A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer

Conditions

• Breast Cancer
• Breast Cancer Stage IV
• HER2-negative Breast Cancer
• MEK1 Gene Mutation
• MEK2 Gene Mutation
• Metastatic Breast Cancer
• Solid Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mirdametinib — DRUG
  Dose Level -2INT: 2mg PO BID, 3 weeks on/1 week off Dose Level -2: 2mg PO BID given continuously Dose Level -1INT: 3mg PO BID, 3 weeks on/1 week off Dose Level -1: 3mg PO BID given continuously Dose Level 1: 4mg PO BID given continuously Dose Level 2: 6mg PO BID given continuously Dose Level 3: 8mg PO BID given continuously
• Fulvestrant — DRUG
  The starting dose of mirdametinib in combination with fulvestrant in each Dose Level will be as follows: * Dose Level 1: mirdametinib 4 mg BID PO + fulvestrant * (Only to be triggered pending DLTs on higher Dose Levels as described below) * Dose Level -2: mirdametinib 2 mg BID PO continuous + fulvestrant, and Dose Level -2INT: mirdametinib 2 mg BID PO on 3 weeks on, 1 week off + fulvestrant

Study Details

The purpose of this study to find out whether mirdametinib is a safe treatment for people with advanced solid tumor cancer that has certain mutations. Researchers will look at whether mirdametinib on its own or in combination with the drug fulvestrant is a safe treatment that causes few or mild side effects in people with advanced solid tumor cancer.

Key Dates

First listed

Sep 23, 2021

Start date

Sep 14, 2021

Status verified

May 2025

Primary completion

Oct 26, 2023

Completion

Oct 26, 2023

Study Design

Enrollment

6 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1, Part 1 - mirdametinib in combination with fulvestrant
  Postmenopausal patients with estrogen receptor positive metastatic breast cancer harboring NF1 loss of function or another alteration of the MAPK pathway. Part 1: safety run-in (confirmation of the RP2D for mirdametinib in combination with the standard recommended dose of fulvestrant). This part may include the mirdametinib dose de-escalation according to the 3+3 design if necessary
• Experimental: Arm 1, Part 2 - mirdametinib in combination with fulvestrant
  Postmenopausal patients with estrogen receptor positive metastatic breast cancer harboring NF1 loss of function or another alteration of the MAPK pathway. Part 2: dose expansion cohorts where the mirdametinib RP2D will be administered in combination with the standard recommended dose of fulvestrant
• Experimental: Arm 2, Part 1 - mirdametinib as single agent
  Adult patients with advanced solid cancers driven by the alteration of the MAPK pathway Part 1: mirdametinib dose escalation to MTD or RP2D according to the 3+3 design
• Experimental: Arm 2, Part 2 - mirdametinib as single agent
  Adult patients with advanced solid cancers driven by the alteration of the MAPK pathway Part 2: dose expansion cohorts

Primary Outcome Measure

Dose Limiting Treatment/DLT Evaluable Population [ Time Frame: 28 days from first day of treatment ]

Locations (4)

Find similar trials in Middletown, NJ

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