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CompletedNCT01005680Updated Dec 13, 2013Results posted

A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer

A Phase 3 interventional study of Pemetrexed and Gemcitabine in Non Small Cell Lung Cancer, sponsored by Eli Lilly and Company. Completed at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-13.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy and safety of two different chemotherapy types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).

02

Conditions studied

  • Non Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 256 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Present with histologically proven or cytological diagnosis of non-squamous non-small cell lung cancer (NSCLC) Stage IIIB or IV.
  • Participants must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
  • Female participants must not be pregnant.
  • No prior systemic chemotherapy for lung cancer.
  • At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors.
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
  • Adequate organ function.
  • Prior radiation therapy allowed to \<25% of the bone marrow.
  • Signed informed consent document on file.
  • Estimated life expectancy of greater than or equal to 12 weeks.
  • Participant compliance and geographic proximity that allow adequate follow up.

Exclusion criteria

Exclusion Criteria:

  • Peripheral neuropathy of great than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
  • Inability to comply with protocol or study procedures.
  • A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to complete the study.
  • A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
  • Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
  • Documented brain metastases unless the participant has completed successful local therapy for central nervous system metastases and has not taken corticosteroids for at least 4 weeks before enrollment.
  • Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
  • Significant weight loss (that is, greater than or equal to 10%) over the previous 6 weeks before study entry.
  • Concurrent administration of any other anti-tumor therapy.
  • Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents, such as piroxicam).
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation.
  • Inability to take corticosteroids.
  • Pregnant or breast-feeding.
  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
256 participants (actual)

Study arms

  • Experimental
    Pemetrexed plus Cisplatin

    Drug: Pemetrexed · Drug: Cisplatin

  • Active comparator
    Gemcitabine plus Cisplatin

    Drug: Gemcitabine · Drug: Cisplatin

Interventions

  • DrugPemetrexed

    500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles

    Also known as: Alimta, LY231514

  • DrugGemcitabine

    1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles

    Also known as: Gemzar, LY188011

  • DrugCisplatin

    75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.

    Time frame: Randomization to date of death from any cause up to 35.8 months post-randomization

Secondary outcomes

  1. Progression Free Survival (PFS)

    PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact.

    Time frame: Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization

  2. Time to Progressive Disease (TtPD)

    TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment.

    Time frame: Randomization to first date of PD up to 23.7 months post-randomization

  3. Duration of Response (DoR)

    DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions

    Time frame: Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization

  4. Time to Treatment Failure (TtTF)

    TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date.

    Time frame: Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization

  5. Tumor Response Rate

    Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions.

    Time frame: Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization

  6. Risk/Benefit Ratio

    Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year.

    Time frame: Randomization to date of death from any cause up to 35.8 months post-randomization

Other outcomes

  1. Disease Control Rate (DCR)

    DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria.

    Time frame: Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization

  2. Survival Without Toxicity (SWT)

    SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact.

    Time frame: Randomization to date of toxicity or date of death up to 34.6 months post-randomization

07

Results

Posted Dec 13, 2013

Participant flow

Participant flow — Overall Study
MilestonePemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Started126130
Received at least 1 dose of study drug125127
Completed120119
Not completed611
Withdrew: Lost to follow-up46
Withdrew: Withdrawal by subject14
Withdrew: Physician decision11

Outcome measures

PrimaryOverall Survival (OS)

OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.

Time frame:
Randomization to date of death from any cause up to 35.8 months post-randomization
Reported as:
Median · months
Overall Survival (OS)
monthsPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Overall Survival (OS)17.54 (13.34 to 22.67)15.51 (13.70 to 19.29)
Statistical analysis
  • Pemetrexed Plus Cisplatin (PC) vs Gemcitabine Plus Cisplatin (GC) · Cox Proportional Hazard · p = 0.822 (HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex, and basis for initial pathological diagnosis.) · Hazard ratio (hr): 1.03 · 95% CI 0.77 to 1.39
SecondaryProgression Free Survival (PFS)

PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact.

Time frame:
Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization
Reported as:
Median · months
Progression Free Survival (PFS)
monthsPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Progression Free Survival (PFS)5.88 (4.99 to 6.47)5.85 (5.59 to 6.41)
Statistical analysis
  • Pemetrexed Plus Cisplatin (PC) vs Gemcitabine Plus Cisplatin (GC) · Cox Proportional Hazard · p = 0.640 (HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.) · Hazard ratio (hr): 1.06 · 95% CI 0.82 to 1.37
SecondaryTime to Progressive Disease (TtPD)

TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment.

Time frame:
Randomization to first date of PD up to 23.7 months post-randomization
Reported as:
Median · months
Time to Progressive Disease (TtPD)
monthsPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Time to Progressive Disease (TtPD)5.82 (4.76 to 6.47)5.82 (5.55 to 6.34)
Statistical analysis
  • Pemetrexed Plus Cisplatin (PC) vs Gemcitabine Plus Cisplatin (GC) · Cox Proportional Hazard · p = 0.928 (HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and biases for initial pathological diagnosis.) · Hazard ratio (hr): 1.01 · 95% CI 0.78 to 1.32
SecondaryDuration of Response (DoR)

DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions

Time frame:
Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization
Reported as:
Median · months
Duration of Response (DoR)
monthsPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Duration of Response (DoR)4.53 (4.17 to 5.88)4.98 (3.55 to 6.41)
Statistical analysis
  • Pemetrexed Plus Cisplatin (PC) vs Gemcitabine Plus Cisplatin (GC) · Cox Proportional Hazard · p = 0.887 (HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.) · Hazard ratio (hr): 0.96 · 95% CI 0.51 to 1.79
SecondaryTime to Treatment Failure (TtTF)

TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date.

Time frame:
Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization
Reported as:
Median · months
Time to Treatment Failure (TtTF)
monthsPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Time to Treatment Failure (TtTF)NA (NA to NA)NA (NA to NA)
Statistical analysis
  • Pemetrexed Plus Cisplatin (PC) vs Gemcitabine Plus Cisplatin (GC) · Cox Proportional Hazard · p = 0.861 (HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.) · Hazard ratio (hr): 1.04 · 95% CI 0.67 to 1.61
SecondaryTumor Response Rate

Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions.

Time frame:
Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization
Reported as:
Number · percentage of participants
Tumor Response Rate
percentage of participantsPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Tumor Response Rate24.820.7
Statistical analysis
  • Pemetrexed Plus Cisplatin (PC) vs Gemcitabine Plus Cisplatin (GC) · two-sided Z test · p = 0.451
SecondaryRisk/Benefit Ratio

Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year.

Time frame:
Randomization to date of death from any cause up to 35.8 months post-randomization
Reported as:
Number · ratio
Risk/Benefit Ratio
ratioPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Risk/Benefit Ratio0.700.83
Other pre-specifiedDisease Control Rate (DCR)

DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria.

Time frame:
Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization
Reported as:
Number · percentage of participants
Disease Control Rate (DCR)
percentage of participantsPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Disease Control Rate (DCR)78.575.9
Statistical analysis
  • Pemetrexed Plus Cisplatin (PC) vs Gemcitabine Plus Cisplatin (GC) · two-sided Z test · p = 0.627
Other pre-specifiedSurvival Without Toxicity (SWT)

SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact.

Time frame:
Randomization to date of toxicity or date of death up to 34.6 months post-randomization
Reported as:
Median · months
Survival Without Toxicity (SWT)
monthsPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Survival Without Toxicity (SWT)5.85 (4.21 to 8.38)2.56 (1.68 to 3.78)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pemetrexed Plus Cisplatin (PC)—8/125 (6.4%)120/125 (96%)
Gemcitabine Plus Cisplatin (GC)—9/127 (7.1%)123/127 (96.9%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
Lung infectionInfections and infestations2/1250/127
Venous thrombosis limbVascular disorders2/1250/127
Bone marrow failureBlood and lymphatic system disorders0/1252/127
FatigueGeneral disorders1/1250/127
PyrexiaGeneral disorders1/1250/127
Neutrophil count decreasedInvestigations1/1250/127
HyponatraemiaMetabolism and nutrition disorders1/1250/127
DyspnoeaRespiratory, thoracic and mediastinal disorders1/1251/127
Pleural effusionRespiratory, thoracic and mediastinal disorders1/1250/127
Pulmonary embolismRespiratory, thoracic and mediastinal disorders1/1251/127
Most frequent other events
Showing 10 of 28
Most frequent other events
EventPemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)
NeutropeniaBlood and lymphatic system disorders52/12565/127
LeukopeniaBlood and lymphatic system disorders53/12560/127
NauseaGastrointestinal disorders56/12559/127
VomitingGastrointestinal disorders44/12554/127
Decreased appetiteMetabolism and nutrition disorders46/12539/127
AnaemiaBlood and lymphatic system disorders28/12544/127
FatigueGeneral disorders33/12533/127
Haemoglobin decreasedInvestigations21/12533/127
ConstipationGastrointestinal disorders21/12532/127
White blood cell count decreasedInvestigations25/12532/127

Baseline characteristics

All randomized participants.

Age Continuous
Age Continuous(years)Pemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)Total
Mean56.6 ± 10.6555.7 ± 9.9556.1 ± 10.29
Sex: Female, Male
Sex: Female, Male(Participants)Pemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)Total
Female5559114
Male7171142
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Pemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)Total
Hispanic or Latino000
Not Hispanic or Latino126130256
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)Total
American Indian or Alaska Native000
Asian126130256
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Pemetrexed Plus Cisplatin (PC)Gemcitabine Plus Cisplatin (GC)Total
China126130256
08

Study locations

8 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Beijing, 100730, China
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Changchun, 130012, China
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Dalian, 116023, China
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Guang Zhou, 510080, China
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Nanjing, 210002, China
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Nanning, 530000, China
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Shanghai, 200433, China
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Sichuan, 610041, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01005680
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 1, 2009
Start date
Nov 2009
Primary completion
Nov 2012
Completion
Nov 2012
Results posted
Dec 13, 2013
Last update
Dec 13, 2013

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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