Overview

Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer

Status:
Not yet recruiting
Trial end date:
2024-05-31
Target enrollment:
0
Participant gender:
All
Summary
The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic PDA, including subjects who have received prior neoadjuvant or adjuvant treatment.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Panbela Therapeutics, Inc.
Treatments:
Gemcitabine
Paclitaxel
Criteria
Inclusion Criteria:

- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
Subjects with pancreatic acinar cell carcinoma may also be included.

- Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic
disease must have been diagnosed within the past 3 months; and subject is expected to
receive standard treatment with gemcitabine and nab-paclitaxel. Subjects who have had
planned or prior surgery, such as a Whipple procedure, with or without
neo-adjuvant/adjuvant chemotherapy may be included.

- Life expectancy ≥ 3 months.

- Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI)
scan by RECIST v1.1 criteria.

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

- Adult, age ≥ 18 years, male or female.

- Females of child-bearing potential must have a negative serum pregnancy test within 14
days prior to start of study treatment and must use an adequate method of
contraception during the study. All sexually active males must also use an adequate
method of contraception during the study. Female subjects are considered to be of
childbearing potential unless they are postmenopausal (at least 12 months of
consecutive amenorrhea, without other known or suspected cause) and over 55 years old
or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy or
bilateral oophorectomy, all with surgery at least one month before dosing).

- Adequate bone marrow, hepatic and renal function as outlined in protocol.

- QTc interval ≤ 470 msec at Baseline.

- Willing and able to provide written informed consent: voluntary agreement to
participate in the study following disclosure of risks and procedures required.

Exclusion Criteria:

- Subjects known to be BRCA (BReast CAncer gene) positive.

- Subjects taking metformin. Diabetic subjects on treatment with metformin, or any other
derivative thereof, must discontinue it while on study (other diabetic medications are
allowed).

- History of retinopathy or macular degeneration.

- Evidence of severe or uncontrolled systemic disease or any concurrent condition that,
in the opinion of the Investigator or Medical Monitor, makes it undesirable for the
subject to participate in the study or that would jeopardize compliance with the
protocol. Subjects with pre-existing well-controlled diabetes are not excluded.

- Medical or psychiatric conditions that compromise the subject's ability to give
informed consent or to complete the protocol or a history of non-compliance.

- Presence of islet-cell or pancreatic neuroendocrine tumor or mixed
adenocarcinoma-neuroendocrine carcinoma.

- Symptomatic central nervous system (CNS) malignancy or metastasis. Screening of
asymptomatic subjects without history of CNS metastases is not required.

- Serum albumin < 30 g/L (3.0 g/dL).

- Occurrence of deep vein thrombosis (DVT) or portal vein occlusion, pulmonary embolism
(PE), or other thromboembolic event during screening.

- Presence of known active bacterial, fungal, or viral infection requiring systemic
therapy.

- Known active infection with human immunodeficiency virus (HIV), hepatitis B or C.

- Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary
hypersensitivity reaction.

- Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic
congestive heart failure New York Heart Association (NYHA) class III or IV.

- Pregnant or lactating.

- Major surgery within 4 weeks of the start of study treatment, without complete
recovery.

- Known hypersensitivity to any component of study treatments.

- Participation in any other clinical investigation within 4 weeks of receiving the
first dose of study drug.

- Any history of hydroxychloroquine use (Plaquenil® and other brand names).