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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPanbela Therapeutics, Inc.

About this trial

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 pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.

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/or 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.

Disqualifiers

When results of germline or somatic testing done prior to screening are known, subjects known to have mutations of the BRCA 1/2 (Breast Cancer gene) are excluded.

Concomitant metformin administration. Diabetic subjects on treatment with metformin, or any other derivative thereof, must discontinue it at least 5 days prior to C1D1 and not take metformin while on study (other diabetic medications are allowed).

Any history of retinopathy or at risk for retinal detachment (personal or family history of retinal detachment, extreme myopia [-6.0 diopters or approximately 20/500], eye surgery <6 months prior to C1D1, or history of a severe eye injury. Subjects with findings of retinopathy on baseline ophthalmology exams will be excluded.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SBP-101

    Drug

    small molecule polyamine metabolic inhibitor for subcutaneous injection

  • Nab-paclitaxel

    Drug

    paclitaxel protein-bound particles for injectable suspension

  • Gemcitabine

    Drug

    gemcitabine for injection

  • Placebo

    Other intervention

    Normal Saline

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 3 interventions
Group B: Control ArmPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Compare OS between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine

Time frame
From date of first dose up to 100 weeks or until death

Secondary outcomes

1

Progression Free Survival (PFS)

Compare PFS between SBP-101 and placebo

Time frame
From date of first dose up to 100 weeks or until death

Other outcomes

1

Overall Objective Response (ORR)

Compare ORR between SBP-101 and placebo

Time frame
Up to 100 weeks
2

Disease Control Rate (DCR)

Compare DCR between SBP-101 and placebo

Time frame
Up to 100 weeks
3

Duration of Response (DoR)

Compare DoR between SBP-101 and placebo

Time frame
Up to 100 weeks
4

Quality of Life (QOL) Questionnaires: EORTC QLC-C30

Compare QOL changes in scores between SBP-101 and placebo

Time frame
Up to 100 weeks

Sponsors and contacts

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