Relapsed/Refractory Metastatic Pancreatic Ductal AdenocarcinomaPhase 1NCT02244489
Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1 study testing Momelotinib (MMB), Capecitabine and Oxaliplatin in people with Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma, run by Sierra Oncology LLC - a GSK company at 4 sites in United States.
Trial summary
This study will evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Momelotinib (MMB), Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Nov 2014to 5 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory metastatic pancreatic adenocarcinoma
- Received 1 prior chemotherapy regimen for metastatic pancreatic ductal adenocarcinoma (not including neoadjuvant and/or adjuvant therapy)
- Measurable disease per RECIST v1.1
- Adequate organ function defined as
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN) OR ≤ 5 x ULN if liver metastases are present; total conjugated bilirubin ≤ 2 x ULN
- Absolute neutrophil count (ANC) ≥1500 cells/mm^3, platelet ≥100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dL
- Creatinine clearance (CrCl) > 50 ml/min as calculated by the Cockroft-Gault method
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Who cannot join
- Received more than 1 prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma
- Major surgery within 21 days of first dose of study drug
- Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable)
- Chemotherapy, immunotherapy, biologics, and/or investigational therapy within 21 days prior to first dose of study drug
- Known positive status for HIV, chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier
- Known dihydropyrimidine dehydrogenase deficiency
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- Peripheral neuropathy ≥ Grade 2
- Any condition that impairs gastrointestinal absorption of drug
- Known or suspected brain or central nervous system metastases
- Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma
- External biliary drain
- Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Tennessee Oncology
Nashville, Tennessee, 37203
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1b Study Evaluating Momelotinib Combined With Capecitabine and Oxaliplatin in Subjects With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
This study will evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma.
- Being tested
- Momelotinib (MMB), Capecitabine, Oxaliplatin
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Momelotinib (MMB)Drug
Also called GS-0387, CYT387
Momelotinib (MMB) tablet(s) administered orally once or twice daily
CapecitabineDrug
Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment
OxaliplatinDrug
Oxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Momelotinib (MMB)+capecitabine | Experimental | Participants will receive momelotinib (MMB)+capecitabine at varying dose levels to determine the MTD for momelotinib (MMB) and capecitabine. Receives: Drug: Momelotinib (MMB); Drug: Capecitabine |
| Momelotinib (MMB)+capecitabine+oxaliplatin | Experimental | Upon reaching the MTD for momelotinib (MMB) and capecitabine or if no MTD is reached, participants will receive momelotinib (MMB)+capecitabine at the MTD plus oxaliplatin at varying dose levels to determine the MTD of combination capecitabine, momelotinib (MMB), and oxaliplatin. Receives: Drug: Momelotinib (MMB); Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities
Dose limiting toxicities refer to toxicities experienced during the first 21 days of treatment that have been judged to be clinically significant and at least possibly related to study treatment.
Measured: Up to 21 days
Incidence of adverse events, assessment of clinical laboratory test findings, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements
This composite endpoint will measure the safety profile of momelotinib.
Measured: Up to 2 years
Secondary outcomes (4)
Overall response rate
Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measured: Up to 2 years
Overall survival
Overall survival (OS) is defined as the interval from first dose date of study drug to death from any cause.
Measured: Up to 2 years
Progression-free survival
Progression-free survival (PFS) is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is progression based on RECIST criteria v1.1.
Measured: Up to 2 years
Pharmacokinetic (PK) profile of momelotinib (MMB)
This composite endpoint will measure the plasma PK profile of momelotinib (MMB). The following parameters will be measured, where applicable:
- Cmax: maximum observed concentration of drug in plasma
- Ctau: observed drug concentration at the end of the dosing interval
- AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)
Measured: Predose and postdose on Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study start5 Nov 2014
- Primary completion8 Mar 2017
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Metastatic Pancreatic Ductal AdenocarcinomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244489
- Sponsor's protocol ID
- GS-US-370-1369
- Status last verified
- Jan 2019
- First submitted
- 17 Sep 2014
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study Evaluating Momelotinib Combined With Capecitabine and Oxaliplatin in Subjects With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02244489
- Acronym / sponsor ID
- GS-US-370-1369
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sierra Oncology LLC - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 19 Sep 2014 (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 study will evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Momelotinib (MMB)+capecitabine | Experimental | Drug: Momelotinib (MMB), Drug: CapecitabineParticipants will receive momelotinib (MMB)+capecitabine at varying dose levels to determine the MTD for momelotinib (MMB) and capecitabine. |
| Momelotinib (MMB)+capecitabine+oxaliplatin | Experimental | Drug: Momelotinib (MMB), Drug: Capecitabine, Drug: OxaliplatinUpon reaching the MTD for momelotinib (MMB) and capecitabine or if no MTD is reached, participants will receive momelotinib (MMB)+capecitabine at the MTD plus oxaliplatin at varying dose levels to determine the MTD of combination capecitabine, momelotinib (MMB), and oxaliplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Relapsed or refractory metastatic pancreatic adenocarcinoma
- Received 1 prior chemotherapy regimen for metastatic pancreatic ductal adenocarcinoma (not including neoadjuvant and/or adjuvant therapy)
- Measurable disease per RECIST v1.1
- Adequate organ function defined as
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Key exclusion criteria (13 listed)
- Received more than 1 prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma
- Major surgery within 21 days of first dose of study drug
- Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable)
- Chemotherapy, immunotherapy, biologics, and/or investigational therapy within 21 days prior to first dose of study drug
- Known positive status for HIV, chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier
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 |
|---|---|---|
| Momelotinib (MMB)Also: GS-0387, CYT387Momelotinib (MMB) tablet(s) administered orally once or twice daily | Drug | Momelotinib (MMB)+capecitabine, Momelotinib (MMB)+capecitabine+oxaliplatin |
| CapecitabineCapecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment | Drug | Momelotinib (MMB)+capecitabine, Momelotinib (MMB)+capecitabine+oxaliplatin |
| OxaliplatinOxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle. | Drug | Momelotinib (MMB)+capecitabine+oxaliplatin |
Primary outcome
Incidence of dose limiting toxicities
Time frame: Up to 21 days
Dose limiting toxicities refer to toxicities experienced during the first 21 days of treatment that have been judged to be clinically significant and at least possibly related to study treatment.
Incidence of adverse events, assessment of clinical laboratory test findings, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements
Time frame: Up to 2 years
This composite endpoint will measure the safety profile of momelotinib.
4 secondary outcomes
Overall response rate
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Progression-free survival
Time frame: Up to 2 years
Pharmacokinetic (PK) profile of momelotinib (MMB)
Time frame: Predose and postdose on Day 15
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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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.
Gilead Study Director study director
Gilead Sciences
4 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 Momelotinib (MMB), Capecitabine and Oxaliplatin in people with Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma, run by Sierra Oncology LLC - a GSK company at 4 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 13 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: stopped early, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early. Results are not available in the source record.
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?
Incidence of dose limiting toxicities (time frame: Up to 21 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 1 Feb 2019.