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Samuraciclib in Combination With Gemcitabine/Nab-Paclitaxel in Patients With Metastatic Basal-Like Pancreatic Cancer

ConditionsPancreas Ductal AdenocarcinomaPancreas Cancer, MetastaticPancreatic Adenocarcinoma MetastaticAdenosquamous Carcinoma of the PancreasMucinous Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

The purpose of this study is to find the highest dose of a drug, samuraciclib, that can be given with standard of care chemotherapy (gemcitabine and nab-paclitaxel) without causing very severe side effects. This is done by starting at a dose lower than the one that is used when samuraciclib is taken by itself without chemotherapy. The main question it aims to answer is:

• For patients with newly diagnosed metastatic pancreatic cancer, what is the safety and tolerability of samuraciclib with gemcitabine/nab-paclitaxel?

Participants will:

* Undergo a tumor biopsy. * Be treated with samuraciclib in combination with their standard of care chemotherapy (gemcitabine/nab-paclitaxel). * Donate research blood samples.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years at the time of screening.

Written informed consent and any locally required authorization (eg, data privacy) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening.

Must have life expectancy ≥ 12 weeks at the time of screening.

Disqualifiers

Participants receiving any other study agents concurrently with the study drugs.

Known homologous recombination deficient pancreatic cancer, including germline or somatic BRCA1/2 or PALB2 mutations

Concurrent enrolment in another therapeutic clinical study. Enrolment in observational or supportive care studies will be allowed.

History of a malabsorption syndrome or uncontrolled nausea, vomiting, or diarrhea that may interfere with the absorption of oral study medication in the opinion of the investigator.

Trial design

Design model

Single group

Treatments tested in this trial

  • Samuraciclib + Gemcitabine & Nab-Paclitaxel

    Drug

    Starting dose level: Samuraciclib 240 mg taken orally, once daily. Gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8 and 15.

Treatment groups

67 Participants
are divided into 1 treatment group
Group A: Samuraciclib + GnPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequencies of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level

Time frame
From date of enrollment to date off treatment, assessed up to 24 months
2

Percentages of adverse events (AEs), as graded by CTCAE v6.0 and reported by dose level

Time frame
From date of enrollment to date off treatment, assessed up to 24 months
3

Frequencies of dose-limiting toxicities reported by dose level

Time frame
From date of enrollment to date off treatment, assessed up to 24 months
4

Percentages of dose-limiting toxicities reported by dose level

Time frame
From date of enrollment to date off treatment, assessed up to 24 months

Secondary outcomes

1

Objective response rate (ORR)

Defined as the proportion of participants who achieve a Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 best overall response of confirmed complete response (CR) or confirmed partial response (PR)

Time frame
From date of enrollment to date off treatment, assessed up to 24 months
2

Progression-free survival (PFS)

Defined as the duration of time from start of treatment to time of disease recurrence/progression (PD) or death from any cause, whichever occurs first.

Time frame
From date of enrollment to date of first progression or death, assessed up to 24 months
3

Overall survival (OS)

Defined as the duration of time from time of diagnosis to death.

Time frame
From date of enrollment to date of death, assessed up to 24 months
4

Duration of overall response (DOR)

Defined as the duration of time from when measurement criteria are met for CR or PR (whichever is first recorded) until the date that recurrent/progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started).

Time frame
From date of enrollment to date of first progression, assessed up to 24 months

Other outcomes

1

Comparison of PDAC transcriptional subtype (basal vs classical) between baseline and 8 week sample

Evaluate translational biomarkers related to CDK7 inhibition with samuraciclib by comparing tissue and blood samples at pre-treatment and at 8 weeks.

Time frame
From enrollment to 8 weeks on treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: