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A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

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ClinicalTrials.gov Identifier: NCT01840943
Recruitment Status : Terminated (the study was terminated due to medication supply issue from current manufacturer)
First Posted : April 26, 2013
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epithelial Ovarian Cancer
Interventions Drug: CAELYX
Drug: Topotecan HCl
Enrollment 32
Recruitment Details  
Pre-assignment Details Out of 32 participants screened, 26 were randomized to study treatment.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks. Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Period Title: Overall Study
Started 14 12
Completed 1 0
Not Completed 13 12
Reason Not Completed
Withdrawal by Subject             5             6
Physician Decision             4             2
Lost to Follow-up             4             4
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl) Total
Hide Arm/Group Description Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks. Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle. Total of all reporting groups
Overall Number of Baseline Participants 14 12 26
Hide Baseline Analysis Population Description
The modified intent-to-treat population included (mITT) included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 26 participants
56.1  (4.97) 51.6  (8.32) 54.0  (6.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
Female
14
 100.0%
12
 100.0%
26
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Progression-free Survival Incidence at Week 24
Hide Description Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat population included (mITT) included all randomized participants.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 14 12
Measure Type: Number
Unit of Measure: participants
6 2
2.Secondary Outcome
Title Duration of Progression-free Survival
Hide Description It was calculated as the time, in weeks, from the day of randomization until documented disease progression or death due to any cause, whichever occurs first using a Kaplan-Meier curve for PFS.
Time Frame 1 year after the last dose (24 weeks) administration
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 14 12
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(8.0 to NA)
24.6
(7.9 to 25.1)
[1]
Insufficient number of participants with events.
3.Secondary Outcome
Title Number of Participants With Response
Hide Description Response rate was measured as number of participants with at least a durable response: Complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Partial response is defined as at least a 30 percentage decrease in the sum of diameters of target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progression in disease is defined as at least a 20% increase in the sum of diameters of target lesions. Not evaluable participants were those who were not analyzed. The reference of the baseline sum of diameters of lesions was considered.
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 14 12
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0 0
Partial Response (PR) 5 3
Stable Disease (SD) 4 6
Progression Disease (PD) 1 1
Not Evaluable (NE) 4 2
4.Secondary Outcome
Title Time to Response
Hide Description It is calculated as the day of randomization to the first observation of a durable response (the first of the 2 confirmatory measurements).
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants.Time to response was analyzed for participants who achieved response.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 5 3
Median (Full Range)
Unit of Measure: weeks
16.0
(8.0 to 24.1)
16.0
(6.0 to 16.1)
5.Secondary Outcome
Title Duration of Response
Hide Description It is calculated as the first observation of a durable response (the first of the 2 confirmatory measurements) to the first observation of disease progression or death due to any cause.
Time Frame Up to 1 year of last dose (Week 24) administration
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants. Duration of response was analyzed for participants who achieved response.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 5 3
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(8.1 to NA)
9.3
(8.6 to 10.6)
[1]
Insufficient number of participants with events.
6.Secondary Outcome
Title Health-related Quality of Life Assessment (HQL)
Hide Description Calculation of each HQL domain scale will be performed according to the scoring guidelines for each of the HQL measures. The HQL analyses will include scales measuring physical functioning, pain, nausea, fatigue, and global quality of life. Each item is measured on a scale of 0 to 3, where 0 = no impact on quality of life and 3 = extreme impact on quality of life.
Time Frame Day 1 of each cycle of study medication and Week 4 after last dose of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure as the study was early terminated.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With Overall Survival
Hide Description Number of Participants With Overall survival were categorized as number of 1) Deaths, 2) Still alive, 3) Early termination from the study due to lost to follow up, 4) Early termination from the study due to withdraw of consent, 5) Other. Overall survival is defined as the time interval from randomization to death from any cause.
Time Frame Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population included all randomized participants.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 14 12
Measure Type: Number
Unit of Measure: participants
Death 1 0
Still alive 0 0
Early termination: due to lost to follow up 4 4
Early termination: due to withdraw of consent 5 6
Other 4 2
8.Secondary Outcome
Title Maximum Plasma Concentration of CAELYX
Hide Description [Not Specified]
Time Frame 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure as the study was early terminated.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Time to Reach the Maximum Plasma Concentration of CAELYX
Hide Description [Not Specified]
Time Frame 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure as the study was early terminated.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Area Under the Plasma Concentration of CAELYX
Hide Description [Not Specified]
Time Frame 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure as the study was early terminated.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Apparent Terminal Elimination Half-life of Plasma Concentration of CAELYX
Hide Description [Not Specified]
Time Frame 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure as the study was early terminated.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Apparent Terminal Elimination Rate Constant of Plasma Concentration of CAELYX
Hide Description [Not Specified]
Time Frame 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure as the study was early terminated.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Systemic Clearance of Plasma Concentration of CAELYX
Hide Description [Not Specified]
Time Frame 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure as the study was early terminated.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Apparent Volume of Distribution of Plasma Concentration of CAELYX
Hide Description [Not Specified]
Time Frame 0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure as the study was early terminated.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events are symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events are Symptoms causing inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.
Time Frame Up to 30 days after the last dose of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants.
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description:
Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
Overall Number of Participants Analyzed 14 12
Measure Type: Number
Unit of Measure: participants
TEAEs 12 12
TESAEs 1 1
Time Frame Up to 30 days after the last dose of study medication
Adverse Event Reporting Description Safety population included all randomized participants.
 
Arm/Group Title CAELYX Topotecan Hydrocloride (HCl)
Hide Arm/Group Description Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks. Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
All-Cause Mortality
CAELYX Topotecan Hydrocloride (HCl)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CAELYX Topotecan Hydrocloride (HCl)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/14 (7.14%)   1/12 (8.33%) 
Infections and infestations     
Pulmonary tuberculosis * 1  1/14 (7.14%)  0/12 (0.00%) 
Investigations     
Platelet count decreased * 1  0/14 (0.00%)  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CAELYX Topotecan Hydrocloride (HCl)
Affected / at Risk (%) Affected / at Risk (%)
Total   12/14 (85.71%)   12/12 (100.00%) 
Blood and lymphatic system disorders     
Anemia * 1  5/14 (35.71%)  11/12 (91.67%) 
Leukopenia * 1  5/14 (35.71%)  2/12 (16.67%) 
Neutropenia * 1  5/14 (35.71%)  1/12 (8.33%) 
Thrombocytopenia * 1  1/14 (7.14%)  2/12 (16.67%) 
Neutrophilia * 1  1/14 (7.14%)  0/12 (0.00%) 
Gastrointestinal disorders     
Vomiting * 1  5/14 (35.71%)  8/12 (66.67%) 
Nausea * 1  6/14 (42.86%)  5/12 (41.67%) 
Constipation * 1  2/14 (14.29%)  1/12 (8.33%) 
Mouth ulceration * 1  3/14 (21.43%)  0/12 (0.00%) 
Stomatitis * 1  3/14 (21.43%)  0/12 (0.00%) 
Abdominal distension * 1  1/14 (7.14%)  1/12 (8.33%) 
Abdominal pain * 1  0/14 (0.00%)  2/12 (16.67%) 
Diarrhoea * 1  1/14 (7.14%)  1/12 (8.33%) 
Abdominal pain upper * 1  0/14 (0.00%)  1/12 (8.33%) 
Gastrointestinal pain * 1  0/14 (0.00%)  1/12 (8.33%) 
Ileus * 1  0/14 (0.00%)  1/12 (8.33%) 
General disorders     
Pyrexia * 1  1/14 (7.14%)  1/12 (8.33%) 
Fatigue * 1  0/14 (0.00%)  1/12 (8.33%) 
Irritability * 1  1/14 (7.14%)  0/12 (0.00%) 
Immune system disorders     
Anaphylactic reaction * 1  1/14 (7.14%)  0/12 (0.00%) 
Hypersensitivity * 1  0/14 (0.00%)  1/12 (8.33%) 
Infusion related reaction * 1  1/14 (7.14%)  0/12 (0.00%) 
Infections and infestations     
Upper respiratory tract infection * 1  2/14 (14.29%)  0/12 (0.00%) 
Folliculitis * 1  1/14 (7.14%)  0/12 (0.00%) 
Herpes zoster * 1  1/14 (7.14%)  0/12 (0.00%) 
Pulmonary tuberculosis * 1  1/14 (7.14%)  0/12 (0.00%) 
Vaginal infection * 1  1/14 (7.14%)  0/12 (0.00%) 
Investigations     
Leukocytosis * 1  1/14 (7.14%)  0/12 (0.00%) 
White blood cell count decreased * 1  6/14 (42.86%)  10/12 (83.33%) 
Neutrophil count decreased * 1  6/14 (42.86%)  9/12 (75.00%) 
Platelet count decreased * 1  0/14 (0.00%)  6/12 (50.00%) 
Alanine aminotransferase increased * 1  2/14 (14.29%)  1/12 (8.33%) 
Aspartate aminotransferase increased * 1  3/14 (21.43%)  0/12 (0.00%) 
Weight decreased * 1  1/14 (7.14%)  1/12 (8.33%) 
Blood albumin decreased * 1  1/14 (7.14%)  0/12 (0.00%) 
Lymphocyte percentage decreased * 1  0/14 (0.00%)  1/12 (8.33%) 
Platelet count increased * 1  0/14 (0.00%)  1/12 (8.33%) 
White blood cell count increased * 1  0/14 (0.00%)  1/12 (8.33%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  0/14 (0.00%)  1/12 (8.33%) 
Hyperglycaemia * 1  1/14 (7.14%)  0/12 (0.00%) 
Hypoalbuminaemia * 1  0/14 (0.00%)  1/12 (8.33%) 
Psychiatric disorders     
Insomnia * 1  0/14 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/14 (14.29%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome * 1  5/14 (35.71%)  0/12 (0.00%) 
Dermatitis * 1  1/14 (7.14%)  0/12 (0.00%) 
Dermatitis acneiform * 1  1/14 (7.14%)  0/12 (0.00%) 
Purpura * 1  1/14 (7.14%)  0/12 (0.00%) 
Rash * 1  1/14 (7.14%)  0/12 (0.00%) 
Rash maculo-papular * 1  1/14 (7.14%)  0/12 (0.00%) 
Skin hyperpigmentation * 1  1/14 (7.14%)  0/12 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0.
The study was terminated early as the total number of participants treated in this study was low and only descriptive analysis was used for efficacy and safety evaluation.
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clin Development
Organization: Xian Janssen Pharmaceutical LTD
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01840943     History of Changes
Other Study ID Numbers: CR100654
DOXILOVC3001 ( Other Identifier: Xian-Janssen Pharmaceutical Ltd., China )
First Submitted: March 18, 2013
First Posted: April 26, 2013
Results First Submitted: May 22, 2015
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015