Metastatic Pancreatic Ductal AdenocarcinomaPhase 3NCT02101021
Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 3 study testing Momelotinib, Nab-paclitaxel and Gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Sierra Oncology LLC - a GSK company at 4 sites in United States.
Trial summary
There will be two phases to this study. The lead-in phase will evaluate the safety, pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with nab-paclitaxel and gemcitabine (nab-P + G) in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Momelotinib, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Jun 2014to 10 Apr 2017
- Phase
- Phase 3
- 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
- Presence of metastatic pancreatic adenocarcinoma plus 1 of the following:
- Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
- Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin in conjunction with either:
- The presence of a mass in the pancreas, OR
- A history of resected pancreatic adenocarcinoma
- Measurable disease per RECIST v1.1
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- Adequate organ function defined as follows:
- Total bilirubin ≤ 1.25 x upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
- Absolute neutrophil count (ANC) > 1500 cells/mm^3, platelet > 100,000 cells/mm^3, hemoglobin > 9 g/dL
- Serum creatinine < ULN OR calculated creatinine clearance (CrCl) of ≥ 60 ml/min
- Eastern Cooperative Oncology Group (ECOG ) 0 or 1
- Modified Glasgow prognostic score (mGPS) of 1 or 2 at Screening (randomized phase only)
Who cannot join
- Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma
- Currently or previously treated with biologic, small molecule, immunotherapy, chemotherapy, or other agents for metastatic pancreatic carcinoma
- Major surgery within 28 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)
- Known positive status for HIV
- Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C), or hepatitis B or C carrier
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- Peripheral neuropathy ≥ Grade 2
- 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
- History of interstitial pneumonitis and/or require supplemental oxygen therapy
- 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
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, 46506
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase
There will be two phases to this study. The lead-in phase will evaluate the safety, pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with nab-paclitaxel and gemcitabine (nab-P + G) in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. The randomized treatment phase will evaluate the efficacy, safety, and tolerability of nab-P + G with either MMB administered at the MTD or placebo in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. Participants will continue study treatment until disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of treatment. Following treatment, participants will be followed for safety for 30 days and for survival approximately every 3 months for up to 3 years.
- Being tested
- Momelotinib, Placebo to match momelotinib, Nab-paclitaxel, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MomelotinibDrug
Also called GS-0387, CYT387
Tablet (s) administered orally once or twice daily
Placebo to match momelotinibDrug
Placebo to match momelotinib tablets administered orally once or twice daily
Nab-paclitaxelDrug
Intravenously administered over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
GemcitabineDrug
Intravenously administered over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Momelotinib | Experimental | Participants will receive momelotinib plus nab-paclitaxel and gemcitabine. Receives: Drug: Momelotinib; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| Placebo | Placebo comparator | Participants will receive placebo to match momelotinib plus nab-paclitaxel and gemcitabine. Receives: Drug: Placebo to match momelotinib; Drug: Nab-paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events
Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment.
No statistical analysis was planned or performed for this endpoint.
Measured: Up to 28 Days
Randomized Treatment Phase: Overall Survival (OS)
Overall survival was defined as the time interval from first dose date of MMB to death from any cause
Measured: Baseline up to the Date of Death or Censoring, up to 3 years
Secondary outcomes (5)
Lead-In Phase: Overall Survival (OS)
Overall survival was defined as the time interval from first dose date of MMB to death from any cause
Measured: Baseline up to the Date of Death or Censoring, up to 3 years
Lead-In Phase: Progression-Free Survival (PFS)
Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression is progression based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1. Data from survival, non-progressing participants will be censored at the earliest of the time of initiation of anti-tumor therapy other than the study treatment or the last time that lack of definitive disease progression was objectively documented while on study.
Measured: Baseline up to the Date of Event or Censoring, up to 3 years
Lead-In Phase: Overall Response Rate (ORR)
The ORR was defined as the proportion of participants who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) as assessed by RECIST v1.1.
Measured: Baseline up to the Last Tumor Assessment Date, up to 3 years
Randomized Treatment Phase: Progression-Free Survival (PFS)
Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause
Measured: Baseline up to the Date of Event or Censoring, up to 3 years
Randomized Treatment Phase: Overall Response Rate
The ORR was defined as the proportion of subjects who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR)
Measured: Baseline up to the Last Tumor Assessment Date, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study start2 Jun 2014
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
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 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 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
- NCT02101021
- Sponsor's protocol ID
- GS-US-370-1296
- Other IDs
- 2014-004480-20, 2014
- Status last verified
- Jun 2023
- First submitted
- 28 Mar 2014
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase
- ClinicalTrials.gov ID
- NCT02101021
- Acronym / sponsor ID
- GS-US-370-1296
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sierra Oncology LLC - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2014 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Posted 9 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There will be two phases to this study. The lead-in phase will evaluate the safety, pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with nab-paclitaxel and gemcitabine (nab-P + G) in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. The randomized treatment phase will evaluate the efficacy, safety, and tolerability of nab-P + G with either MMB administered at the MTD or placebo in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. Participants will continue study treatment until disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of treatment. Following treatment, participants will be followed for safety for 30 days and for survival approximately every 3 months for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Momelotinib | Experimental | Drug: Momelotinib, Drug: Nab-paclitaxel, Drug: GemcitabineParticipants will receive momelotinib plus nab-paclitaxel and gemcitabine. |
| Placebo | Placebo comparator | Drug: Placebo to match momelotinib, Drug: Nab-paclitaxel, Drug: GemcitabineParticipants will receive placebo to match momelotinib plus nab-paclitaxel and gemcitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Presence of metastatic pancreatic adenocarcinoma plus 1 of the following:
- Measurable disease per RECIST v1.1
- Adequate organ function defined as follows:
- Eastern Cooperative Oncology Group (ECOG ) 0 or 1
- Modified Glasgow prognostic score (mGPS) of 1 or 2 at Screening (randomized phase only)
Key exclusion criteria (13 listed)
- Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma
- Currently or previously treated with biologic, small molecule, immunotherapy, chemotherapy, or other agents for metastatic pancreatic carcinoma
- Major surgery within 28 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)
- Known positive status for HIV
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 |
|---|---|---|
| MomelotinibAlso: GS-0387, CYT387Tablet (s) administered orally once or twice daily | Drug | Momelotinib |
| Placebo to match momelotinibPlacebo to match momelotinib tablets administered orally once or twice daily | Drug | Placebo |
| Nab-paclitaxelIntravenously administered over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle | Drug | Momelotinib, Placebo |
| GemcitabineIntravenously administered over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle | Drug | Momelotinib, Placebo |
Primary outcome
Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events
Time frame: Up to 28 Days
Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment. No statistical analysis was planned or performed for this endpoint.
Randomized Treatment Phase: Overall Survival (OS)
Time frame: Baseline up to the Date of Death or Censoring, up to 3 years
Overall survival was defined as the time interval from first dose date of MMB to death from any cause
5 secondary outcomes
Lead-In Phase: Overall Survival (OS)
Time frame: Baseline up to the Date of Death or Censoring, up to 3 years
Lead-In Phase: Progression-Free Survival (PFS)
Time frame: Baseline up to the Date of Event or Censoring, up to 3 years
Lead-In Phase: Overall Response Rate (ORR)
Time frame: Baseline up to the Last Tumor Assessment Date, up to 3 years
Randomized Treatment Phase: Progression-Free Survival (PFS)
Time frame: Baseline up to the Date of Event or Censoring, up to 3 years
Randomized Treatment Phase: Overall Response Rate
Time frame: Baseline up to the Last Tumor Assessment Date, up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 3 study testing Momelotinib, Nab-paclitaxel and Gemcitabine in people with 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 12 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 29 Jun 2023. 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. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 9 May 2018). 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?
Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events (time frame: 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 29 Jun 2023.