Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Breast Neoplasms

Recurrence

Inflammatory Breast Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Inflammatory Breast Cancer

Antineoplastic Agents

All Drugs and Chemicals

Halichondrin B

Tubulin Modulators

Antimitotic Agents

Patients receive grapiprant PO BID on day 1-21 and eribulin mesylate IV over 5 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Eribulin Mesylate

Grapiprant

Sadia Saleem

This phase Ib/II trial tests the safety and side effects of grapiprant and eribulin and whether they work to shrink tumors in patients with inflammatory breast cancer that has spread to other places in the body (metastatic). Grapiprant is an anti-inflammatory drug that may prevent tumor growth. Eribulin may block tumor cell growth by stopping tumor cell division. Giving grapiprant and eribulin together may help to control the disease.

PRIMARY OBJECTIVE:

I. To determine the safety and efficacy of grapiprant and eribulin combination treatment for the patient with metastatic inflammatory breast cancer (mIBC).

SECONDARY OBJECTIVES:

I. To determine objective response rate (ORR), % of the patients who achieve complete response (CR) or partial response (PR).

II. To determine the time to progression (TTP) of the proposed treatment. III. To determine the duration of response of the proposed treatment. (Phase 2 only) IV. To determine the time to first response of the proposed treatment. (Phase 2 only) V. To determine progression-free survival (PFS) of the proposed treatment. VI. To determine the overall survival (OS) of the proposed treatment. VII. To investigate the predictive biomarker of the proposed treatment.

EXPLORATORY OBJECTIVE:

I. To evaluate the changes in the tumor microenvironment after the proposed treatment.

OUTLINE:

Patients receive grapiprant orally (PO) twice daily (BID) on day 1-21 and eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then yearly for up to 5 years.

Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer

Phase Ib/II Study of Grapiprant (IK-007) and Eribulin Combination Treatment for Metastatic Inflammatory Breast Cancer (mIBC)

Defined as complete response (CR) + partial response (PR) + stable response (\> 24 weeks). The CBR will be summarized by frequency and percentage with 95% exact confidence intervals for all patients and by doses.

M.D. Anderson Cancer Center

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Single Agent run-in with grapiprant and then combination treatment of grapiprant and pembrolizumab.

Participants will be treated with grapiprant in combination with pembrolizumab.

Cohort 1 will be treated for 1 week with oral grapiprant as a single agent, followed by 21-day combination treatment cycles of oral grapiprant in combination with IV pembrolizumab.

grapiprant

Cohort 2 will be administered 21-day combination treatment cycles of oral grapiprant in combination with IV pembrolizumab.

grapiprant and pembrolizumab

Sergio Santillana, MD

This study will be conducted in adult participants diagnosed with any form of an advanced or progressive MSS CRC for which 1st and 2nd line standard therapy (at least one of which contained fluorouracil) is no longer effective or is intolerable. This is a phase 1b, multi-center, open label study designed to assess safety and tolerability of grapiprant in combination with pembrolizumab, to determine the recommended phase 2 dose (RP2D) with pembrolizumab, and to evaluate and characterize the PK of grapiprant alone and in combination with pembrolizumab. Disease response, pharmacodynamics, and response biomarkers will also be assessed.

Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer

An Open-label, Single-arm, Phase 1b Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination With Pembolizumab in Patients With Advanced or Progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC)

Number of incidence, severity, and duration of treatment emergent adverse events using CTCAE v5.0

Number, incidence and severity of treatment related adverse events as assessed by CTCAE 5.0

Proportion of participants who achieved PR or better during the study per RECIST 1.1

Time when criteria for response are met, to the first documentation of relapse or progression

Participants who discontinue treatment without disease progression

Percentage of participants who achieved a CR, PR and stable disease

Date of study drug to date of death due to any cause. If no documentation of death at time of the analysis will be censored as of the date last known to be alive, or the data cutoff date, whichever is earlier.

Assess changes in serum tumor markers including but not limited to carcinoembryonic antigen (CEA), when appropriate (eg. CA-19.9, CA125, and lactate dehyrogenase (LDH)) with disease response.

Assess changes in tumor infiltrating helper T cells, cytotoxic T cells and regulatory monocyte/macrophages with study drug treatment

Evaluate disease response in all evaluable participants and in those with a positive initial assessment of Urine prostaglandin E2 metabolite (PGEM)

First time to reach maximum \[peak\] observed plasma concentration

Area under the plasma concentration time curve from time 0 to the end of the dosing interval (AUC0 last)

Measurement of half-life of grapiprant after dosing

Rate of elimination of the drug from plasma after oral administration

Measure how drug effect is sustained over dose interval

Relationship between the dosing interval and the rate of elimination for the drug.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer	NCT05041101	Breast Inflamma... Recurrent Breas... Stage IV Breast...	Eribulin Mesyla... Grapiprant	18 Years -	M.D. Anderson Cancer Center
Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer	NCT03658772	Microsatellite ...	grapiprant grapiprant and ...	18 Years -	Arrys Therapeutics
Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer	NCT05041101	Breast Inflamma... Recurrent Breas... Stage IV Breast...	Eribulin Mesyla... Grapiprant	18 Years -	M.D. Anderson Cancer Center
Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer	NCT05041101	Breast Inflamma... Recurrent Breas... Stage IV Breast...	Eribulin Mesyla... Grapiprant	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for grapiprant

Every month we try and update this database with for grapiprant cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for grapiprant

Every month we try and update this database with for grapiprant cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for grapiprant cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.