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DOXIL/CAELYX

Phase 1

Ovarian Cancer | Small molecule | Oncology |Baxter International Inc.|Trials Updated: Jun 5, 2025

DOXIL/CAELYX development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

DOXIL/CAELYX clinical trials

DOXIL/CAELYX · 1 trial · 4 indications

Phase 1 1
NCT05567601Doxil/Caelyx BE StudyOvarian Cancer
COMPLETED36 Analytics
PHASE1COMPLETED
Doxil/Caelyx BE Study
Ovarian Cancer
NCT0556760136
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Study Endpoints

Primary Endpoints

Cmax based on encapsulated doxorubicin in patients
Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing

Cmax=maximum observed plasma concentration.

AUC0-t based on encapsulated doxorubicin in patients
Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing

AUC0-t=area under the plasma concentration-time curve from time 0 to time t (interchangeable with AUC0-last).

AUC0-∞ based on encapsulated doxorubicin in patients
Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing

AUC0-∞=area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUClast and Clast/λz, in which Clast is the last observed quantifiable concentration. The reference and the test products will be considered bioequivalent if the three 90% CIs for encapsulated doxorubicin fall within (0.80, 1.25).

Secondary Endpoints

Cmax based on total doxorubicin in patients
Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing
AUC0-t based on total doxorubicin in patients
Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing
AUC0-∞ based on total doxorubicin in patients
Day 1 (Cycle 1) and Day 28 (Cycle 2) at 15 minutes (min) prior to dosing as a baseline measurement and at 15 min, 30 min, 1 hour (h), 1 h 30 min, 1 h 35 min, 1h 45 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, 48 h, 96 h, 168 h, 240 h, 336 h, 504 h post-dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Current Manufacturing SiteACTIVE_COMPARATOROn Day 1 of Cycle 1 of the open-label treatment phase, patients will be randomized to receive drug from either current or new manufacturing site, and then after 28 days cross-over to the drug produced from the other manufacturing site in Cycle 2.
New Manufacturing SiteEXPERIMENTALOn Day 1 of Cycle 1 of the open-label treatment phase, patients will be randomized to receive drug from either current or new manufacturing site, and then after 28 days cross-over to the drug produced from the other manufacturing site in Cycle 2.

Interventions

NameTypeDescription
DOXIL/CAELYXDRUG40 mg/m2 as a 90-minute IV infusion via a central venous catheter or peripheral vein
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. Be a man or woman aged from 18 to 75 years, inclusive. 2. Patients with advanced or refractory ovarian or breast cancer, expected to require at least 2 cycles of DOXIL/CAELYX therapy at Screening, are eligible for treatment per this study protocol. This includes: 1. Histo...

Countries:India
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Competitive Landscape -Ovarian Cancer 244 trials

Top 20 of 60 competitors

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GSK plc Sponsored ADRGSK7PHASE3Niraparib, Dostarlimab, Mocertatug rezetecan
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Merck & Co., Inc.MRK16PHASE3Pembrolizumab, Sacituzumab tirumotecan, Raludotatug Deruxtecan, Patritumab Deruxtecan, MK-6255
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Gemcitabine, Abemaciclib, LY4101174, LY3537982
AbbVie, Inc.ABBV14PHASE3Mirvetuximab soravtansine, Brimonidine eye, IMGN151, ABBV-400, ABBV-901
Bristol-Myers Squibb CompanyBMY4PHASE3Nivolumab, BMS-986340, Pumitamig, BMS-986463, BMS-986500
Genmab A/S Sponsored ADRGMAB7PHASE3Rina-S, GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells
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Novartis AG Sponsored ADRNVS5PHASE2Spartalizumab, Dabrafenib, trametinib, KFA115, Tulmimetostat
Genelux Corp.GNLX1PHASE3Olvimulogene nanivacirepvec
BeOne Medicines Ltd. Sponsored ADRONC3PHASE3Pamiparib, BG-C9074, BG-68501, BGB-43395
Xencor, Inc.XNCR3PHASE2vudalimab, XmAb541, XmAb808
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Frequently asked questions about DOXIL/CAELYX

What is DOXIL/CAELYX used for?

DOXIL/CAELYX is used for ovarian cancer. It is also being studied for AIDS-related Kaposi sarcoma, multiple myeloma, and metastatic breast cancer. It is a small molecule oncology drug being developed by Baxter International Inc. (BAX).

Who makes DOXIL/CAELYX?

DOXIL/CAELYX is being developed by Baxter International Inc., which trades under the ticker BAX. The drug is in Phase 1 clinical development for ovarian cancer.

What phase is DOXIL/CAELYX in?

DOXIL/CAELYX is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is DOXIL/CAELYX in?

DOXIL/CAELYX has one completed clinical trial, NCT05567601, titled "Doxil/Caelyx BE Study." This Phase 1 trial enrolled 36 participants and was conducted in India. The trial was active-controlled and included patients with ovarian cancer, AIDS-related Kaposi sarcoma, multiple myeloma, and metastatic breast cancer.

Is DOXIL/CAELYX the same as Caelyx?

Yes, DOXIL/CAELYX is the same drug, with both names referring to the same product. It is being studied under the name DOXIL/CAELYX in clinical trials.

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