What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as tamoxifen, aromatase inhibitors, and chemotherapy, have well-documented side effects. Tamoxifen can cause hot flashes, vaginal dryness, and an increased risk of blood clots. Aromatase inhibitors may lead to loss of bone density, fractures, and cardiovascular risks. Chemotherapy often results in fatigue, nausea, hair loss, and increased susceptibility to infections. These side effects are important considerations for patients undergoing treatment for advanced or relapsed refractory metastatic breast cancer.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of advanced or metastatic breast cancer. Trastuzumab deruxtecan and trastuzumab emtansine are targeted therapies approved for HER2-positive metastatic breast cancer. Hormone therapies such as tamoxifen and aromatase inhibitors (letrozole, anastrozole) are used for hormone receptor-positive breast cancer. Chemotherapy agents like doxorubicin and paclitaxel are also commonly used. Additionally, the combination of BRAF and MEK inhibitors, dabrafenib and trametinib, has been approved for BRAF V600E-mutated tumors, which includes certain breast cancers. These treatments represent a range of mechanisms aimed at targeting specific pathways involved in breast cancer progression.

What other types of research exist?

Promising novel alternatives to ORIN 1001 for breast cancer patients include: 1) Trastuzumab deruxtecan, which has shown efficacy in HER2-overexpressing metastatic breast cancer. 2) The combination of fulvestrant plus everolimus, which has been demonstrated to be safe and effective for hormone-receptor positive, HER2-negative breast cancer. 3) Buparlisib, a pan-PI3K inhibitor, which has shown activity in combination with fulvestrant for certain breast cancer subtypes.

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Other

ORIN1001 for Advanced Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Mothaffar F Rimawi, MD

Research Sponsored by Orinove, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ORIN 1001, a new drug, on patients with advanced cancers that haven't responded to previous treatments. Researchers want to find the best dose and see if it can slow down or stop cancer growth, alone or with another drug called Abraxane.

Who is the study for?

This trial is for adults with advanced solid tumors or relapsed refractory metastatic breast cancer who've had at least two prior treatments fail. They must have a life expectancy of 3-4 months, be in fair health (ECOG 0-2), and agree to use contraception. Those with certain heart conditions, uncontrolled infections, active autoimmune diseases, or untreated brain metastases cannot join.

What is being tested?

The study tests ORIN1001's effectiveness against advanced solid tumors and metastatic breast cancer that's resistant to other treatments. Some patients will receive ORIN1001 alone; others will get it combined with Abraxane—a chemotherapy drug—to see which works better.

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues like fatigue, nausea, hair loss (alopecia), nerve damage (neuropathy), and possibly more severe reactions due to the new drug ORIN1001 which are not fully known yet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the safety MTD/RP2D of daily ORIN1001 when administered orally in combination with paclitaxel given intravenously at 175 mg/m2 once every three weeks in subjects with relapsed refractory metastatic breast cancer

Neoplasms

To evaluate the safety and tolerability of daily ORIN1001 when administered orally in combination with Abraxane given intravenously at 100 mg/m2 once weekly for 3 weeks in the dose escalation and expansion stages of the study

+1 more

Secondary study objectives

To evaluate the area under the plasma concentration versus time curve (AUC) of ORIN1001 after oral administration as a single agent and in combination with Abraxane.

To evaluate the average plasma concentration (Cav) of ORIN1001 after oral administration as a single agent and in combination with Abraxane.

To evaluate the elimination constant (λz) of ORIN1001 after oral administration as a single agent and in combination with Abraxane.

+8 more

Other study objectives

Therapeutic procedure

To measure the duration of progression free survival (PFS) in patients receiving ORIN1001 alone and in combination with Abraxane

To measure the response duration in patients receiving ORIN1001 alone and in combination with Abraxane.

+7 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT02073487

69%

Liver Function Abnormality

50%

Fatigue

44%

Diarrhea

38%

Hypokalemia

19%

Neuropathy

19%

Rash

19%

Nausea

Breast pain

Musculoskeletal pain

Hypomagnesemia

Mucositis

Depression

Anxiety

Chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab + Pertuzumab + Paclitaxel

T-DM1 + Lapatinib + Abraxane

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: Dose ExpansionExperimental Treatment1 Intervention

Relapsed refractory metastatic breast cancer that are Triple negative, ER+ or HER2- and treated with a single agent (ORIN1001) or in combination with ORIN1001 and Abraxane.

Group II: Phase 1: Dose EscalationExperimental Treatment1 Intervention

Advanced solid tumors or metastatic breast cancer: Treatment with a single oral agent, ORIN1001. Relapsed, refractory metastatic breast cancer: Treatment with a combination of ORIN1001 and Abraxane.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abraxane

2008

Completed Phase 2

~610

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for breast cancer include therapies targeting the estrogen receptor (ER) and HER2 pathways, as well as CDK4/6 inhibitors. ER-targeted therapies, such as tamoxifen and aromatase inhibitors, work by blocking the hormone estrogen, which can promote the growth of breast cancer cells. HER2-targeted therapies, like trastuzumab, inhibit the HER2 protein, which is overexpressed in some breast cancers and drives cell proliferation. CDK4/6 inhibitors, such as palbociclib, interfere with cell cycle progression, thereby preventing cancer cell division. Understanding these mechanisms is crucial for breast cancer patients as it helps in selecting the most effective treatment based on the specific characteristics of their tumor, potentially improving outcomes and managing resistance to therapy.

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