Genzyme, a Sanofi Company clinical trial failures

Phase III Tay-Sachs Disease trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

Discontinued based on the absence of positive trends on clinical endpoints.

Phase III Multiple Sclerosis trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Enrolment formally closed earlier than planned due to recruitment challenges.

Phase II Alport Syndrome trial by Genzyme, a Sanofi Company. Stop reason: EFFICACY/FUTILITY.

The results of the futility analysis led to the study termination. No unexpected safety findings were identified.

Phase IV Fabry Disease trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Per FDA decision, the 2003 Post Marketing commitment has been fulfilled.

Phase IV Mucopolysaccharidosis I trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Study was conducted to fulfill a post marketing commitment (PMC). FDA acknowledged closure of PMC.

Phase II Polycystic Kidney, Autosomal Dominant trial by Genzyme, a Sanofi Company. Stop reason: EFFICACY/FUTILITY.

Interim analysis for futility of the Stage 1 of the EFC15392 study met the protocol specified stopping rule based on the primary endpoint. EFC15392 study was stopped for futility based on prespecified criteria and recommendation from DMC

Phase II Parkinson's Disease trial by Genzyme, a Sanofi Company. Stop reason: EFFICACY/FUTILITY.

The topline results of the 52-week double-blind placebo-controlled period were analyzed. The study did not meet the primary or secondary endpoints. Based on these results, the decision was made to halt the long-term follow-up period of the study

Phase IV Pompe Disease trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Study was conducted to fulfill a post marketing commitment (PMC 6). FDA acknowledged fulfillment of PMC.

Phase I Fabry Disease trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Enrollment period not extended and screening stopped for slow recruitment and in accordance with provisions of the protocol. Not linked to any safety concern

Phase II Endometrial Cancer trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Fallopian Tube Cancer trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Prostate Cancer trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Slow recruitment

Phase II Relapsing-remitting Multiple Sclerosis trial by Genzyme, a Sanofi Company. Stop reason: EFFICACY/FUTILITY.

Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.

Phase II Relapsing-remitting Multiple Sclerosis trial by Genzyme, a Sanofi Company. Stop reason: EFFICACY/FUTILITY.

Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.

Phase II Breast Cancer trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Mesothelioma trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Recruitment stopped according to early stopping rule (by protocol)

Phase I Ovarian Cancer trial by Genzyme, a Sanofi Company. Stop reason: EFFICACY/FUTILITY.

Lack of efficacy

Phase IV Pompe Disease (Infantile-Onset) trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

Study was stopped due to approved label expansion of alglucosidase alfa.

Phase IV Pompe Disease trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

Terminated due to approved label expansion

Phase II Ischemic Heart Failure trial by Genzyme, a Sanofi Company. Stop reason: SAFETY.

DMC recommended stop

Phase I Myelodysplastic Syndromes trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

Terminated to focus on comparable trial, CLOMDS02507

Phase II Multiple Myeloma trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Enrollment terminated in 2005 to focus on Phase 3 study enrollment.

Phase I Carcinoma, Hepatocellular trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

This study was terminated early by Genzyme because there were insufficient data to support clinical benefit to HCC patients on the study.

Phase I Idiopathic Thrombocytopenic Purpura trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Study terminated due to low enrollment.

Phase II Fabry Disease trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

The trial was terminated early due to inadequate study design.

Phase II Myelodysplastic Syndrome (MDS) trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Study terminated due to slow enrollment.

Phase I Non-Hodgkin's Lymphoma trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase III Chronic Kidney Disease trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

After an extensive review,the ASPIRE in CKD study was terminated because it was not possible to complete the study in an appropriate time frame.

Phase I Acid Sphingomyelinase Deficiency trial by Genzyme, a Sanofi Company. Stop reason: OPERATIONAL.

Terminated by sponsor - Single dose safety objective achieved.

Phase III Enterocolitis, Pseudomembranous trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase I Non-Hodgkins Lymphoma trial by Genzyme, a Sanofi Company. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.