CClinicalTrials.gg
Sign In
CompletedNCT01606748Updated Sep 30, 2019Results posted

A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin

A Phase 2 interventional study of Necitumumab and Gemcitabine in Malignant Solid Tumor, sponsored by Eli Lilly and Company. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the pharmacokinetics (PK) of necitumumab in combination with gemcitabine-cisplatin in participants with advanced malignant solid tumors and to assess the potential for drug-drug interactions between necitumumab and gemcitabine-cisplatin.

02

Conditions studied

  • Malignant Solid Tumor

Browse trials for

Keywords

  • Advanced Malignant Solid Tumors
  • Solid Cancers
  • Non-small Cell Lung Cancer
  • NSCLC
  • Breast Cancer
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 35 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse 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

  • Have documented advanced or metastatic malignant solid tumors (except for colorectal tumors with KRAS mutation) that are resistant to standard therapy or for which no standard therapy is available
  • May have measurable or non-measurable disease
  • Have resolution to Grade 0 or 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE 4.0) of all clinically significant toxic effects (other than alopecia) of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
  • Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
  • Have adequate hepatic, hematologic and renal function
  • If female, are surgically sterile, postmenopausal, or agree to be compliant with a highly effective contraceptive method during and for 6 months after the treatment period. If male, are surgically sterile or agree to be compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period
  • Female participants of childbearing potential have a negative serum pregnancy test within 7 days prior to the first dose of study therapy

Exclusion criteria

Exclusion Criteria:

  • Have received a systemic anticancer agent (including EGFR tyrosine kinase inhibitors) or device within 28 days prior to first dose of study therapy
  • The most recent anticancer therapy received by the participant included either gemcitabine or cisplatin (or both)
  • Have received radiotherapy within 14 days prior to first dose of study therapy
  • Have received cytotoxic chemotherapy within 21 days prior to first dose of study therapy
  • Are receiving concurrent treatment with another anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiation therapy, chemoembolization, or targeted therapy
  • Are considered surgical candidates (with resectable disease)
  • Have brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants
  • Have narrowing of or blockage in large veins
  • Have coronary artery disease or uncontrolled congestive heart failure
  • Have uncontrolled angina pectoris, or experienced myocardial infarction within 6 months prior to first dose of study therapy
  • Have an ongoing or active infection (requiring treatment), including active tuberculosis or known infection with the human immunodeficiency virus
  • Have a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder
  • Have known drug or alcohol abuse
  • If female, are pregnant or breastfeeding
  • Have had major surgery within 28 days prior to first dose of study medication or subcutaneous venous access device implantation within 7 days prior to first dose of study therapy
  • Are currently enrolled in, or discontinued within the 30 days prior to first dose of study therapy from a clinical trial involving an investigational product or nonapproved use of a drug or device, 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Necitumumab, Gemcitabine and Cisplatin

    The study will be conducted in two sequential periods: a 3-week PK run-in participants will be treated sequentially with single doses of cisplatin, gemcitabine, and necitumumab. Cycle 1 will begin immediately following the PK run-in period.

    Biological: Necitumumab · Drug: Gemcitabine · Drug: Cisplatin

Interventions

  • BiologicalNecitumumab

    PK Run-In Period: Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (I.V.) infusion at an absolute dose of 800 mg Treatment Cycles: Necitumumab administered on Days 1 and 8 of every 3-week cycle as an intravenous (I.V.) infusion at an absolute dose of 800 mg Participants in Cohort 1 will receive necitumumab Process C drug product and participants in Cohort 2 will receive necitumumab Process D drug product

    Also known as: IMC-11F8, LY3012211

  • DrugGemcitabine

    PK Run-In Period: Gemcitabine administered on Day 1 of the 3-week PK run-in period as an I.V. infusion at a dose of 1250 milligram per square meter (mg/m2) Treatment Cycles: Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an I.V. infusion at a dose of 1250 mg/m2

    Also known as: Gemzar®, LY188011

  • DrugCisplatin

    PK Run-In Period: Cisplatin administered on Day 1 of the 3-week PK run-in period as an I.V. infusion at a dose of 75 mg/m2 Treatment Cycles: Cisplatin administered on Day 1 of every 3-week cycle as an I.V. infusion at a dose of 75 mg/m2

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab

    Time frame: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

  2. PK: Dose-Normalized Cmax of Gemcitabine

    Time frame: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion

  3. PK: Dose-Normalized Cmax of Cisplatin

    Time frame: Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion

  4. PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab

    Time frame: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

  5. PK: Dose-Normalized AUC(0-24) of Gemcitabine

    Time frame: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion

  6. PK: Dose-Normalized AUC(0-5) of Cisplatin

    Time frame: Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion

  7. PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab

    Time frame: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1 Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

  8. PK: Dose Normalized AUC(0-∞) of Gemcitabine

    Time frame: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion

Secondary outcomes

  1. Number of Participants With Anti-Necitumumab Antibodies

    A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.

    Time frame: Baseline through, 30-Day Follow-Up

  2. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)

    ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.

    Time frame: Baseline to Measured Progressive Disease (Up to 14 Months)

  3. PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product

    Time frame: Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

  4. PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product

    Time frame: Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion

07

Results

Posted Aug 26, 2016

Participant flow

Participant flow — Overall Study
MilestoneNecitumumab Cohort 1Necitumumab Cohort 2
Started1817
Received at least 1 dose of study drug1817
Completed1517
Not completed30
Withdrew: Adverse event10
Withdrew: Progressive disease10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryPharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab
Time frame:
Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Reported as:
Geometric mean · microgram/milliliter (ug/mL)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab
microgram/milliliter (ug/mL)Necitumumab Cohort 1 Day 3 Run-inNecitumumab Cohort 1 Day 1, Cycle 1, Combination
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab277 ± 22315 ± 23
PrimaryPK: Dose-Normalized Cmax of Gemcitabine
Time frame:
Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion
Reported as:
Geometric mean · nanogram(ng)/mL/mg
PK: Dose-Normalized Cmax of Gemcitabine
nanogram(ng)/mL/mgGemcitabine Cohort 1 Day 1 PK Run-InGemcitabine Cohort 1 Day 1, Cycle 1, Combination
PK: Dose-Normalized Cmax of Gemcitabine4.83 ± 667.87 ± 43
PrimaryPK: Dose-Normalized Cmax of Cisplatin
Time frame:
Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion
Reported as:
Geometric mean · nanogram (ng)/mL/mg
PK: Dose-Normalized Cmax of Cisplatin
nanogram (ng)/mL/mgCisplatin Cohort 1 Day 1 Run-inCisplatin Cohort 1 Day 1, Cycle 1, Combination
PK: Dose-Normalized Cmax of Cisplatin19.2 ± 2122.1 ± 30
PrimaryPK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab
Time frame:
Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Reported as:
Geometric mean · ug*hour(h)/mL
PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab
ug*hour(h)/mLNecitumumab Cohort 1 Day 3 Run-InNecitumumab Cohort 1 Day 1, Cycle 1, Combination
PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab21900 ± 2422900 ± 34
SecondaryNumber of Participants With Anti-Necitumumab Antibodies

A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.

Time frame:
Baseline through, 30-Day Follow-Up
Reported as:
Number · participants with immunogenicity samples
Number of Participants With Anti-Necitumumab Antibodies
participants with immunogenicity samplesNecitumumab Cohort 1Necitumumab Cohort 2
ADA Positive30
TE Antibodies10
Neutralizing Antibodies00
SecondaryPercentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)

ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.

Time frame:
Baseline to Measured Progressive Disease (Up to 14 Months)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)
percentage of participantsNecitumumab Cohort 1Necitumumab Cohort 2
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)16.7 (3.6 to 41.4)5.9 (0.1 to 28.7)
SecondaryPK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product
Time frame:
Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Reported as:
Geometric mean · ug/mL
PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product
ug/mLNecitumumab Cohort 1Necitumumab Cohort 2
PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product277 ± 22300 ± 36
PrimaryPK: Dose-Normalized AUC(0-24) of Gemcitabine
Time frame:
Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion
Reported as:
Geometric mean · ng*h/mL/mg
PK: Dose-Normalized AUC(0-24) of Gemcitabine
ng*h/mL/mgGemcitabine Cohort 1 Day 1 PK Run-inGemcitabine Cohort 1 Day 1, Cycle 1, Combination
PK: Dose-Normalized AUC(0-24) of Gemcitabine2.71 ± 453.31 ± 33
SecondaryPK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product
Time frame:
Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Reported as:
Geometric mean · ug*h/mL
PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product
ug*h/mLNecitumumab Cohort 1Necitumumab Cohort 2
PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product33800 ± 3335500 ± 35
PrimaryPK: Dose-Normalized AUC(0-5) of Cisplatin
Time frame:
Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion
Reported as:
Geometric mean · ng*h/mL/mg
PK: Dose-Normalized AUC(0-5) of Cisplatin
ng*h/mL/mgCisplatin Cohort 1 Day 1 Run-inCisplatin Cohort 1 Day 1, Cycle 1, Combination
PK: Dose-Normalized AUC(0-5) of Cisplatin61.5 ± 2067.3 ± 24
PrimaryPK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab
Time frame:
Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1 Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
Reported as:
Geometric mean · ug*h/mL
PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab
ug*h/mLNecitumumab Cohort 1 Day 3 PK Run-InNecitumumab Cohort 1 Day 1, Cycle 1, Combination
PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab33800 ± 3326400 ± 30
PrimaryPK: Dose Normalized AUC(0-∞) of Gemcitabine
Time frame:
Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion
Reported as:
Geometric mean · ng*h/mL/mg
PK: Dose Normalized AUC(0-∞) of Gemcitabine
ng*h/mL/mgGemcitabine Cohort 1 Day 1 PK Run-inGemcitabine Cohort 1 Day 1, Cycle 1, Combination
PK: Dose Normalized AUC(0-∞) of Gemcitabine2.72 ± 453.32 ± 33

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Necitumumab Cohort 1—5/18 (27.8%)18/18 (100%)
Necitumumab Cohort 2—8/17 (47.1%)17/17 (100%)
Most frequent serious events
Showing 10 of 32
Most frequent serious events
EventNecitumumab Cohort 1Necitumumab Cohort 2
DehydrationMetabolism and nutrition disorders0/182/17
PancytopeniaBlood and lymphatic system disorders0/181/17
NauseaGastrointestinal disorders0/181/17
Small intestinal obstructionGastrointestinal disorders0/181/17
AstheniaGeneral disorders0/181/17
Urinary tract infection bacterialInfections and infestations0/181/17
FallInjury, poisoning and procedural complications0/181/17
Decreased appetiteMetabolism and nutrition disorders0/181/17
HypokalaemiaMetabolism and nutrition disorders0/181/17
HypomagnesaemiaMetabolism and nutrition disorders0/181/17
Most frequent other events
Showing 10 of 231
Most frequent other events
EventNecitumumab Cohort 1Necitumumab Cohort 2
FatigueGeneral disorders14/1813/17
AnaemiaBlood and lymphatic system disorders10/1813/17
HypomagnesaemiaMetabolism and nutrition disorders10/1812/17
NauseaGastrointestinal disorders12/1810/17
ThrombocytopeniaBlood and lymphatic system disorders11/186/17
Aspartate aminotransferase increasedInvestigations11/188/17
VomitingGastrointestinal disorders10/186/17
White blood cell count decreasedInvestigations10/187/17
NeutropeniaBlood and lymphatic system disorders8/189/17
HypoalbuminaemiaMetabolism and nutrition disorders4/189/17

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)Necitumumab Cohort 1Necitumumab Cohort 2Total
Mean55.3 ± 15.5458.2 ± 13.8456.7 ± 14.59
Sex: Female, Male
Sex: Female, Male(Participants)Necitumumab Cohort 1Necitumumab Cohort 2Total
Female111021
Male7714
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Necitumumab Cohort 1Necitumumab Cohort 2Total
Hispanic or Latino112
Not Hispanic or Latino171633
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Necitumumab Cohort 1Necitumumab Cohort 2Total
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American033
White171431
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Necitumumab Cohort 1Necitumumab Cohort 2Total
United States181735
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline(participants)Necitumumab Cohort 1Necitumumab Cohort 2Total
09716
191019
>=2000
Disease Characteristics - Tumor Type
Disease Characteristics - Tumor Type(participants)Necitumumab Cohort 1Necitumumab Cohort 2Total
Breast Carcinoma347
Ovarian Carcinoma213
Small Cell Lung Carcinoma213
Thymic Tumor202
Nonsmall Cell Lung Carcinoma202
Melanoma112
Head and Neck Carcinoma112
Endometrial Carcinoma112
Hepatobilliary Carcinoma101
Left Parotid101
Liver101
Granulosa Cell Tumor of the Ovary101
Mesothelioma011
Neuroendocrine Tumor011
Hepatocellular Carcinoma011
Esophageal Carcinoma011
Colorectal Carcinoma011
Sarcoma, soft tissue011
Adenocarcinoma of the Ampula of Vater011
Pancreatic Carcinoma011
Prior Anti-Cancer Therapy
Prior Anti-Cancer Therapy(participants)Necitumumab Cohort 1Necitumumab Cohort 2Total
Any Prior Radiotherapy131023
Any Prior (Adjuvant/Neoadjuvant) Systemic Therapy171633
08

Study locations

4 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.
    Scottsdale, Arizona 85258, United States
  • 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.
    Detroit, Michigan 48202, United States
  • 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.
    Las Vegas, Nevada 89169, United States
  • 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.
    Pittsburgh, Pennsylvania 15213, United States
09

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01606748
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
May 28, 2012
Start date
Aug 2012
Primary completion
Jun 2013
Completion
Jun 2016
Results posted
Aug 26, 2016
Last update
Sep 30, 2019

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 ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Eli Lilly and Company

Start the discussion