Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066885
Status:
COMPLETED
Last Update Posted:
2007-05-07
First Post:
2003-08-06
Brief Title:
Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Novacea
Organization:
Novacea
Study Overview
Official Title:
A Phase 12 Multicenter Open Label Dose Ranging Study of DN-101 and Taxotere in Patients With Advanced Stage IIIB or IV Non-Small Cell Lung Cancer NSCLC Who Have Failed Previous Therapy With Platinum-Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 12 clinical trial is a multi-center open-label study with three main objectives The first Phase 1A is to determine the maximum-tolerated dose of DN-101 when administered in combination with Taxotere docetaxel every three weeks closed The second is to determine the maximum-tolerated dose of DN-101 when administered weekly in combination with Taxoteredocetaxeldevery three weeks open The third is to evaluate the safety and objective tumor response rate of the combination in NSCLC DN-101 doses will be escalated at three dosing levels Patients will receive oral DN-101 on day one followed by intravenous docetaxel on day two of a 21-day cycle Treatment cycles will be repeated at the same dose level each 21 days until disease progression or unacceptable toxicity
Detailed Description:
DN-101 is an oral anti-cancer therapy for solid tumors and various hematologic malignancies DN-101 is a unique formulation of calcitriol specifically designed for use in cancer Calcitriol is a naturally occurring hormone and the most potent biologically active form of vitamin D In high doses calcitriol is active in many laboratory and animal models of cancer and synergistic with many commonly used chemotherapeutic agents Until recently the clinical use of calcitriol as an anti-cancer therapy was limited by hypercalcemia at doses required for anti-tumor activity Based upon clinical results to date Novacea believes it has successfully developed a solution to this problem through development of DN-101
Chemotherapy for NSCLC while not curative has been shown to prolong survival in patients with unresectable disease A number of different chemotherapy agents have been shown to have single-agent activity in NSCLC These include cisplatin carboplatin vinorelbine gemcitabine paclitaxel and docetaxel For first-line therapy of Stage IIIB or Stage IV NSCLC these agents are generally used in combination In most cases first-line chemotherapy consists of a platinum-based agent either cisplatin or carboplatin and another chemotherapeutic
Only one agent Taxotere has been approved in the United States by the Food and Drug Administration for use as second-line chemotherapy in NSCLC
Chemotherapy for NSCLC while not curative has been shown to prolong survival in patients with unresectable disease A number of different chemotherapy agents have been shown to have single-agent activity in NSCLC These include cisplatin carboplatin vinorelbine gemcitabine paclitaxel and docetaxel For first-line therapy of Stage IIIB or Stage IV NSCLC these agents are generally used in combination In most cases first-line chemotherapy consists of a platinum-based agent either cisplatin or carboplatin and another chemotherapeutic
Only one agent Taxotere has been approved in the United States by the Food and Drug Administration for use as second-line chemotherapy in NSCLC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None