Recent Updates
Recently added Catalysts

Panzem NCD, Avastin

Phase 2

Carcinoid Tumor | Small molecule | Oncology |CASI Pharmaceuticals, Inc.|Last Updated: Aug 4, 2011

Target and mechanism

ModalitySmall molecule

Also known as Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab), Panzem NCD, Panzem® NCD

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Panzem NCD, Avastin · 4 trials · 4 indications

Phase 2 4
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
NCT00328497A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid TumorsCarcinoid Tumor
COMPLETED31 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
PHASE2COMPLETED
A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid Tumors
Carcinoid TumorUnlock 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
To assess the safety of Panzem NCD administered orally in combination with intravenous infusion of bevacizumab by evaluation of the frequency and severity of treatment emergent adverse events
Approximately monthly
To evaluate the objective tumor response rate by radiographic means using Response Evaluation Criteria in Solid Tumors
Approximately every 8 weeks
To determine the overall survival of patients with locally advanced or metastatic carcinoid tumors administered oral Panzem NCD in combination with intravenous infusion of bevacizumab
Approximately every 3 months

Secondary Endpoints

To determine the progression-free survival of patients with locally advanced or metastatic carcinoid tumors administered oral Panzem NCD in combination with intravenous infusion of bevacizumab
Approximately every 3 months
To monitor the steady-state trough plasma levels of 2ME2 following 28-day dosing cycles of Panzem NCD when administered orally in combination with intravenous infusion of bevacizumab
Approximately monthly
Unlock Study Endpoints

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
Panzem (2-methoxyestradiol) NCD, Avastin (Bevacizumab)DRUGPanzem NCD 1,000 mg, four times daily for 28 consecutive days bevacizumab 5 mg/kg intravenous bolus on Day 1 and Day 15
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Panzem NCD, Avastin

What is Panzem NCD?

Panzem NCD is an investigational small molecule cancer therapy developed by CASI Pharmaceuticals, Inc. (ticker CASI). It has been studied in Phase 2 clinical trials for carcinoid tumor, metastatic renal cell carcinoma, prostate cancer, and recurrent glioblastoma multiforme. It is also known as 2-methoxyestradiol nanocrystal colloidal dispersion.

What is Panzem NCD used for?

Panzem NCD has been studied in Phase 2 trials for several cancers: carcinoid tumor, metastatic renal cell carcinoma, hormone-refractory prostate cancer, and recurrent glioblastoma multiforme. It has been tested both as a single agent and in combination with other therapies such as temozolomide, sunitinib malate, and Avastin (bevacizumab).

Who makes Panzem NCD?

Panzem NCD is developed by CASI Pharmaceuticals, Inc., which trades under the ticker CASI. The company has sponsored Phase 2 clinical studies of the drug across multiple oncology indications, including carcinoid tumor, metastatic renal cell carcinoma, prostate cancer, and recurrent glioblastoma multiforme.

What phase is Panzem NCD in?

Panzem NCD is in Phase 2 clinical development. All four of its registered trials were Phase 2 studies, and all have been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is Panzem NCD in?

Panzem NCD has been evaluated in four completed Phase 2 trials: NCT00481455 in recurrent glioblastoma multiforme with temozolomide, NCT00444314 in metastatic renal cell carcinoma alone and with sunitinib malate, NCT00394810 in hormone-refractory prostate cancer, and NCT00328497 in metastatic carcinoid tumors with Avastin.

Is Panzem NCD the same as Avastin?

No. Panzem NCD and Avastin are different drugs. Panzem NCD, also called 2-methoxyestradiol NCD, is a small molecule developed by CASI Pharmaceuticals. Avastin, also known as bevacizumab, was studied in combination with Panzem NCD in a Phase 2 trial in metastatic carcinoid tumors (NCT00328497).