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Trial record 43 of 2158 for:    doxorubicin

Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer (ZoptEC)

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ClinicalTrials.gov Identifier: NCT01767155
Recruitment Status : Completed
First Posted : January 14, 2013
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Endometrial Cancer
Interventions Drug: AEZS-108 / zoptarelin doxorubicin
Drug: doxorubicin
Enrollment 511
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy
Hide Arm/Group Description

267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles

AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles

60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

Period Title: Overall Study
Started [1] 256 [2] 255 [3]
Modified ITT (mITT) [4] 252 249
Safety Population (SAF) 252 249
Completed [5] 243 240
Not Completed 13 15
[1]
Intent-to-treat population (ITT)
[2]
Patients allocated to AEZS-108
[3]
Patients allocated to doxorubicin
[4]
Excluding patients allocated to a treatment but never treated
[5]
Per protocol (PP) population
Arm/Group Title AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy Total
Hide Arm/Group Description

267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles

AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles

60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

Total of all reporting groups
Overall Number of Baseline Participants 256 255 511
Hide Baseline Analysis Population Description
ITT population, comprising all patients allocated to either AEZS-108 or doxorubicin.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 256 participants 255 participants 511 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
130
  50.8%
136
  53.3%
266
  52.1%
>=65 years
126
  49.2%
119
  46.7%
245
  47.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 256 participants 255 participants 511 participants
63.7  (8.63) 63.8  (8.81) 63.7  (8.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 256 participants 255 participants 511 participants
Female
256
 100.0%
255
 100.0%
511
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 256 participants 255 participants 511 participants
White
237
  92.6%
240
  94.1%
477
  93.3%
Black or African American
10
   3.9%
7
   2.7%
17
   3.3%
Asian
6
   2.3%
5
   2.0%
11
   2.2%
Native Hawaiian or Other Pacific Islander
1
   0.4%
1
   0.4%
2
   0.4%
Other
1
   0.4%
2
   0.8%
3
   0.6%
Unknown
1
   0.4%
0
   0.0%
1
   0.2%
ECOG (Eastern Cooperative Oncology Group) PS (Performance Status)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 256 participants 255 participants 511 participants
0
120
  46.9%
125
  49.0%
245
  47.9%
1
121
  47.3%
118
  46.3%
239
  46.8%
2
15
   5.9%
11
   4.3%
26
   5.1%
unknown
0
   0.0%
1
   0.4%
1
   0.2%
[1]
Measure Description:

ECOG PS = Eastern Cooperation Oncology Group Performance Status.

Status Scale Grade:

0: Fully active, able to carry on all pre-disease Performance without restriction.

  1. Symptoms ambulatory, restricted in activity, able to carry out work of light nature
  2. In bed <50% of time, ambulatory + capable of all selfcare, unable to carry out any work activities.
  3. In bed>50% of time, capable of only limited self-care, confirmed to bed or chair >50%.
  4. 100% bedridden, completely disabled, cannot carry on any self-care. 5. Dead
Stage of endometrial cancer at study entry   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 256 participants 255 participants 511 participants
Advanced (FIGO III or IV)
99
  38.7%
94
  36.9%
193
  37.8%
Metastatic
86
  33.6%
90
  35.3%
176
  34.4%
Recurrent
71
  27.7%
71
  27.8%
142
  27.8%
[1]
Measure Description: Advanced disease comprising FIGO (The International Federation of Gynecology and Obstetrics) III or IV
1.Primary Outcome
Title Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin.
Hide Description

Overall survival was defined as the elapsed time from randomization to death from any cause. For surviving patients, follow-up was to be censored at the date of last contact.

The final analysis, which was event-based, was conducted after approximately 384 randomized patients had died.

A log-rank test with an overall two sided Type I Error rate of 0.05 after taking the interim analyses into account was used to compare OS between the two treatment arms via a SAS (Statistical Analysis System) LIFETEST procedure. Kaplan Meier estimates were used to calculate median OS and the 95% confidence interval (CI) of the median OS. The proportion of patients alive at 6 and 12 months (from randomization date) and the 95% CIs for these estimated proportions were calculated.

Time Frame From randomization to death from any cause. During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy
Hide Arm/Group Description:

267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles

AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles

60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

Overall Number of Participants Analyzed 256 255
Measure Type: Number
Unit of Measure: participants
Death Events 196 188
Censored 60 67
Survivors at 6 months 171 174
Survivors at 12 months 111 106
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AEZS-108 / Zoptarelin Doxorubicin
Comments Kaplan-Meier log-log transformed estimates: survivors at 6 months
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier
Estimated Value 69.8
Confidence Interval (2-Sided) 95%
63.6 to 75.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AEZS-108 / Zoptarelin Doxorubicin
Comments Kaplan-Meier log-log transformed estimates: survivors at 12 months
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier
Estimated Value 45.8
Confidence Interval (2-Sided) 95%
39.5 to 52.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doxorubicin/ Standard Chemotherapy
Comments Kaplan-Meier log-log transformed estimates: survivors at 6 months
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier
Estimated Value 72.1
Confidence Interval (2-Sided) 95%
66.0 to 77.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Doxorubicin/ Standard Chemotherapy
Comments Kaplan-Meier log-log transformed estimates: survivors at 12 months
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier
Estimated Value 44.6
Confidence Interval (2-Sided) 95%
38.2 to 50.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection AEZS-108 / Zoptarelin Doxorubicin, Doxorubicin/ Standard Chemotherapy
Comments A Cox model with treatment effects was used to estimate the hazard ratio and perform hypothesis testing. The estimated hazard ratio and the 95% CI of the hazard ratio were presented.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5441
Comments [Not Specified]
Method Log Rank
Comments 2-sided
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.87 to 1.30
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Compare Efficacy Based on Objective Response Rate (ORR).
Hide Description

The ORR was defined as the sum of the Complete Response (CR) and Partial Response (PR).

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm.

PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy
Hide Arm/Group Description:

267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles

AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles

60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

Overall Number of Participants Analyzed 256 255
Measure Type: Count of Participants
Unit of Measure: Participants
CR
6
   2.3%
5
   2.0%
PR
26
  10.2%
31
  12.2%
ORR
32
  12.5%
36
  14.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AEZS-108 / Zoptarelin Doxorubicin, Doxorubicin/ Standard Chemotherapy
Comments Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test. The odds ratio and 95% CI of the odds ratio were presented.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5907
Comments [Not Specified]
Method Mantel Haenszel
Comments 2-sided test
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.52 to 1.45
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Compare Efficacy Based on Progression-free Survival (PFS).
Hide Description

Progression-free survival (PFS): days between randomization and the date of documented progression or death for any cause that occurred up to the end of the study. For patients whose progression status could not be determined, their PFS data was censored for the last adequate progression assessment date that the patient was confirmed to have no progression.

Response and progression were to be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (uni-dimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes were to be used.

During ongoing treatment, patients were to be re-evaluated for response every 3 cycles (i.e. every 9 weeks).

A subsequent scan was obtained no earlier than 4 weeks following the initial documentation of an objective status of either complete response (CR) or partial response (PR).

Time Frame During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed is the mITT. PFS was analyzed in the subset of patients from mITT that have CR, PR or stable disease (SD) as best overall response.
Arm/Group Title AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy
Hide Arm/Group Description:

267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles

AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles

60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

Overall Number of Participants Analyzed 252 249
Measure Type: Count of Participants
Unit of Measure: Participants
PFS events
166
  65.9%
148
  59.4%
Censored
90
  35.7%
107
  43.0%
Progression Free Survivors at 6 months
69
  27.4%
51
  20.5%
Progression Free Survivors at 12 months
28
  11.1%
12
   4.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AEZS-108 / Zoptarelin Doxorubicin
Comments Kaplan-Meier log-log transformed estimates: survivors at 6 months.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier
Estimated Value 46.7
Confidence Interval (2-Sided) 95%
39.5 to 53.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AEZS-108 / Zoptarelin Doxorubicin
Comments Kaplan-Meier log-log transformed estimates: survivors at 12 months
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier
Estimated Value 20.6
Confidence Interval (2-Sided) 95%
14.6 to 27.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Doxorubicin/ Standard Chemotherapy
Comments Kaplan-Meier log-log transformed estimates: survivors at 6 months
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier
Estimated Value 47.5
Confidence Interval (2-Sided) 95%
40.0 to 54.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Doxorubicin/ Standard Chemotherapy
Comments Kaplan-Meier log-log transformed estimates: survivors at 12 months
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier
Estimated Value 12.3
Confidence Interval (2-Sided) 95%
6.9 to 19.3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection AEZS-108 / Zoptarelin Doxorubicin, Doxorubicin/ Standard Chemotherapy
Comments Hypothesis testing between the two treatment arms was performed using a log rank test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3089
Comments [Not Specified]
Method Log Rank
Comments 2-sided
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.71 to 1.11
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Compare Efficacy Based on Clinical Benefit Rate (CBR).
Hide Description

Clinical benefit was defined as having stable disease (SD) or better lasting for at least 9 weeks. The CBR was analyzed using the same methods for the ORR analyses. The analysis of CBR (CR+PR+SD) was performed in the ITT (intention-to-treat) population.

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm.

PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy
Hide Arm/Group Description:

267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles

AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles

60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

Overall Number of Participants Analyzed 256 255
Measure Type: Count of Participants
Unit of Measure: Participants
CR
6
   2.3%
5
   2.0%
PR
26
  10.2%
31
  12.2%
SD
106
  41.4%
102
  40.0%
Progressive Disease (PD)
65
  25.4%
67
  26.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AEZS-108 / Zoptarelin Doxorubicin, Doxorubicin/ Standard Chemotherapy
Comments Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6924
Comments [Not Specified]
Method Mantel Haenszel
Comments 2-sided
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.76 to 1.52
Estimation Comments [Not Specified]
Time Frame Approx. over 3 years, during the whole duration of the trial.
Adverse Event Reporting Description The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 4.03 or subsequent ones) were to be used for the grading of severity of symptoms and abnormal findings.
 
Arm/Group Title AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy
Hide Arm/Group Description

267 mg/m^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles

AEZS-108 / zoptarelin doxorubicin: 267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles

60 mg/m^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

All-Cause Mortality
AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   196/252 (77.78%)   188/249 (75.50%) 
Show Serious Adverse Events Hide Serious Adverse Events
AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   92/252 (36.51%)   75/249 (30.12%) 
Blood and lymphatic system disorders     
Neutropenia  1  21/252 (8.33%)  15/249 (6.02%) 
Anemia  1  16/252 (6.35%)  9/249 (3.61%) 
Febrile neutropenia  1  17/252 (6.75%)  8/249 (3.21%) 
Thrombocytopenia  1  8/252 (3.17%)  3/249 (1.20%) 
Leukopenia  1  4/252 (1.59%)  6/249 (2.41%) 
Gastrointestinal disorders     
Nause  1  11/252 (4.37%)  8/249 (3.21%) 
Vomiting  1  7/252 (2.78%)  9/249 (3.61%) 
Intestinal obstruction  1  6/252 (2.38%)  2/249 (0.80%) 
Abdominal pain  1  5/252 (1.98%)  3/249 (1.20%) 
Small intestinal obstruction  1  3/252 (1.19%)  4/249 (1.61%) 
Metabolism and nutrition disorders     
Dehydratation  1  8/252 (3.17%)  2/249 (0.80%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  7/252 (2.78%)  5/249 (2.01%) 
Dyspnoe  1  6/252 (2.38%)  1/249 (0.40%) 
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AEZS-108 / Zoptarelin Doxorubicin Doxorubicin/ Standard Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   239/252 (94.84%)   240/249 (96.39%) 
Blood and lymphatic system disorders     
Neutropenia  1  132/252 (52.38%)  126/249 (50.60%) 
Aneamia  1  107/252 (42.46%)  101/249 (40.56%) 
Gastrointestinal disorders     
Nausea  1  120/252 (47.62%)  125/249 (50.20%) 
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
According to the study protocol, "draft versions of abstracts or manuscripts must be made available to the co-authors and to the sponsor before any presentation of results or submission for publication. At least 3 weeks should be allowed for review and comment of an abstract and 4 weeks in case of a full paper, respectively. Multiple review cycles are usual for full papers and respective planning must account for this." In addition, the definitions per individual trial site agreement did apply.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nicola Ammer
Organization: Aeterna Zentaris
Phone: +496942602 ext 3472
EMail: nammer@aezsinc.com
Layout table for additonal information
Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01767155     History of Changes
Other Study ID Numbers: AEZS-108-050
First Submitted: January 9, 2013
First Posted: January 14, 2013
Results First Submitted: January 15, 2018
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018