Stage IV Pancreatic CancerPhase 1/2ALPINENCT01647828

A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer

A Phase 1/2 study testing OMP-59R5, Gemcitabine and Nab-Paclitaxel in people with Stage IV Pancreatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 26 sites in United States.

Completed

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

Official record

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Trial summary

The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with nab-paclitaxel and… Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Stage IV Pancreatic Cancer
What is being tested?: OMP-59R5, Gemcitabine and Nab-Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 217 participants
Where: 26 sitesUnited States
Study dates: Oct 2012to Apr 2016
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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must meet all of the following major inclusion criteria to be eligible for the study:
18 years of age or older
Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.
Performance Status (ECOG) 0 or 1
FFPE tumor tissue from metastatic site(s
Adequate organ function

Show all 9Show fewer

Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation.
For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration.
Male subjects must be surgically sterile or must agree to use physician-approved contraception from 30 days prior to the first study drug administration to 30 days following the last study drug administration.

Who cannot join

Subjects who meet any of the following major exclusion criteria will not be eligible for participation in the study:
Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.
Known brain metastases.
Prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage IV pancreatic cancer.
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
Any disorder that would significantly compromise protocol compliance.

Show all 9Show fewer

Prior non-pancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery and/or radiotherapy alone must be in remission ≥3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
Known human immunodeficiency virus (HIV) infection.
Females who are pregnant or breastfeeding.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

University of Michigan Health System
Ann Arbor, Michigan, 48109
Northside Hospital, Inc. - GCS/Almex
Atlanta, Georgia, 30341
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Bend Memorial Clinic
Bend, Oregon, 97701
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
Cleveland Clinic
Cleveland, Ohio, 44195
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Duke University Medical Center
Durham, North Carolina, 27710
St Jude Heritage Healthcare Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Western Regional Medical Center, Inc.
Goodyear, Arizona, 85338
Greenville Health System, Clinical Research Unit, Institute for Translational Oncology Research
Greenville, South Carolina, 29605
Comprehensive Cancer Centers ofNevada
Las Vegas, Nevada, 89128
Pacific Shores Medical Group
Long Beach, California, 90813
Ronald Reagan UCLA Medical Center, Drug Information Center, Department of Pharmaceutical Services
Los Angeles, California, 90095
University of Wiscons in Hospi tal and Clinics
Madison, Wisconsin, 53792
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 533226
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Orlando Health, Inc.
Orlando, Florida, 32806
Torrance Health Association Dba Torrance Memorial Physician Network/Cancer Care Associates
Redondo Beach, California, 90277
South Texas Accelerated Research Thereapeutics, LLC (START)
San Antonio, Texas, 78229
Virginia Mason Medical Center
Seattle, Washington, 98101
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer

Conditions: Stage IV Pancreatic Cancer
Being tested: OMP-59R5, Gemcitabine, Placebo, Nab-Paclitaxel
Keywords: Newly diagnosed Stage IV Pancreatic Cancer
Medical subject headings: Pancreatic Neoplasms

What participants receive

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

OMP-59R5Drug
OMP-59R5 administered intravenously
GemcitabineDrug
administered intravenously
PlaceboDrug
administered IV
Nab-PaclitaxelDrug
Also called Abraxane
administered intravenously

Study groups in NCT01647828
Study group	Role	What they receive
OMP-59R5 plus Gemcitabine and Nab-Paclitaxel	Experimental	OMP-59R5 plus Gemcitabine and Nab-Paclitaxel Receives: Drug: OMP-59R5; Drug: Gemcitabine; Drug: Nab-Paclitaxel
Gemcitabine and Nab-Paclitaxel plus Placebo	Experimental	Gemcitabine and Nab-Paclitaxel plus Placebo Receives: Drug: Gemcitabine; Drug: Placebo; Drug: Nab-Paclitaxel

What is being measured

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

Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)
Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD).
Measured: Up to 1 year in absence of unacceptable toxicity or disease progression.
Phase 2: Overall Survival (ITT Population)
To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer.
Measured: Up to 1 year in absence of unacceptable toxicity or disease progression.
Phase 2: Median OS by Notch 3 Percentile (ITT Population)
To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level.
Measured: Up to 1 year in absence of unacceptable toxicity or disease progression.

Timeline

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

Oct 2012Apr 2016

First posted24 Jul 2012 (estimated)
Study startOct 2012
Primary completionApr 2016
Study completionApr 2016

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 Stage IV Pancreatic CancerStudies of the same condition, open and under way.
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: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01647828
Sponsor's protocol ID: 59R5-002
Acronym: ALPINE
Status last verified: Jan 2023
First submitted: 11 Jul 2012
Last updated: 15 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hu ZI, Bendell JC, Bullock A, LoConte NK, Hatoum H, Ritch P, Hool H, Leach JW, Sanchez J, Sohal DPS, Strickler J, Patel R, Wang-Gillam A, Firdaus I, Yu KH, Kapoun AM, Holmgren E, Zhou L, Dupont J, Picozzi V, Sahai V, O'Reilly EM. A randomized phase II trial of nab-paclitaxel and gemcitabine with tarextumab or placebo in patients with untreated metastatic pancreatic cancer. Cancer Med. 2019 Sep;8(11):5148-5157. doi: 10.1002/cam4.2425. Epub 2019 Jul 26.
PubMed 31347292

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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Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
ClinicalTrials.gov ID: NCT01647828
Acronym / sponsor ID: ALPINE / 59R5-002
Conditions: Stage IV Pancreatic Cancer
Keywords: Newly diagnosed Stage IV Pancreatic Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 24 Jul 2012 (estimated)
Results: Posted 15 Feb 2023

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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
OMP-59R5 plus Gemcitabine and Nab-Paclitaxel	Experimental	Drug: OMP-59R5, Drug: Gemcitabine, Drug: Nab-PaclitaxelOMP-59R5 plus Gemcitabine and Nab-Paclitaxel
Gemcitabine and Nab-Paclitaxel plus Placebo	Experimental	Drug: Gemcitabine, Drug: Placebo, Drug: Nab-PaclitaxelGemcitabine and Nab-Paclitaxel plus Placebo

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Subjects must meet all of the following major inclusion criteria to be eligible for the study:
18 years of age or older
Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.
Performance Status (ECOG) 0 or 1
FFPE tumor tissue from metastatic site(s

Key exclusion criteria (9 listed)

Subjects who meet any of the following major exclusion criteria will not be eligible for participation in the study:
Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.
Known brain metastases.
Prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage IV pancreatic cancer.
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).

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
OMP-59R5OMP-59R5 administered intravenously	Drug	OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
Gemcitabineadministered intravenously	Drug	Gemcitabine and Nab-Paclitaxel plus Placebo, OMP-59R5 plus Gemcitabine and Nab-Paclitaxel
Placeboadministered IV	Drug	Gemcitabine and Nab-Paclitaxel plus Placebo
Nab-PaclitaxelAlso: Abraxaneadministered intravenously	Drug	Gemcitabine and Nab-Paclitaxel plus Placebo, OMP-59R5 plus Gemcitabine and Nab-Paclitaxel

Primary outcome

Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)
Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.
Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD).
Phase 2: Overall Survival (ITT Population)
Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.
To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer.
Phase 2: Median OS by Notch 3 Percentile (ITT Population)
Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.
To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level.

Results and safety

Results posted to the registry on 15 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
P1B: OMP-59R5 2.5 mg/kg + Gem	5	0
P1B: OMP-59R5 5 mg/kg + Gem	4	0
P1B: OMP-59R5 5 mg/kg + Nab-P + Gem	4	0
P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem	6	0
P1B: OMP-59R5 10 mg/kg + Nab-P + Gem	6	0
P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem	3	0
P1B: OMP-59R5 15 mg/kg + Nab-P + Gem	12	0
P2: Placebo + Nab-P + Gem	88	0
P2: OMP-59R5 15 mg/kg + Nab-P + Gem	89	0

Primary outcome: Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)

Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.. Count of participants. Unit: Participants

Measure	P1B: OMP-59R5 2.5 mg/kg + Gem n = 4	P1B: OMP-59R5 5 mg/kg + Gem n = 4	P1B: OMP-59R5 5 mg/kg + Nab-P + Gem n = 4	P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem n = 6	P1B: OMP-59R5 10 mg/kg + Nab-P + Gem n = 6	P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem n = 3	P1B: OMP-59R5 15 mg/kg + Nab-P + Gem n = 10
Value	0	0	0	0	0	0	1

Population analysed: The DLT Evaluable Population comprised all participants who received at least 1 partial dose of tarextumab during the Phase 1b dose escalation portion of the study (enrolled before the MTD was determined) and who completed Day 15 of Cycle 1 tarextumab administration or discontinued due to drug-related toxicity.

Primary outcome: Phase 2: Overall Survival (ITT Population)

Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.. Number. Unit: participants

Measure	P2: Placebo + Nab-P + Gem n = 88	P2: OMP-59R5 15 mg/kg + Nab-P + Gem n = 89
Number of subjects who died	60	71
Number of subjects who did not die	28	18

Primary outcome: Phase 2: Median OS by Notch 3 Percentile (ITT Population)

Time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.. Median (95% Confidence Interval). Unit: Days

Measure	P2: Placebo + Nab-P + Gem n = 55	P2: OMP-59R5 15 mg/kg + Nab-P + Gem n = 55
Notch 3 ≥ 75th percentile	187.5 (95.0 to NA)	228.0 (101.0 to 453.0)
Notch 3 ≥ 50th percentile	220.5 (135.0 to 329.0)	151.0 (101.0 to 258.0)
Notch 3 ≥ 25th percentile	206.0 (146.0 to 312.0)	165.0 (123.0 to 252.0)

Population analysed: The Intent-to-Treat (ITT) Population comprised all participants who received at least 1 partial dose of tarextumab. Here, Overall Number of Participants Analyzed = number of participants with Notch 3 ≥ 25th percentile, and Number Analyzed = number of participants in each Notch 3 percentile subset.

Adverse events

Time frame: From date of first dose to date of last dose plus 30 days (up to approximately 17 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P1B: OMP-59R5 2.5 mg/kg + Gem	4 of 5 (80%)	5 of 5 (100%)	3 of 5
P1B: OMP-59R5 5 mg/kg + Gem	1 of 4 (25%)	4 of 4 (100%)	4 of 4
P1B: OMP-59R5 5 mg/kg + Nab-P + Gem	1 of 4 (25%)	4 of 4 (100%)	4 of 4
P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem	3 of 6 (50%)	6 of 6 (100%)	5 of 6
P1B: OMP-59R5 10 mg/kg + Nab-P + Gem	4 of 6 (66.7%)	6 of 6 (100%)	6 of 6
P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
P1B: OMP-59R5 15 mg/kg + Nab-P + Gem	9 of 12 (75%)	12 of 12 (100%)	10 of 12
P2: Placebo + Nab-P + Gem	51 of 85 (60%)	85 of 85 (100%)	60 of 88
P2: OMP-59R5 15 mg/kg + Nab-P + Gem	58 of 87 (66.7%)	87 of 87 (100%)	71 of 89

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31347292Hu ZI, Bendell JC, Bullock A, LoConte NK, Hatoum H, Ritch P, Hool H, Leach JW, Sanchez J, Sohal DPS, Strickler J, Patel R, Wang-Gillam A, Firdaus I, Yu KH, Kapoun AM, Holmgren E, Zhou L, Dupont J, Picozzi V, Sahai V, O'Reilly EM. A randomized phase II trial of nab-paclitaxel and gemcitabine with tarextumab or placebo in patients with untreated metastatic pancreatic cancer. Cancer Med. 2019 Sep;8(11):5148-5157. doi: 10.1002/cam4.2425. Epub 2019 Jul 26.

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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.

Eileen M O'Reilly, MD principal investigator

Memorial Sloan Kettering Cancer Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OMP-59R5, Gemcitabine and Nab-Paclitaxel in people with Stage IV Pancreatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 26 sites in United States.

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 9 inclusion and 9 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. 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 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 15 Feb 2023). 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 Ib: Number of Participants With Dose-limiting Toxicities (DLT) (time frame: Up to 1 year in absence of unacceptable toxicity or disease progression.). The study lists 3 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 NCT01647828, 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 15 Feb 2023.