Metastatic Pancreatic CancerPhase 1/2NCT03086369
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
A Phase 1/2 study testing Olaratumab, Nab-paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Eli Lilly and Company at 34 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Olaratumab, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 22 Jun 2017to 17 Jun 2021
- Phase
- Phase 1/2
- 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
- Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.
- If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
- Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.
- Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.
- Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
- Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Discontinued all previous treatments for cancer ≥4 weeks prior.
- Adequate organ function.
- Life expectancy of at least 3 months.
Who cannot join
- Serious concomitant systemic disorder.
- Have received first line treatment for metastatic pancreatic cancer.
- Received prior treatment with nab-paclitaxel.
- Have known central nervous system malignancy or metastasis.
- Current hematologic malignancies.
- Participated within the last 30 days in a clinical trial involving an investigational product.
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- Women with a positive pregnancy test or lactating.
- Have endocrine pancreatic tumors or ampullary cancer.
- Currently enrolled in another clinical trial.
- Have a known additional malignancy that is progressing or required active treatment within the past 1 year.
- Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.
- Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
United States32 sites
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Roswell Park Cancer Institute
Buffalo, New York, 14263-0002
Medical University of South Carolina
Charleston, South Carolina, 29425
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Florida Cancer Specialists
Fort Myers, Florida, 33901
Fort Wayne Oncology & Hematology
Fort Wayne, Indiana, 46845
St Jude Medical Center
Fullerton, California, 92835
Monter Cancer Center
Lake Success, New York, 11042
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, 90024
UCLA Medical Center
Los Angeles, California, 90095
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, 53792-4108
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232-1305
University of Utah School of Medicine
Salt Lake City, Utah, 84112
Univ of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Cancer Center of Santa Barbara with Sansum Clinic
Santa Barbara, California, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258
Sanford Research/USD
Sioux Falls, South Dakota, 57104
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705
H Lee Moffitt Cancer Center
Tampa, Florida, 33612-9497
University of Arizona Cancer Center
Tucson, Arizona, 85724
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Olaratumab, Nab-paclitaxel, Gemcitabine, Placebo
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaratumabDrug
Also called LY3012207
Administered IV
Nab-paclitaxelDrug
Administered IV
GemcitabineDrug
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Experimental | Participants received intravenous (IV) infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. Receives: Drug: Olaratumab; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Experimental | Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. Receives: Drug: Olaratumab; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Experimental | Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. Receives: Drug: Olaratumab; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Experimental | Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. Receives: Drug: Olaratumab; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | Placebo comparator | Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03:
- Any febrile neutropenia
- Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage
- Grade 4 neutropenia lasting 7 days or longer
- Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc.
- Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).
Measured: Cycle 1 (Up to 28 days)
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Measured: Baseline to Date of Death from Any Cause (Up To 29 Months)
Secondary outcomes (9)
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
PK: Cmin of olaratumab
Measured: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Measured: Baseline through Follow-up (Up To 29 Months)
Phase 1b: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Measured: Baseline to Date of Death from Any Cause (Approximately 9 Months)
Phase 2: Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.
Measured: Baseline to Disease Progression or Death (Up To 26 Months)
Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Measured: Baseline through Disease Progression or Death (Up To 26 Months)
Phase 1b/2: Duration of Response (DoR)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.
Measured: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
Measured: Baseline through Follow-up (Up To 21 Months)
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
Measured: Baseline through Follow-up (Up To 21 Months)
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
Measured: Cycle 1 Day 1, Cycle 7 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start22 Jun 2017
- Primary completion5 Jan 2021
- Study completion17 Jun 2021
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.
- Other trials for Metastatic Pancreatic CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086369
- Sponsor's protocol ID
- 15844
- Other IDs
- I5B-MC-JGDP, 2016-001099-31, 2016
- Status last verified
- Jun 2022
- First submitted
- 13 Mar 2017
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03086369
- Acronym / sponsor ID
- 15844
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Experimental | Drug: Olaratumab, Drug: Nab-paclitaxel, Drug: GemcitabineParticipants received intravenous (IV) infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. |
| Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Experimental | Drug: Olaratumab, Drug: Nab-paclitaxel, Drug: GemcitabineParticipants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. |
| Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Experimental | Drug: Olaratumab, Drug: Nab-paclitaxel, Drug: GemcitabineFollowing a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. |
| Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Experimental | Drug: Olaratumab, Drug: Nab-paclitaxel, Drug: GemcitabineParticipants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. |
| Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | Placebo comparator | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: PlaceboParticipants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.
- If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
- Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.
- Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.
- Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
Key exclusion criteria (12 listed)
- Serious concomitant systemic disorder.
- Have received first line treatment for metastatic pancreatic cancer.
- Received prior treatment with nab-paclitaxel.
- Have known central nervous system malignancy or metastasis.
- Current hematologic malignancies.
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 |
|---|---|---|
| OlaratumabAlso: LY3012207Administered IV | Drug | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine, Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine, Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine, Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine |
| Nab-paclitaxelAdministered IV | Drug | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine, Phase 2: Placebo + Nab-paclitaxel + Gemcitabine, Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine, Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine, Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine |
| GemcitabineAdministered IV | Drug | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine, Phase 2: Placebo + Nab-paclitaxel + Gemcitabine, Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine, Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine, Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine |
| PlaceboAdministered IV | Drug | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
Primary outcome
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (Up to 28 days)
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03: 1. Any febrile neutropenia 2. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage 3. Grade 4 neutropenia lasting 7 days or longer 4. Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc. 5. Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).
Phase 2: Overall Survival (OS)
Time frame: Baseline to Date of Death from Any Cause (Up To 29 Months)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
9 secondary outcomes
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
Time frame: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Time frame: Baseline through Follow-up (Up To 29 Months)
Phase 1b: Overall Survival (OS)
Time frame: Baseline to Date of Death from Any Cause (Approximately 9 Months)
Phase 2: Progression-Free Survival (PFS)
Time frame: Baseline to Disease Progression or Death (Up To 26 Months)
Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Time frame: Baseline through Disease Progression or Death (Up To 26 Months)
Phase 1b/2: Duration of Response (DoR)
Time frame: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
Time frame: Baseline through Follow-up (Up To 21 Months)
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
Time frame: Baseline through Follow-up (Up To 21 Months)
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
Time frame: Cycle 1 Day 1, Cycle 7 Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic CancerLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Olaratumab, Nab-paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Eli Lilly and Company at 34 sites in 3 countries.
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 10 inclusion and 12 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Germany, Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 Jan 2022). 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?
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (Up to 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2022.