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Pancreatic Adenocarcinoma MetastaticPhase 1/2NCT03127124

QUILT-2.022 NANT-008 in Combination w/ 5-fluorouracil, Bevacizumab, Leucovorin & Oxaliplatin in Subjects With Pancreatic Cancer

A Phase 1/2 study testing NANT-008, Fluorouracil Injectable Product and Avastin Injectable Product in people with Pancreatic Adenocarcinoma Metastatic, run by NantPharma, LLC at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase 1b/2 study to evaluate the safety and efficacy of NANT-008 in combination with 5-fluorouracil, bevacizumab, leucovorin, and oxaliplatin in patients with metastatic pancreatic adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pancreatic Adenocarcinoma Metastatic
What is being tested?
NANT-008, Fluorouracil Injectable Product and Avastin Injectable Product
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
27 Feb 2018to 6 Dec 2023
Phase
Phase 1/2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subject is between ≥ 18 and ≤ 65 years of age at the time of signing the informed consent form (ICF).
  • Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
  • Histologically confirmed, unresectable, locally advanced or metastatic pancreatic adenocarcinoma.
  • ECOG performance status of 0 to 1.
  • Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1.
  • Have not received any prior treatment other than radiation therapy for symptomatic pain relief.
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  • Resolution of all toxic side effects of prior chemotherapy, radiotherapy, or surgical procedures to CTCAE grade ≤ 1, with the exception of alopecia.
  • Must be willing to provide pre- and post-treatment blood samples for exploratory analyses.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Must have a recent FFPE tumor biopsy specimen following the conclusion of the most recent anticancer treatment and be willing to release the specimen for tumor molecular profiling analysis. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
  • Agreement to practice effective contraception (both male and female subjects, if the risk of conception exists).
  • Must have a stable, functioning stent at least 2 weeks before the beginning of the study (metal stents are preferred as per NCCN guidelines) if subject has had a previous biliary or pancreatic duct obstruction requiring stent placement.

Who cannot join

  • History of previous systemic chemotherapy or investigational therapy.
  • History of other active malignancies or brain metastasis except: controlled basal cell carcinoma or squamous cell carcinoma; prior history of in situ cancer (eg, breast, melanoma, squamous cell carcinoma of the skin, cervical) and > 5 years without evidence of disease; prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy) and with undetectable PSA (< 0.2 ng/mL).
  • Inadequate organ function, evidenced by the following laboratory results:
  • White blood cell (WBC) count < 3,500 cells/mm3
  • Absolute neutrophil count < 1,500 cells/mm3.
  • Platelet count < 100,000 cells/mm3.
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  • Hemoglobin < 9 g/dL.
  • Total bilirubin greater than the upper limit of normal (ULN) at time of enrollment; unless the subject has known history of Gilbert's syndrome.
  • Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
  • Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases).
  • Serum creatinine > 2.0 mg/dL or 177 μmol/L.
  • International normalized ratio (INR) or activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) >1.5 × ULN.
  • Pre-existing peripheral neuropathy > grade 1 based on NCI CTCAE V4.03.
  • Dihydropyrimidine dehydrogenase gene polymorphism (DPYD*2A) (must be tested prior to inclusion).
  • Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  • Positive results of screening test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  • Undergone major surgery, other than diagnostic surgery (ie, surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to day 1 of treatment in this study or surgical wound has not fully healed.
  • History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
  • Evidence of gastric ulcers, gastrointestinal fistulas, and gastrointestinal perforations.
  • History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies that in the opinion of the Investigator may put them at increased risk of interstitial pneumonitis.
  • Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
  • Recent history of clinically significant hemoptysis.
  • Known hypersensitivity to any component of the study medication(s).
  • Pregnant and nursing women.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Concurrent or prior use of a strong CYP3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
  • Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chan Soon-Shiong Institutes for Medicine

    El Segundo, California, 90245

Other trials in United States

About this study

Official title: An Open-label, Multicenter, Single-arm, Phase 1b/2 Study of NANT-008 in Combination With 5-fluorouracil, Bevacizumab, Leucovorin, and Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma.

This is a phase 1b/2 study to evaluate the safety and efficacy of NANT-008 in combination with 5-fluorouracil, bevacizumab, leucovorin, and oxaliplatin in patients with metastatic pancreatic adenocarcinoma.

Read the detailed description

Phase 1b is designed to evaluate the recommended phase 2 dose (RP2D) of NANT-008 and dose-limiting toxicities (DLTs) of NANT-008 in combination with metronomic 5-FU, bevacizumab, leucovorin, and oxaliplatin in subjects with advanced metastatic pancreatic carcinoma. In phase 2, subjects will receive the combination of RP2D of NANT-008 from phase 1b in combination with metronomic 5-FU, bevacizumab, leucovorin, and oxaliplatin. Phase 2 is designed to evaluate the efficacy of the tested regimen as assessed by 1-year survival rate in subjects with advanced metastatic pancreatic adenocarcinoma.

Being tested
NANT-008, Fluorouracil Injectable Product, Avastin Injectable Product, Leucovorin Calcium Injection, Eloxatin Injectable Product

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NANT-008Drug

    Paclitaxel: benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI)

  • Fluorouracil Injectable ProductDrug

    5-fluoro-2,4 (1H,3H)-pyrimidinedione.

  • Avastin Injectable ProductDrug

    Recombinant humanized monoclonal IgG1 antibody

  • Leucovorin Calcium InjectionDrug

    Calcium N -[p -[[[(6RS )-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1).

  • Eloxatin Injectable ProductDrug

    cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum.

Study groups in NCT03127124
Study groupRoleWhat they receive
NANT-008 in combination with other agentsExperimentalNANT-008 will be administered in combination with 5-fluorouracil, bevacizumab, leucovorin, and oxaliplatin in patients with metastatic pancreatic adenocarcinoma.
Receives: Drug: NANT-008; Drug: Fluorouracil Injectable Product; Drug: Avastin Injectable Product; Drug: Leucovorin Calcium Injection; Drug: Eloxatin Injectable Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b Primary Endpoint

    Determine the recommended phase 2 dose (RP2D) of NANT-008 and dose-limiting toxicities (DLTs) of NANT-008

    Measured: 12 weeks

  2. Phase 2 Primary Endpoint

    Evaluate the efficacy of the tested regimen as assessed by the 1 year survival rate

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start27 Feb 2018
  3. Primary completion6 Dec 2023
  4. Study completion6 Dec 2023

Why it stopped: This study was withdrawn due to no enrollment

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03127124
Sponsor's protocol ID
QUILT-2.022
Status last verified
Jun 2020
First submitted
20 Apr 2017
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NANT-008, Fluorouracil Injectable Product and Avastin Injectable Product in people with Pancreatic Adenocarcinoma Metastatic, run by NantPharma, LLC 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 12 inclusion and 27 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: withdrawn, as of the sponsor's last update on 2 Apr 2024. 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?

The study was withdrawn before enrolling participants, so there are no results.

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 Primary Endpoint (time frame: 12 weeks). 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?

On the ClinicalTrials.gov record for NCT03127124.

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 2 Apr 2024.

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