Health TrialsbyHealthPanel

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

ConditionsTumor, SolidPancreatic CancerMelanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

Age ≥ 18 years at the time of consent (no upper age limit)

Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted standard of care

Disqualifiers

Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on the study)

Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to day -6 of ulixertinib

A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).

Major surgery within 28 days prior to day -6 of ulixertinib

Trial design

Design model

Single group

Treatments tested in this trial

  • Ulixertinib

    Drug

    Ulixertinib 300mg, orally, twice a day concomitantly with palbociclib

  • Palbociclib

    Drug

    Drug: Palbociclib 125mg, orally, once a day concomitantly with ulixertinib

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Open-label, single arm Phase IExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD)

MTD of ulixertinib in combination with palbociclib in patients with advanced solid tumors of ulixertinib in combination with palbociclib in patients with advanced solid tumors

Time frame
Five weeks
2

Overall Survival

For Expansion Cohort: To estimate overall survival (OS) after treatment with the recommended phase 2 dose of ulixertinib in combination with palbociclib in an expansion cohort of patients with metastatic pancreatic cancer

Time frame
6 months after treatment

Secondary outcomes

1

Safety (number of patients with adverse events)

Number of patients with adverse events

Time frame
5 weeks
2

Objective Response Rate

To estimate objective response rate (ORR) after treatment with ulixertinib in combination with palbociclib

Time frame
8 weeks
3

Progression-free survival

To estimate progression-free survival (PFS) after treatment with ulixertinib in combination with palbociclib

Time frame
Up to two years after treatment
4

Overall Survival

For Expansion Cohort: To estimate overall survival (OS) after treatment with the recommended phase 2 dose of ulixertinib in combination with palbociclib in an expansion cohort of patients with metastatic pancreatic cancer

Time frame
Up to two years after treatment

Other outcomes

Sponsors and contacts

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

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

BioMed Valley Discoveries, Inc

Collaborator

Pfizer

Collaborator

Source ClinicalTrials.gov
Apply now