Clinical Trial of Chemotherapy and Bemcentinib for Metastatic Pancreatic Cancer

NCT03649321 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: STU 062018-024
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the overall response rate (ORR) of bemcentinib plus chemotherapy (nab-paclitaxel/gemcitabine) in patients with metastatic pancreatic adenocarcinoma.

Conditions

Cancer of Pancreas

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.

• Clinical Benefit Rate

  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

  Every 4 months from time of first dose of study drug until completion of treatment for approximately 42 months.

Study Arms (2)

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.

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.

Drug: Bemcentinib; Drug: Nab-paclitaxel; Drug: Gemcitabine

Interventions

Bemcentinib DRUG

200mg orally starting Cycle 1 day 2 every 21 days or 28 days.

Phase 1b; Phase 2

Nab-paclitaxel DRUG

25 mg/m\^2 Day 1 /8 every 21 days or 28 days.

Also known as: ABI-007, PACLITAXEL

Phase 1b; Phase 2

Gemcitabine DRUG

Gemcitabine 1000 mg/m\^2 Day 1 /8 every 21 days or 28 days

Also known as: GemzarTM

Phase 1b; Phase 2

Cisplatin DRUG

Cisplatin 25 mg/m\^2 Day 1 /8 every 21 days

Phase 1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• 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):

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Triligent International: collaborator
• Translational Genomics Research Institute: collaborator
• BerGenBio ASA: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9179, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

bemcentinib; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Paclitaxel; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Dr. Syed Kazmi
• Organization: UT Southwestern Medical Center

syed.kazmi@utsouthwestern.edu

214-648-4180

Study Officials

• Syed Kazmi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 28, 2018
• Study Start: January 3, 2019
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: November 9, 2023
• Results First Posted: November 9, 2023

Record last verified: 2023-10

Locations

US (1)