Recent Updates
Recently added Catalysts

DOXIL/CAELYX

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

DOXIL/CAELYX · 1 trial · 4 indications

Phase 1 1
NCT05567601Doxil/Caelyx BE StudyOvarian Cancer
COMPLETED36 Analytics
PHASE1COMPLETED
Doxil/Caelyx BE Study
Ovarian Cancer
NCT0556760136
Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
Unlock Competitive Intelligence

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.