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2-methoxyestradiol

Phase 2

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

2-methoxyestradiol development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Mar 2006

2-methoxyestradiol target and mechanism

ModalitySmall molecule

Also known as Panzem, Panzem NCD, 2ME2, Panzem Nanocrystal Colloidal Dispersion

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment105

FDA Designations

No designations recorded

2-methoxyestradiol clinical trials

2-methoxyestradiol · 3 trials · 4 indications

Phase 2 3
NCT00400348Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion in Patients With Ovarian CancerOvarian Cancer
COMPLETED18 Analytics
NCT00306618Safety and Efficacy Study of Panzem NCD to Treat GlioblastomaRecurrent Glioblastoma Multiforme
COMPLETED27 Analytics
NCT00592579A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple MyelomaRelapsed Multiple Myeloma
COMPLETED60 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion in Patients With Ovarian Cancer
Ovarian CancerUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
Recurrent Glioblastoma MultiformeUnlock trial 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

Assess the safety of oral doses of Panzem NCD administered to patients with recurrent epithelial ovarian cancer
Throughout study participation
6 month progression free survival and median overall survival
time of progression; survival
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
Panzem Nanocrystal Colloidal Dispersion (NCD)DRUGPanzem NCD 1,000 mg, four times daily for 28 consecutive days
Panzem Nanocrystal Colloidal DispersionDRUGPanzem NCD suspension, 100 mg/mL, four times daily continuous dosing
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
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of protected health information. 2. Have histologically-confirmed: * epithelial ovarian cancer or * primary peritoneal carcinomatosis or * fallopian tube cancer. Enrollment of patients with clear cell hist...

Countries:United States
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Competitive Landscape -Multiple Myeloma 343 trials (matched to "Relapsed Multiple Myeloma")

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.