Cancer of PancreasPhase 1/2NCT03649321
Clinical Trial of Chemotherapy and Bemcentinib for Metastatic Pancreatic Cancer
A Phase 1/2 study testing Bemcentinib, Nab-paclitaxel and Gemcitabine in people with Cancer of Pancreas, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Determine the overall response rate (ORR) of bemcentinib plus chemotherapy (nab-paclitaxel/gemcitabine) in patients with metastatic pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Pancreas
- What is being tested?
- Bemcentinib, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 27 Jun 2022
- 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
- Ability to understand and the willingness to sign a written informed consent.
- Patients must have histologically or cytologically confirmed recurrent or metastatic pancreatic adenocarcinoma.
- No prior systemic therapy for metastatic or recurrent disease.
- Prior adjuvant therapy, if completed more than 6 months prior to date of enrollment, is acceptable.
- Radiosensitizing chemotherapy, if completed at least 4 weeks from date of enrollment, is acceptable.
- Measurable disease per RECIST1.1 criteria
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- Age 18-70 years at the time of enrollment
- ECOG performance status 0 or 1
- Have resolution of toxic effect(s) or intervention complication to Grade 1 or less (except alopecia) from any prior chemotherapy, major surgery, or radiation therapy of >30 Gy.
- Adequate hematologic, hepatic, and renal function. All screening labs should be performed within 14 days of enrollment date.
- Hemoglobin ≥ 10 g/dL
- ANC ≥ 1,500/µL
- Platelets ≥ 100,000/µL
- Total bilirubin < 1.5 x institutional ULN
- AST (SGOT) \& ALT(SGPT)≤ 2.5 x institutional ULN in patients without known liver metastasis; ≤ 5 x institutional ULN in patients with known liver metastasis
- Serum creatinine ≤ 1.5 times ULN, and calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation)
- INR or PT International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 times the ULN
- Albumin ≥ 3.0 g/dL
- Female patients of childbearing potential must have a negative pregnancy test (either urine or serum pregnancy test). If the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 120 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician, or study team member, immediately.
Who cannot join
- Is currently participating and receiving study therapy in a first line setting for metastatic or recurrent pancreatic adenocarcinoma.
- Participated in a study of an investigational agent or used an investigational device within 4 weeks of the first dose of study treatment.
- Patients with known untreated brain metastases. Patients without known or suspected brain metastases do not require radiologic imaging prior to enrollment.
- Has a known additional malignancy that is progressing or requires active treatment. Note: Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, significant pulmonary disease (shortness of breath at rest or mild exertion), or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
- History of the following cardiac conditions:
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- Congestive cardiac failure of >Grade II severity according to the NYHA (defined as symptomatic at less than ordinary levels of activity);
- Ischemic cardiac event including myocardial infarction within 3 months prior to date of enrollment
- Uncontrolled cardiac disease, including unstable angina pectoris, uncontrolled hypertension (i.e. sustained systolic BP >160 mmHg or diastolic BP >90 mmHg), cardiac arrhythmia, or need to change medication due to lack of disease control within 6 weeks prior to date of enrollment;
- History or presence of sustained bradycardia (≤55 BPM), left bundle branch block, cardiac pacemaker or ventricular arrhythmia. Note: Patients with a supraventricular arrhythmia requiring medical treatment, but with a normal ventricular rate are eligible;
- Known family history or personal history of long QTc syndrome or previous drug-induced QTc prolongation of at least Grade 3 (QTc >500 ms).
- Abnormal left ventricular ejection fraction (LVEF) on ECHO or MUGA less than <45%.
- Current treatment with any agent known to cause Torsades de Pointes which cannot be discontinued at least five half-lives or two weeks prior to the first dose of study treatment.
- Screening 12-lead ECG, in triplicate, with a measurable QTc interval according to Fridericia's correction >450 ms.
- Known active infection with human immunodeficiency virus (HIV), hepatitis B or C viruses (screening not required, follow institutional practice):
- Patients who have a history of hepatitis B infection are eligible provided they are hepatitis B surface antigen negative.
- Patients who have a history of hepatitis C infection are eligible provided they have no evidence of hepatitis C ribonucleic acid using a quantitative polymerase chain reaction assay at least 6 months after completing treatment for hepatitis C infection.
- Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
- Treatment with any medication which is predominantly metabolized by CYP3A4 and has a narrow therapeutic index
- Major surgery within 4 weeks prior to date of enrollment; excluding skin biopsies and procedures for insertion of central venous access devices.
- Inability to tolerate oral medication
- Existing gastrointestinal disease affecting drug absorption such as celiac disease or Crohn's disease, or previous bowel resection which is considered to be clinically significant or could interfere with absorption.
- Known lactose intolerance
- Is pregnant or breastfeeding
- Any significant medical condition lab abnormality, or psychiatric illness, in the opinion of the investigator, that might interfere with the patient's participation in the study or in the evaluation of the study results.
- Unwillingness or inability to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9179
About this study
Official title: A phase1b/2 Clinical Trial of Chemotherapy and the AXL-inhibitor Bemcentinib for Patients With Metastatic Pancreatic Cancer
Determine the overall response rate (ORR) of bemcentinib plus chemotherapy (nab-paclitaxel/gemcitabine) in patients with metastatic pancreatic adenocarcinoma.
Read the detailed description
Bemcentinib inhibits pancreatic cancer proliferation as monotherapy and in combination with gemcitabine through inhibition of the Axl pathway. The combination of nab-paclitaxel/gemcitabine has encouraging signs of clinical activity in patients with metastatic pancreatic cancer38. We would like to build on this combination in a biomarker driven phase 1b/2 clinical trial of bemcentinib in nab-paclitaxel/gemcitabine for patients with metastatic pancreatic cancer.
- Conditions
- Cancer of Pancreas
- Being tested
- Bemcentinib, Nab-paclitaxel, Gemcitabine, Cisplatin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemcentinibDrug
200mg orally starting Cycle 1 day 2 every 21 days or 28 days.
Nab-paclitaxelDrug
Also called ABI-007, PACLITAXEL
25 mg/m^2 Day 1 /8 every 21 days or 28 days.
GemcitabineDrug
Also called GemzarTM
Gemcitabine 1000 mg/m^2 Day 1 /8 every 21 days or 28 days
CisplatinDrug
Cisplatin 25 mg/m^2 Day 1 /8 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b | Experimental | bemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m^2 Day 1 /8 every 21 days. Receives: Drug: Bemcentinib; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Cisplatin |
| Phase 2 | Experimental | bemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m^2 Day 1 /8 /15 every 28 days. Receives: Drug: Bemcentinib; Drug: Nab-paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Determine the clinical activity as defined by overall response rate (ORR) of bemcentinib plus chemotherapy (nab-paclitaxel/gemcitabine) in patients with metastatic pancreatic adenocarcinoma. The analyses of ORR was performed on the Response Evaluable Population. ORR is defined as the proportion of patients with CR+partial response as their best clinical response.
Measured: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.
Secondary outcomes (3)
Complete Response Rate (CR)
Determine clinical activity of bemcentinib plus chemotherapy as defined by complete response rate (CRR), partial response, stable disease, duration of response - overall response/stable disease, median progression free survival (PFS) and overall survival (OS) rate.
Measured: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.
Clinical Benefit Rate
Determine clinical benefit rate as defined by complete response (CR), Partial Response (PR), and Stable Disease (SD) response rates. Clinical benefit response - percent of CR, PR, and SD.
Measured: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.
Number of Participants With an Adverse Event of Grade 3 or Higher
Assess safety and tolerability of bemcentinib plus chemotherapy in patients with metastatic pancreatic adenocarcinoma and will be graded according to the NCI CTCAE, Version 5
Measured: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start3 Jan 2019
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
Why it stopped: Funding was terminated early because research interests were going in a different direction.
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 Cancer of PancreasStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Triligent International, Translational Genomics Research Institute, BerGenBio ASA
- Responsible party
- Principal investigator, Syed Kazmi, University of Texas Southwestern Medical Center
- Investigators
- Syed Kazmi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649321
- Sponsor's protocol ID
- STU 062018-024
- Status last verified
- Oct 2023
- First submitted
- 16 Aug 2018
- Last updated
- 9 Nov 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A phase1b/2 Clinical Trial of Chemotherapy and the AXL-inhibitor Bemcentinib for Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03649321
- Acronym / sponsor ID
- STU 062018-024
- Conditions
- Cancer of Pancreas
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was terminated early because research interests were going in a different direction.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Triligent International, Translational Genomics Research Institute, BerGenBio ASA
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 9 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the overall response rate (ORR) of bemcentinib plus chemotherapy (nab-paclitaxel/gemcitabine) in patients with metastatic pancreatic adenocarcinoma.
Detailed description
Bemcentinib inhibits pancreatic cancer proliferation as monotherapy and in combination with gemcitabine through inhibition of the Axl pathway. The combination of nab-paclitaxel/gemcitabine has encouraging signs of clinical activity in patients with metastatic pancreatic cancer38. We would like to build on this combination in a biomarker driven phase 1b/2 clinical trial of bemcentinib in nab-paclitaxel/gemcitabine for patients with metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1b | Experimental | Drug: Bemcentinib, Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Cisplatinbemcentinib 200 mg oral daily every 21 days. Nab-paclitaxel 100 mg/m^2 Day 1 /8 every 21 days. Gemcitabine 800 mg/m^2 Day 1 /8 every 21 days. Cisplatin 25 mg/m^2 Day 1 /8 every 21 days. |
| Phase 2 | Experimental | Drug: Bemcentinib, Drug: Nab-paclitaxel, Drug: Gemcitabinebemcentinib 200 mg oral daily every 28 days. Nab-paclitaxel 125 mg/m^2 Day 1 /8 /15 every 28 days. Gemcitabine 1000 mg/m^2 Day 1 /8 /15 every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Ability to understand and the willingness to sign a written informed consent.
- Patients must have histologically or cytologically confirmed recurrent or metastatic pancreatic adenocarcinoma.
- No prior systemic therapy for metastatic or recurrent disease.
- Measurable disease per RECIST1.1 criteria
- Age 18-70 years at the time of enrollment
Key exclusion criteria (26 listed)
- Is currently participating and receiving study therapy in a first line setting for metastatic or recurrent pancreatic adenocarcinoma.
- Participated in a study of an investigational agent or used an investigational device within 4 weeks of the first dose of study treatment.
- Patients with known untreated brain metastases. Patients without known or suspected brain metastases do not require radiologic imaging prior to enrollment.
- Has a known additional malignancy that is progressing or requires active treatment. Note: Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, significant pulmonary disease (shortness of breath at rest or mild exertion), or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Bemcentinib200mg orally starting Cycle 1 day 2 every 21 days or 28 days. | Drug | Phase 1b, Phase 2 |
| Nab-paclitaxelAlso: ABI-007, PACLITAXEL25 mg/m^2 Day 1 /8 every 21 days or 28 days. | Drug | Phase 1b, Phase 2 |
| GemcitabineAlso: GemzarTMGemcitabine 1000 mg/m^2 Day 1 /8 every 21 days or 28 days | Drug | Phase 1b, Phase 2 |
| CisplatinCisplatin 25 mg/m^2 Day 1 /8 every 21 days | Drug | Phase 1b |
Primary outcome
Overall Response Rate (ORR)
Time frame: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.
Determine the clinical activity as defined by overall response rate (ORR) of bemcentinib plus chemotherapy (nab-paclitaxel/gemcitabine) in patients with metastatic pancreatic adenocarcinoma. The analyses of ORR was performed on the Response Evaluable Population. ORR is defined as the proportion of patients with CR+partial response as their best clinical response.
3 secondary outcomes
Complete Response Rate (CR)
Time frame: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.
Clinical Benefit Rate
Time frame: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.
Number of Participants With an Adverse Event of Grade 3 or Higher
Time frame: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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.
Syed Kazmi, MD principal investigator
University of Texas Southwestern Medical Center
1 site 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 Bemcentinib, Nab-paclitaxel and Gemcitabine in people with Cancer of Pancreas, run by University of Texas Southwestern Medical Center at 1 site 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 22 inclusion and 26 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 9 Nov 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?
Overall Response Rate (ORR) (time frame: Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.). 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 Nov 2023.