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2-methoxyestradiol

Phase 2

Relapsed Multiple Myeloma | Small molecule | Oncology |CASI Pharmaceuticals, Inc.|Last Updated: Feb 26, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

2-methoxyestradiol · 1 trial · 2 indications

Phase 2 1
NCT00592579A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple MyelomaRelapsed Multiple Myeloma
COMPLETED60 Analytics
PHASE2COMPLETED
A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma
Relapsed Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma
At least yearly

Secondary Endpoints

To assess the safety and tolerability of 2ME2 administered orally by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in patients with plateau phase or relapsed multiple myeloma
As reported
To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma
At least yearly
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALOpen label, oral administration of 2ME2

Interventions

NameTypeDescription
2-methoxyestradiolDRUG800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Have plateau phase (patients who have been previously treated with at least one conventional or high-dose chemotherapy who are currently off all therapy for at least 4 weeks and are considered to have stable disease) or relapsed MM. Patients in plateau phase must have M-prote...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials (matched to "Relapsed Multiple Myeloma")

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol / Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about 2-methoxyestradiol

What is 2-methoxyestradiol used for?

2-methoxyestradiol is an investigational small molecule being studied for the treatment of relapsed multiple myeloma. It is being developed by CASI Pharmaceuticals, Inc. (NASDAQ: CASI) and is currently in Phase 2 clinical development. The drug is intended for patients with relapsed or plateau phase multiple myeloma.

Who makes 2-methoxyestradiol?

2-methoxyestradiol is being developed by CASI Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CASI. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with relapsed multiple myeloma.

What phase is 2-methoxyestradiol in?

2-methoxyestradiol is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 study of the drug in patients with relapsed or plateau phase multiple myeloma has been completed.

What clinical trials is 2-methoxyestradiol in?

2-methoxyestradiol has one completed clinical trial, identified as NCT00592579, titled "A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma." This Phase 2 study enrolled 60 participants in the United States and was not randomized or double-blinded.

Is 2-methoxyestradiol the same as Panzem?

Yes, 2-methoxyestradiol is also known as Panzem. The Phase 2 clinical trial NCT00592579, which evaluated the drug in patients with relapsed or plateau phase multiple myeloma, used the name Panzem in its title. Both names refer to the same investigational drug.