Time Frame: Screening, Day 1 of each 21-day Cycle up to 46 months ]
  • Number of Participants with Changes in Electrocardiogram (ECG) [ Time Frame: Screening; Pre-dose, 2, 4 hours post-dose Days -3 and 3 Cycle 1 (each cycle is 21 days); Days 1 and 3 Cycle 2; pre-dose and post-dose; Day 1 Cycle 3, 4, 5, and at End of Treatment (Up to 46 months) ]
  • Number of Participants with Change in Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Screening, Day 1 of 21 days Cycle (Up to 46 months) ]
  • Maximum Plasma Concentration (Cmax) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Time to Maximum Concentration (Tmax) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Area Under the Concentration Curve Over the Time 0 to Time of the Last Quantifiable Concentration [AUC(0-t)] of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Area Under the Plasma Concentration-Time Curve Over the Dosing Interval of T (AUCτ) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Area Under the Concentration Curve Over the Time 0 to Infinity (AUC∞) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Apparent Elimination Rate Constant During the Terminal Phase (λz) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Apparent Terminal Half-Life (t½) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Mean Residence Time (MRT) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Apparent Total Body Clearance (Oral Clearance) (CL/F) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Peak-to-Trough Fluctuation (PTF) of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Accumulation Ratio on AUC [R(AUC)] of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Accumulation ratio on Cmax [R(Cmax)] of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Linearity Index (LI) of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Average Steady-State Concentration [C(av,ss)] of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Trough Concentrations (Ctrough) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Cumulative Amount Excreted in Urine (Ae) of Debio 0123 [ Time Frame: Day 1 up to Day 4 Cycle 1 (each cycle is 21 days) ]
  • Percentage of the Dose Administered Excreted in Urine (Ae%) of Debio 0123 [ Time Frame: Day 1 up to Day 4 Cycle 1 (each cycle is 21 days) ]
  • Renal Clearance (CLR) of Debio 0123 [ Time Frame: Day 1 up to Day 4 Cycle 1 (each cycle is 21 days) ]
  • AUC∞ of Free Platinum in Plasma Ultrafiltrate of Carboplatin in Combination [ Time Frame: Day 1 Cycle 2 (each cycle is 21 days) ]
  • Correlation Between Plasma Concentration of Debio 0123 (and its Metabolite) and Changes in QT Interval Corrected Using Fridericia's Formula (QTcF) [ Time Frame: Up to 46 months ]
  • Tumor Response [ Time Frame: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months) ]
  • Progression Free-Survival (PFS) [ Time Frame: From the start of study treatment until disease progression or death from any cause, whichever occurs first (Up to 46 months) ]
  • Overall Survival (OS) [ Time Frame: From the start of study treatment until disease progression or death from any cause, whichever occurs first (Up to 46 months) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Percentage of Participants with Dose Limiting Toxicities (DLTs) of Debio 0123 When Administered in Combination with Carboplatin [ Time Frame: 2 Cycles i.e., 42 days (1 cycle = 21 days) ]
  • Percentage of Participants with Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: Up to 46 months ]
  • Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Laboratory Abnormalities [ Time Frame: Up to 46 months ]
  • Percentage of Participants with Treatment Discontinuations and Treatment Modifications Due to Adverse Events (AEs) and Laboratory Abnormalities [ Time Frame: Up to 46 months ]
  • Number of Participants with Changes in Vital Signs [ Time Frame: Screening, Day 1 of 21 days Cycle (Up to 46 months) ]
  • Number of Participants with Changes in Electrocardiogram (ECG) [ Time Frame: Screening, Pre-dose, 2, 4 hours post-dose Day -3, 3 Cycle 1(each cycle is 21 days), Day 1, 3 Cycle 2; pre-dose and post-dose Day 1 Cycle 3, 4, 5, End of Treatment (Up to 46 months) ]
  • Number of Participants with Change in Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Screening, Day 1 of 21 days Cycle (Up to 46 months) ]
  • Maximum Plasma Concentration (Cmax) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Time to Maximum Concentration (Tmax) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Area Under the Concentration Curve Over the Time 0 to Time of the Last Quantifiable Concentration [AUC(0-t)] of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Area Under the Plasma Concentration-Time Curve Over the Dosing Interval of T (AUCτ) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Area Under the Concentration Curve Over the Time 0 to Infinity (AUC∞) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Apparent Elimination Rate Constant During the Terminal Phase (λz) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Apparent Terminal Half-Life (t½) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Mean Residence Time (MRT) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Apparent Total Body Clearance (Oral Clearance) (CL/F) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Debio 0123 [ Time Frame: Days -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (Up to 46 months) ]
  • Peak-to-Trough Fluctuation (PTF) of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Accumulation Ratio on AUC [R(AUC)] of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Accumulation ratio on Cmax [R(Cmax)] of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Linearity Index (LI) of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Average Steady-State Concentration [C(av,ss)] of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1 (each cycle is 21 days) ]
  • Trough Concentrations (Ctrough) of Debio 0123 [ Time Frame: Day -3, -2, -1, 1, 3 in Cycle 1(each cycle is 21 days); Day 1, 2, 3 Cycle 2, 3 and subsequent cycles until end of treatment (up to 46 months)] ]
  • Cumulative Amount Excreted in Urine (Ae) of Debio 0123 [ Time Frame: Day 1 up to Day 4 Cycle 1 (each cycle is 21 days) ]
  • Percentage of the Dose Administered Excreted in Urine (Ae%) of Debio 0123 [ Time Frame: Day 1 up to Day 4 Cycle 1 (each cycle is 21 days) ]
  • Renal Clearance (CLR) of Debio 0123 [ Time Frame: Day 1 up to Day 4 Cycle 1 (each cycle is 21 days) ]
  • AUC∞ of Free Platinum in Plasma Ultrafiltrate of Carboplatin in Combination [ Time Frame: Day 1 Cycle 2 (each cycle is 21 days) ]
  • Correlation Between Plasma Concentration of Debio 0123 (and its Metabolite) and Changes in QT Interval Corrected Using Fridericia's Formula (QTcF) [ Time Frame: Up to 46 months ]
  • Tumor Response [ Time Frame: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months) ]
  • Progression Free-Survival (PFS) [ Time Frame: From the start of study treatment until disease progression or death from any cause, whichever occurs first (Up to 46 months) ]
  • Overall Survival (OS) [ Time Frame: From the start of study treatment until disease progression or death from any cause, whichever occurs first (Up to 46 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study of Oral Debio 0123 in Combination With Carboplatin in Patients With Advanced Solid Tumors
Brief Summary The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of Debio 0123 in combination with carboplatin in participants with advanced solid tumors that recurred or progressed following prior platinum based therapy and for which no standard therapy of proven benefit is available.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • Drug: Debio 0123
    Debio 0123 will be given as an oral capsule, once daily for 3 days during each 21-day cycle.
  • Drug: Carboplatin
    Carboplatin will be given as an intravenous infusion in combination with Debio 0123 on Day 1 from Cycle 2 onwards.
Study Arms  ICMJE Experimental: Debio 0123
Participants will receive Debio 0123 as monotherapy (Day -3), orally, in the morning and once daily for 3 days during Cycle 1 then in combination with carboplatin intravenous infusion from Cycle 2 onwards.
Interventions:
  • Drug: Debio 0123
  • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2021) 		40
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		24
Estimated Study Completion Date  ICMJE May 1, 2023
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced or metastatic solid and nonbleeding tumors that had recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy of proven benefit is available
  • Able and willing to undergo tumor biopsy
  • Prior platinum-based therapy (carboplatin or cisplatin).
  • Life expectancy of at least 3 months
  • ECOG performance score 0-1

Exclusion Criteria:

  • History of other malignancies requiring active treatment in the last 6 months
  • Brain tumors and/or symptomatic brain metastases
  • Receiving other investigating agents
  • Presence of significant cardiovascular disease or other co-morbidities such as symptomatic ascites
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Debiopharm International S.A +41 21 321 01 11 clinicaltrials@debiopharm.com
Listed Location Countries  ICMJE Netherlands,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03968653
Other Study ID Numbers  ICMJE Debio 0123-101
2018-003659-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Debiopharm International SA
Study Sponsor  ICMJE Debiopharm International SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Debiopharm International SA
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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