Solid TumorPhase 1NCT01682135

A Study in Participants With Advanced Solid Tumors

A Phase 1 study testing Ramucirumab in people with Solid Tumor, run by Eli Lilly and Company at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This trial is testing ramucirumab (LY3009806) administered to Chinese participants with advanced solid tumors that are resistant to standard therapy or for whom no standard therapy is available. The purpose of this study is to evaluate how safe ramucirumab is and whether it causes any side effects. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor
What is being tested?: Ramucirumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteChina
Study dates: Nov 2012to Mar 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chinese participants with histopathologically or cytologically diagnosed advanced solid tumor
Did not respond to standard therapy or no standard therapy is available
Measurable or nonmeasurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at study entry
Able to provide written informed consent
A life expectancy of >3 months

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Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1500 per cubic millimeter (mm^3); hemoglobin concentration ≥9 grams per deciliter (g/dL); and platelet count ≥100,000/mm^3
Adequate hepatic function, as defined by: Total bilirubin level ≤1.5 x the upper limit of normal (ULN) (in participants with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN with direct bilirubin ≤ 1.5 x ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (or ≤5 x ULN if the participant has liver metastases
Adequate renal function, as defined by: Serum creatinine level ≤1.5 x ULN; or calculated serum creatinine clearance (Cockcroft-Gault) ≥50 milliliters per minute (mL/min)
Urinary protein is 0 or 1+ on dipstick but no edema nor serum albumin < lower level of normal
Adequate coagulation function, as defined by: International normalized ratio (INR) ≤1.5, or prothrombin time (PT) ≤1.5 x ULN and activated partial thromboplastin time (aPTT) ≤1.5 x ULN (unless receiving anticoagulation therapy)
Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study treatment

Who cannot join

Had chemotherapy or therapeutic radiotherapy within 14 days (6 weeks for nitrosoureas or mitomycin C) before entering the study or the participant has ongoing side effects (≥ Grade 2) due to previously administered agents
Has obvious evidence of intratumor cavitation
Has undergone major surgery within 28 days before study entry or has had a central venous access device inserted within 7 days before study entry
Has a history of gastrointestinal perforation, postoperative bleeding complications, or wound complications from a surgical procedure
Has elective or planned surgery to be conducted during the trial
Has documented and/or symptomatic brain or leptomeningeal metastases

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Has uncontrolled ongoing illness, for example: thrombotic or hemorrhagic disorders; hemoptysis; ongoing infection requiring systemic antibiotic treatment; congestive heart failure, angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months; stroke, transient ischemic attack (TIA), or other grade 3-4 arterial thromboembolic event occurring within 6 months; uncontrolled hypertension (≥150/≥90 millimeters of mercury [mmHg]); cardiac arrhythmia that requires treatment or asymptomatic sustained ventricular tachycardia; peripheral neuropathy ≥Grade 2; human immunodeficiency virus (HIV) or active, uncontrolled hepatitis, liver cirrhosis at a level of Child-Pugh Class B (or worse), liver cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. (Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis)
Has a serious or nonhealing wound, ulcer, or bone fracture within 28 days before study entry
Has experienced any Grade 3 or 4 gastrointestinal bleeding within 3 months before study entry
Has a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess <6 months before randomization, or the participant has a history of poorly controlled or recurrent inflammatory bowel disease (including Crohn's disease or ulcerative colitis)
Has participated in a clinical study of a non-approved experimental agent or procedure within 4 weeks prior to study entry for small molecules, or 8 weeks before study entry for non-approved monoclonal antibodies
Has a known allergy to ramucirumab or its excipients, a monoclonal antibody (MAb), or any other therapeutic protein, such as fresh frozen plasma, human serum albumin (HSA), cytokines, or interleukins. If there is suspicion that the participant may have an allergy, the participant should be excluded
Is pregnant (confirmed by urine or serum pregnancy test) or lactating
Has known alcohol or drug dependency
Is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs)
Is not considered to be suitable for this study, in the opinion of the investigator

Trial locations and contacts

1 site in 1 country.

China1 site

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, 200032

Other trials in China

About this study

Official title: Phase I Study of Ramucirumab in Patients With Advanced Solid Tumors

Conditions: Solid Tumor
Being tested: Ramucirumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RamucirumabBiological
Also called IMC-1121B, LY3009806
Administered IV.

Study groups in NCT01682135
Study group	Role	What they receive
Ramucirumab	Experimental	Ramucirumab administered intravenously (IV) at escalating doses (6 milligrams per kilogram [mg/kg] up to 10 mg/kg) every 2-3 weeks for 6 weeks (1 Cycle). Treatment may continue until discontinuation criterion is met. Receives: Biological: Ramucirumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
A summary of AEs and SAEs considered by the investigator to be drug-related is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
Measured: Baseline through Study Completion (Up to 12 Weeks)
Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab
Measured: Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)
Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab
Measured: Cycle 2-5: Predose
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab
Cycle 1 analysis performed: Area Under the Concentration-Time Curve Zero to Infinity (AUC[0-∞]); Cycle 2 analysis performed: Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUC[τ,ss])
Measured: Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)

Secondary outcomes (5)

Duration of Response
Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.
Measured: Time Between Meeting Response Criteria and Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)
Duration of Stable Disease (SD)
Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.
Measured: Baseline to Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)
Time to Disease Progression
Time to progressive disease was measured from the start of study drug until progressive disease. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.
Measured: Baseline to Progressive Disease (Up to 10 Weeks)
Number of Participants With Anti-Ramucirumab Antibodies
A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive.
Measured: Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion
Number of Participants With Best Objective Response (BOR)
Participants achieved disease control if they had a BOR of CR, PR or SD. Progressive Disease (PD) and those participants which were Not Evaluable (NE) were also reported. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.
Measured: Baseline to Progressive Disease or Participant Stopped Study (Up to 10 Weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Mar 2015

First posted10 Sep 2012 (estimated)
Study startNov 2012
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01682135
Sponsor's protocol ID: 14139
Other IDs: I4T-CR-JVBU
Status last verified: Jul 2016
First submitted: 6 Sep 2012
Last updated: 26 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cao J, Ji D, Chen Z, Shen W, Wang J, Li B, Chi H, Long A, Gao L, Li J. Phase I Dose-Escalation Study of Ramucirumab in Chinese Patients with Advanced Solid Tumors. Oncologist. 2017 Jun;22(6):638-e56. doi: 10.1634/theoncologist.2017-0137. Epub 2017 May 2.
PubMed 28465370

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
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Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
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Study of SC-102 in Patients With Advanced Solid Tumors
Advanced Solid Cancers
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)
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All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study of Ramucirumab in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT01682135
Acronym / sponsor ID: 14139
Conditions: Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 10 Sep 2012 (estimated)
Results: Posted 26 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ramucirumab	Experimental	Biological: RamucirumabRamucirumab administered intravenously (IV) at escalating doses (6 milligrams per kilogram [mg/kg] up to 10 mg/kg) every 2-3 weeks for 6 weeks (1 Cycle). Treatment may continue until discontinuation criterion is met.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Chinese participants with histopathologically or cytologically diagnosed advanced solid tumor
Did not respond to standard therapy or no standard therapy is available
Measurable or nonmeasurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at study entry
Able to provide written informed consent

Key exclusion criteria (16 listed)

Had chemotherapy or therapeutic radiotherapy within 14 days (6 weeks for nitrosoureas or mitomycin C) before entering the study or the participant has ongoing side effects (≥ Grade 2) due to previously administered agents
Has obvious evidence of intratumor cavitation
Has undergone major surgery within 28 days before study entry or has had a central venous access device inserted within 7 days before study entry
Has a history of gastrointestinal perforation, postoperative bleeding complications, or wound complications from a surgical procedure
Has elective or planned surgery to be conducted during the trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RamucirumabAlso: IMC-1121B, LY3009806Administered IV.	Biological	Ramucirumab

Primary outcome

Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
Time frame: Baseline through Study Completion (Up to 12 Weeks)
A summary of AEs and SAEs considered by the investigator to be drug-related is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab
Time frame: Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)
Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab
Time frame: Cycle 2-5: Predose
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab
Time frame: Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)
Cycle 1 analysis performed: Area Under the Concentration-Time Curve Zero to Infinity (AUC[0-∞]); Cycle 2 analysis performed: Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUC[τ,ss])

5 secondary outcomes

Duration of Response
Time frame: Time Between Meeting Response Criteria and Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)
Duration of Stable Disease (SD)
Time frame: Baseline to Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)
Time to Disease Progression
Time frame: Baseline to Progressive Disease (Up to 10 Weeks)
Number of Participants With Anti-Ramucirumab Antibodies
Time frame: Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion
Number of Participants With Best Objective Response (BOR)
Time frame: Baseline to Progressive Disease or Participant Stopped Study (Up to 10 Weeks)

Results and safety

Results posted to the registry on 26 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 - 6 mg/kg/2w Ramucirumab	6	6
Cohort 2 - 10 mg/kg/3w Ramucirumab	10	10
Cohort 3 - 8 mg/kg/2w Ramucirumab	12	12

Primary outcome: Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)

Time frame: Baseline through Study Completion (Up to 12 Weeks). Number. Unit: Participants

Measure	Cohort 1: 6 mg/kg/2w Ramucirumab n = 6	Cohort 2: 10 mg/kg/3w Ramucirumab n = 10	Cohort 3: 8 mg/kg/2w Ramucirumab n = 12
Drug-Related Adverse Event	4	8	10
Serious Adverse Event	0	1	0

Population analysed: All enrolled participants who received at least one dose of study drug.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab

Time frame: Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only). Geometric mean (Geometric Coefficient of Variation). Unit: microgram/milliliter (µg/mL)

Measure	Cohort 1: 6 mg/kg/2w Ramucirumab n = 6	Cohort 2: 10 mg/kg/3w Ramucirumab n = 9	Cohort 3: 8 mg/kg/2w Ramucirumab n = 12
Cycle 1 (n = 6, 9, 12)	155 (13)	186 (22)	190 (39)
Cycle 2 (n = 1, 6, 8)	NA (NA)	219 (22)	239 (19)

Population analysed: All enrolled participants who received at least one dose of study drug and had evaluable Cmax pharmacokinetics (PK) data.

Primary outcome: Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab

Time frame: Cycle 2-5: Predose. Geometric mean (Geometric Coefficient of Variation). Unit: µg/mL

Measure	Cohort 1: 6 mg/kg/2w Ramucirumab n = 5	Cohort 2: 10 mg/kg/3w Ramucirumab n = 8	Cohort 3: 8 mg/kg/2w Ramucirumab n = 10
Cycle 2 (n = 5, 8, 10)	36.9 (35)	29.5 (90)	59.7 (26)
Cycle 3 (n = 1, 2, 5)	NA (NA)	NA (NA)	68.7 (28)
Cycle 4 (n = 1, 2, 4)	NA (NA)	NA (NA)	79.6 (26)
Cycle 5 (n = 0, 3, 4)	NA (NA)	56.5 (17)	92.5 (19)

Population analysed: All enrolled participants who received at least one dose of study drug and had evaluable Cmin PK data.

Primary outcome: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab

Measure	Cohort 1: 6 mg/kg/2w Ramucirumab n = 5	Cohort 2: 10 mg/kg/3w Ramucirumab n = 7	Cohort 3: 8 mg/kg/2w Ramucirumab n = 7
Cycle 1 AUC(0-∞) (n = 5, 7, 7)	870 (14)	1430 (31)	1350 (9)
Cycle 2 AUC(τ,ss) (n = 1, 6, 8)	NA (NA)	1630 (32)	1540 (16)

Population analysed: All enrolled participants who received at least one dose of study drug and had evaluable AUC(0-∞) for Cycle 1 and AUC(τ,ss) for Cycle 2 PK data.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 - 6mg/kg/2w Ramucirumab	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Cohort 2 - 10mg/kg/3w Ramucirumab	2 of 10 (20%)	10 of 10 (100%)	Not reported
Cohort 3 - 8mg/kg/2w Ramucirumab	1 of 12 (8.3%)	12 of 12 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28465370Cao J, Ji D, Chen Z, Shen W, Wang J, Li B, Chi H, Long A, Gao L, Li J. Phase I Dose-Escalation Study of Ramucirumab in Chinese Patients with Advanced Solid Tumors. Oncologist. 2017 Jun;22(6):638-e56. doi: 10.1634/theoncologist.2017-0137. Epub 2017 May 2.

Related trials for Solid Tumor

RecruitingPhase 1/2
A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
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RecruitingPhase 1
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RecruitingPhase 1/2
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RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)
Advanced Solid Tumors, Malignant Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ramucirumab in people with Solid Tumor, run by Eli Lilly and Company at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs) (time frame: Baseline through Study Completion (Up to 12 Weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01682135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.