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Panzem NCD

Phase 2

Metastatic Renal Cell Carcinoma | Small molecule | Oncology |CASI Pharmaceuticals, Inc.|Last Updated: Aug 4, 2011

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

Panzem NCD · 3 trials · 3 indications

Phase 2 3
NCT00481455Phase 2 Study of Panzem Nanocrystal Colloidal Dispersion (NCD) in Combination With Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme (GBM)Recurrent Glioblastoma Multiforme
COMPLETED15 Analytics
NCT00444314Phase 2 Study of Panzem® NCD Alone and Combined With Sunitinib Malate in Patients With Metastatic Renal Cell CarcinomaMetastatic Renal Cell Carcinoma
COMPLETED82 Analytics
NCT00394810Efficacy and Pharmacodynamic Study of Panzem® NCD in Patients With Hormone-Refractory Prostate CancerProstate Cancer
COMPLETED21 Analytics
PHASE2COMPLETED
Phase 2 Study of Panzem Nanocrystal Colloidal Dispersion (NCD) in Combination With Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme (GBM)
Recurrent Glioblastoma MultiformeUnlock trial analytics
PHASE2COMPLETED
Phase 2 Study of Panzem® NCD Alone and Combined With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma
Metastatic Renal Cell CarcinomaUnlock trial analytics
PHASE2COMPLETED
Efficacy and Pharmacodynamic Study of Panzem® NCD in Patients With Hormone-Refractory Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

6-month progression free survival and median overall survival for patients receiving at least one dose
Every 2 cycles
To assess the objective response rate of Panzem NCD alone and in combination with Sunitinib Malate
Throughout study participation
6 month progression free survival
at time of progression
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
AEXPERIMENTAL -
BEXPERIMENTAL -

Interventions

NameTypeDescription
Panzem NCDDRUG2000 mg q8h, continuous dosing in 28 day cycles
TemozolomideDRUGFixed dose
Panzem® NCDDRUGNCD suspension, 1500 mg TID daily for 6 week cycles
Sunitinib MalateDRUGSunitinib Malate, highest tolerated dose (patient's current dose), daily oral administration for 4 weeks, with 2 week break in 6 week cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. A histologically confirmed diagnosis of a recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma). Patients with recurrent disease whose diagnostic pathology confirmed WHO grade IV malignant glioma (glioblastoma multiforme or glios...

Countries:United States
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Frequently asked questions about Panzem NCD

What is Panzem NCD used for?

Panzem NCD is an investigational small molecule being studied for the treatment of metastatic renal cell carcinoma, prostate cancer, and recurrent glioblastoma multiforme. It is being developed by CASI Pharmaceuticals, Inc. (NASDAQ: CASI) and is currently in Phase 2 clinical development.

What does Panzem NCD target?

The specific molecular target of Panzem NCD has not been disclosed in available information. It is a small molecule oncology agent being investigated for its anti-cancer activity in multiple tumor types, including metastatic renal cell carcinoma, prostate cancer, and recurrent glioblastoma multiforme.

Who makes Panzem NCD?

Panzem NCD is being developed by CASI Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CASI. The company is conducting clinical trials of this investigational drug in oncology indications.

What phase is Panzem NCD in?

Panzem NCD is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed clinical trials for Panzem NCD were Phase 2 studies, and the drug remains under investigation for its safety and efficacy.

What clinical trials is Panzem NCD in?

Panzem NCD has completed three Phase 2 clinical trials: NCT00394810 in hormone-refractory prostate cancer, NCT00444314 in metastatic renal cell carcinoma alone and with sunitinib, and NCT00481455 in recurrent glioblastoma multiforme with temozolomide. All trials were conducted in the United States.

Is Panzem NCD the same as Panzem?

Panzem NCD is a specific formulation of the drug Panzem, using nanocrystal colloidal dispersion technology. The clinical trials listed under Panzem NCD evaluate this particular formulation in prostate cancer, renal cell carcinoma, and glioblastoma multiforme.