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DOXIL/CAELYX Treatment Sequence AB

Phase 1

Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Nov 11, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment89
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02081495A Study of DOXIL/CAELYX in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian CancerPHASE1 COMPLETED 35 — — Aug 1, 2014Nov 1, 2015Nov 11, 20166 United States, Belgium +2
NCT01815294A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian CancerPHASE1 COMPLETED 54 — — May 1, 2013Dec 1, 2014Dec 4, 20158 United States, Belgium +2
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) of encapsulated doxorubicin
Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)

Cmax is defined as the maximum observed analyte concentration.

Time to reach the maximum observed plasma concentration (Tmax) of encapsulated doxorubicin
Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)

Tmax is defined as the actual sampling time to reach maximum observed analyte concentration.

Area under the plasma concentration-time curve from time 0 to infinite time (AUC[0-infinity]) of encapsulated doxorubicin
Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)

AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of the Area Under the Curve (AUC) last and AUC(last)/lambda, in which AUC(last) is the last observed quantifiable concentration.

Maximum observed plasma concentration of encapsulated doxorubicin in participants with ovarian cancer
Predose Day 1 Cycles 1-2; Postdose Cycles 1-2 at 15 min, 30 min, 60 min, 90 min, 95 min, 105 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 72 h, 96 h, 168 h, 336 h, 504 h, 672 h
Area under the plasma-concentration-versus time curve from time 0 to time t of encapsulated doxorubicin in participants with ovarian cancer
Predose Day 1 Cycles 1-2; Postdose Cycles 1-2 at 15 min, 30 min, 60 min, 90 min, 95 min, 105 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 72 h, 96 h, 168 h, 336 h, 504 h, 672 h
Area under the plasma-concentration-versus time curve from time 0 to infinite time of encapsulated doxorubicin in participants with ovarian cancer
Predose Day 1 Cycles 1-2; Postdose Cycles 1-2 at 15 min, 30 min, 60 min, 90 min, 95 min, 105 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 72 h, 96 h, 168 h, 336 h, 504 h, 672 h
Secondary Endpoints
Maximum observed plasma concentration (Cmax) of free doxorubicin
Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)
Time to reach the maximum observed plasma concentration (T max) of free doxorubicin
Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)
Area under the plasma concentration-time curve from time 0 to infinite time (AUC[0 - infinity]) of free doxorubicin
Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence ABEXPERIMENTALTwenty-one participants will receive DOXIL/CAELYX reference product in Cycle 1 and DOXIL/CAELYX test product in Cycle 2. Each cycle will be separated by 28 days.
Sequence BAEXPERIMENTALTwenty-one participants will receive DOXIL/CAELYX test product in Cycle 1 and DOXIL/CAELYX reference product in Cycle 2. Each cycle will be separated by 28 days.
Treatment A: DOXIL/CAELYX (doxorubicin)EXPERIMENTAL50 mg/m2 of doxorubicin manufactured at the current site of manufacturing administered by IV infusion over 90 minutes on Day 1
Treatment B: DOXIL/CAELYX (doxorubicin)EXPERIMENTAL50 mg/m2 of doxorubicin manufactured at the new site of manufacturing (test product) administered by IV infusion over 90 minutes on Day 1
Interventions
NameTypeDescription
DOXIL/CAELYX reference product (Treatment A)DRUGParticipants will receive DOXIL/CAELYX reference product 50 mg/m2 as an intravenous (into a vein) infusion over 90 minutes on Day 1.
DOXIL/CAELYX test product (Treatment B)DRUGParticipants will receive DOXIL/CAELYX test product 50 mg/m2 as an intravenous infusion over 90 minutes on Day 1.
DOXIL/CAELYX (doxorubicin) Treatment Sequence ABDRUGCycle 1 = Treatment A, Cycle 2 = Treatment B
DOXIL/CAELYX (doxorubicin) Treatment Sequence BADRUGCycle 1 = Treatment B, Cycle 2 = Treatment A
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Having advanced or refractory solid malignancies (histologically or cytologically confirmed advanced ovarian cancer failing platinum-based chemotherapy or metastatic breast cancer after failing approved life prolonging therapies or any solid malignancy that is metastatic or un...

Countries:United StatesBelgiumCanadaSpainUnited Kingdom
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Competitive Landscape -Myeloproliferative Neoplasms 53 trials
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Bristol-Myers Squibb CompanyBMY5PHASE3ACE-536, Luspatercept, Fedratinib, BMS-986158, Ruxolitinib
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Karyopharm Therapeutics, Inc.KPTI4PHASE3Selinexor, Ruxolitinib, Pacritinib, Momelotinib
Geron CorporationGERN2PHASE3Imetelstat, Ruxolitinib
Incyte CorporationINCY11PHASE2itacitinib, Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C
Merck & Co., Inc.MRK1PHASE3Bomedemstat
GSK plc Sponsored ADRGSK2PHASE2MMB, Momelotinib, Luspatercept
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Elritercept, Ruxolitinib
Eli Lilly and CompanyLLY1PHASE1LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.IRON1PHASE1DISC-0974
Galecto, Inc.GLTO1PHASE2GB2064
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
United Therapeutics CorporationUTHR1PHASE2bomedemstat
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