Pancreatic CancerPhase 1NCT02005315
A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
A Phase 1 study testing Vantictumab, Nab-Paclitaxel and Gemcitabine in people with Pancreatic Cancer and Stage IV Pancreatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cancer, Stage IV Pancreatic Cancer
- What is being tested?
- Vantictumab, Nab-Paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2013to Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Signed Informed Consent Form
- Age ≥18 years
- Histologically documented Stage IV ductal adenocarcinoma of the pancreas
- Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
- ECOG performance status of 0 or 1
- Adequate hematologic and end-organ function
- Evaluable or measurable disease per RECIST v1.1
- For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception
Who cannot join
- Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer
- Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
- Known hypersensitivity to any component of study treatments
- Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Hospital Anschutz Cancer Pavillion
Aurora, Colorado, 80045
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine.
Read the detailed description
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up to approximately 34 patients may be enrolled into the study.
- Conditions
- Pancreatic Cancer, Stage IV Pancreatic Cancer
- Being tested
- Vantictumab, Nab-Paclitaxel, Gemcitabine
- Keywords
- Pancreatic Cancer, 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.
VantictumabDrug
Also called OMP-18R5
Administered intravenous (IV) infusion.
Nab-PaclitaxelDrug
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
GemcitabineDrug
Gemcitabine will be administered by intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Vanctictumab (OMP-18R5) | Experimental | Vantictumab will be administered by intravenous (IV) infusion. Receives: Drug: Vantictumab; Drug: Nab-Paclitaxel; Drug: Gemcitabine |
| Nab-Paclitaxel | Experimental | Nab-Paclitaxel will be administered by intravenous (IV) infusion. Receives: Drug: Vantictumab; Drug: Nab-Paclitaxel; Drug: Gemcitabine |
| Gemcitabine | Experimental | Gemcitabine will be administered by intravenous (IV) infusion. Receives: Drug: Vantictumab; Drug: Nab-Paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel
Measured: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)
Secondary outcomes (1)
Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer
Apparent half life, AUC, clearance, volume of distribution
Measured: Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Romnee Clark, MD, Principal investigator, Indiana University Institutional Review Board (IRB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005315
- Sponsor's protocol ID
- 18R5-003
- Status last verified
- Sep 2020
- First submitted
- 3 Dec 2013
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02005315
- Acronym / sponsor ID
- 18R5-003
- Conditions
- Pancreatic Cancer, Stage IV Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Stage IV Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine.
Detailed description
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up to approximately 34 patients may be enrolled into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vanctictumab (OMP-18R5) | Experimental | Drug: Vantictumab, Drug: Nab-Paclitaxel, Drug: GemcitabineVantictumab will be administered by intravenous (IV) infusion. |
| Nab-Paclitaxel | Experimental | Drug: Vantictumab, Drug: Nab-Paclitaxel, Drug: GemcitabineNab-Paclitaxel will be administered by intravenous (IV) infusion. |
| Gemcitabine | Experimental | Drug: Vantictumab, Drug: Nab-Paclitaxel, Drug: GemcitabineGemcitabine will be administered by intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent Form
- Age ≥18 years
- Histologically documented Stage IV ductal adenocarcinoma of the pancreas
- Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
- ECOG performance status of 0 or 1
Key exclusion criteria (4 listed)
- Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer
- Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
- Known hypersensitivity to any component of study treatments
- Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
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 |
|---|---|---|
| VantictumabAlso: OMP-18R5Administered intravenous (IV) infusion. | Drug | Gemcitabine, Nab-Paclitaxel, Vanctictumab (OMP-18R5) |
| Nab-PaclitaxelNab-Paclitaxel will be administered by intravenous (IV) infusion. | Drug | Gemcitabine, Nab-Paclitaxel, Vanctictumab (OMP-18R5) |
| GemcitabineGemcitabine will be administered by intravenous (IV) infusion. | Drug | Gemcitabine, Nab-Paclitaxel, Vanctictumab (OMP-18R5) |
Primary outcome
Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)
The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel
1 secondary outcome
Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer
Time frame: Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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.
Romnee Clark, MD principal investigator
Indiana University Institutional Review Board (IRB)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vantictumab, Nab-Paclitaxel and Gemcitabine in people with Pancreatic Cancer and Stage IV Pancreatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 5 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 8 inclusion and 4 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer (time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)). 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 9 Sep 2020.