Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Lymphangioleiomyomatosis
Interventions
DRUG

"Sirolimus and Hydroxychloroquine 200 mg"

"This will be a phase I dose escalation study of the combination of Sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and Hydroxychloroquine 200 mg taken orally daily."

DRUG

"Sirolimus and Hydroxychloroquine 400 mg"

Once safety is established with the lower dose, (Sirolimus and Hydroxychloroquine 200 mg), subjects will receive Sirolimus 2 mg (adjusted to keep trough levels between 5 to 15 ng/ml) and hydroxychloroquine 200 mg twice a day.

Trial Locations (1)

02120

Brigham and Women's Hospital, Boston

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Brigham and Women's Hospital

OTHER

NCT01687179 - Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis | Biotech Hunter | Biotech Hunter