Who is sponsoring NCT00669747?

NCT00669747 is sponsored by Windy Hill Medical, Inc..

What condition does NCT00669747 study?

NCT00669747 studies Ductal Carcinoma In Situ.

What drugs are being tested in NCT00669747?

Interventions: Carboplatin i.d. Days 1 & 15, Carboplatin i.d. Day 1; Normal Saline i.d. Day 15, Normal Saline.

What is the status of NCT00669747?

NCT00669747 is currently UNKNOWN.

Last reviewed 2008-10-01 · How we verify

A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ

NCT00669747 Phase 2 UNKNOWN

The primary objective of this study is to compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion. Secondary objectives are to characterize the biologic and clinical effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram, histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.

Details

Lead sponsor	Windy Hill Medical, Inc.
Phase	Phase 2
Status	UNKNOWN
Enrolment	45
Start date	2008-05
Completion	2009-12

Conditions

Ductal Carcinoma In Situ

Interventions

Carboplatin i.d. Days 1 & 15
Carboplatin i.d. Day 1; Normal Saline i.d. Day 15
Normal Saline

Primary outcomes

Compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion — 2 to 4 weeks following the Day 15 intraductal infusion

Countries

United States