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Also known as Oxidized Glutathione
NOV-002 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Group A: NOV-002 plus Chemotherapy | EXPERIMENTAL | NOV-002 in combination with Paclitaxel and Carboplatin |
| Group B: Chemotherapy Alone | ACTIVE_COMPARATOR | Paclitaxel and Carboplatin |
| NOV-002 plus Carboplatin | EXPERIMENTAL | NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles. |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Paclitaxel is dosed at 200 mg/m2, as a 3 hour infusion. All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first. |
| NOV-002 | DRUG | * Two 60 mg intravenous boli given 3 hours apart administered the day prior to the first administration of paclitaxel and carboplatin cycle one * For each nominal 21-day paclitaxel and carboplatin cycle: * 60 mg given intravenously on Day 1, given one hour prior to paclitaxel and carboplatin * followed by 60 mg subcutaneously daily for the next 20 days. If there is a delay in chemotherapy cycles, the patient will continue with daily, subcutaneous administration of NOV-002 until the next cycle of chemotherapy begins Patients randomized to NOV-002 Group A, will receive NOV-002 until disease progression, unacceptable NOV-002 related toxicity, or discontinuation of paclitaxel and carboplatin, whichever comes first. |
| Carboplatin | DRUG | Carboplatin is dosed at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing. All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first. The initial dose of chemotherapy for every patient in the trial is 200 mg/m2 of paclitaxel, as a 3 hour infusion, followed by carboplatin at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing. |
Inclusion Criteria: * Diagnosis of Stage IIIb with malignant pleural or pericardial effusion or Stage IV (American Joint Committee on Cancer \[AJCC\]) NSCLC * ECOG performance score of 0 or 1 * Adequate bone marrow, hepatic, and renal function * New York Heart Association (NYHA) score 1-2 * Life ex...
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NOV-002 is an investigational small molecule being studied for the treatment of Non Small Cell Lung Cancer and Ovarian Cancer. It is developed by Cellectar Biosciences, Inc. (NASDAQ: CLRB). The drug is not approved and remains in clinical development.
NOV-002 is being developed by Cellectar Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CLRB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.
NOV-002 has completed a Phase 3 clinical trial in Non Small Cell Lung Cancer and a Phase 2 trial in Ovarian Cancer. It is an investigational drug and has not received FDA approval. Currently, there are no active trials listed for NOV-002.
NOV-002 has completed two clinical trials. NCT00347412 was a Phase 3 study in Non Small Cell Lung Cancer with 903 participants, conducted in multiple countries. NCT00345540 was a Phase 2 study in Ovarian Cancer with 15 participants, conducted in the United States.
NOV-002 is the primary name for this investigational drug. No alternative names have been reported. It is a small molecule being studied for its potential role in treating Non Small Cell Lung Cancer and Ovarian Cancer.