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Panzem Nanocrystal Colloidal Dispersion

Phase 2

Ovarian Cancer | Small molecule | Oncology |CASI Pharmaceuticals, Inc.|Trials Updated: Feb 26, 2009

Panzem Nanocrystal Colloidal Dispersion development status

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

Panzem Nanocrystal Colloidal Dispersion target and mechanism

ModalitySmall molecule

Also known as Panzem Nanocrystal Colloidal Dispersion (NCD), 2-methoxyestradiol, 2ME2

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment105

FDA Designations

No designations recorded

Panzem Nanocrystal Colloidal Dispersion clinical trials

Panzem Nanocrystal Colloidal Dispersion · 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 -Ovarian Cancer 244 trials

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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
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Frequently asked questions about Panzem Nanocrystal Colloidal Dispersion

What is Panzem Nanocrystal Colloidal Dispersion used for?

Panzem Nanocrystal Colloidal Dispersion is an investigational small molecule being studied in oncology for the treatment of ovarian cancer and recurrent glioblastoma multiforme. It has been evaluated in Phase 2 clinical trials in patients with these tumor types. It is not approved for commercial use.

Who is developing Panzem Nanocrystal Colloidal Dispersion?

Panzem Nanocrystal Colloidal Dispersion is being developed by CASI Pharmaceuticals, Inc., which trades under the ticker CASI. The company is the sponsor of the clinical program for this agent in ovarian cancer and recurrent glioblastoma multiforme.

What phase is Panzem Nanocrystal Colloidal Dispersion in?

Panzem Nanocrystal Colloidal Dispersion is in Phase 2 clinical development. It has completed Phase 2 trials in ovarian cancer and recurrent glioblastoma multiforme. No Phase 3 trials have been initiated, and the drug remains investigational.

What clinical trials is Panzem Nanocrystal Colloidal Dispersion in?

Panzem Nanocrystal Colloidal Dispersion has been studied in two completed Phase 2 trials: NCT00400348 in ovarian cancer, which enrolled 18 female patients, and NCT00306618 in recurrent glioblastoma multiforme, which enrolled 27 patients. Both trials were conducted in the United States and are now completed.

Is Panzem Nanocrystal Colloidal Dispersion the same as Panzem NCD?

Yes, Panzem Nanocrystal Colloidal Dispersion is also known as Panzem NCD. The abbreviation NCD stands for Nanocrystal Colloidal Dispersion. Both names refer to the same investigational small molecule developed by CASI Pharmaceuticals for oncology indications.