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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
Study Summary
This trial looks at whether a new drug, ORIN 1001, can shrink tumors in people with advanced cancer that has continued to grow despite treatment.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreOther outcome measures
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 moreSide effects data
From 2019 Phase 2 trial • 32 Patients • NCT0207348769%
Liver Function Abnormality
50%
Fatigue
44%
Diarrhea
38%
Hypokalemia
19%
Neuropathy
19%
Rash
19%
Nausea
6%
Breast pain
6%
Musculoskeletal pain
6%
Hypomagnesemia
6%
Mucositis
6%
Depression
6%
Anxiety
6%
Chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab + Pertuzumab + Paclitaxel
T-DM1 + Lapatinib + Abraxane
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
Find a Location
Who is running the clinical trial?
Orinove, Inc.Lead Sponsor
2 Previous Clinical Trials
374 Total Patients Enrolled
Mothaffar F Rimawi, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
610 Total Patients Enrolled
1 Trials studying Breast Cancer
12 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have brain metastases that are not being controlled or causing symptoms. If you had brain metastases in the past, but they have been treated and are stable for at least 28 days, you may be able to participate. If you haven't used steroids for at least 2 weeks before joining the study, you can also participate.You are expected to live for 3-4 months.Your ability to perform daily activities is between normal and slightly restricted.You have not responded to the most recent dose of Abraxane and it was given at least 12 months before starting the new treatment. This applies only to the combination treatment group.You must be 18 years or older.You have received certain types of treatments within a specific time period before starting the study drug, unless you have certain medical conditions or need specific medications.You have severe heart failure according to the New York Heart Association (NYHA) criteria.You have uncontrolled HIV, hepatitis B, hepatitis C, or any other active and uncontrolled infections.You have an autoimmune disease that is not well controlled with treatment.You have a history of cancer, but it has been treated and you have been cancer-free for at least 3 years.You have severe nerve damage in the combination arm of the study.You have advanced solid tumors for which there are no effective standard treatments available.You have at least one noticeable and measurable abnormality according to specific guidelines.Your organs and bone marrow should be working well, and there should be enough tissue sample for testing.People with advanced breast cancer that hasn't responded to at least two treatments, and there are no other treatments available that could help.Any side effects from your previous treatment must be mostly gone or very mild.Men or women with metastatic breast cancer that has come back after treatment and does not respond to treatment, including a type called triple-negative breast cancer, as well as another type called hormone receptor-positive, HER2-negative breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Dose Escalation
- Group 2: Phase 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other trials have been conducted to assess the efficacy of Abraxane?
"Currently, 832 Abraxane trials are underway and 227 of them have advanced to Phase 3. The primary concentration is located in Adelaide, South Australia; however, 45681 other medical sites globally are running clinical tests for this medication."
Answered by AI
How many participants has this trial recruited thus far?
"Affirmative. According to clinicaltrials.gov, this research experiment is actively recruiting volunteers since its posting on the 25th of May 2019 and last update 20th July 2022. The study necessitates 150 participants from 22 sites participating in it."
Answered by AI
Are there still opportunities for people to join this clinical experiment?
"Clinicaltrials.gov confirms the ongoing recruitment for this medical trial, which was initially launched on May 25th 2019 and last updated on July 20th 2022."
Answered by AI
What are the desired effects of this scientific investigation?
"The primary outcome of this trial -- evaluated over a period extending from the first dose to 21 days after the last dose-- is assessing MTD/RP2D ORIN1001's safety when administered orally in subjects with advanced solid tumors, as per NCI CTCAEv5 Common Toxicity Criteria. The secondary objectives include determining area under the plasma concentration versus time curve (AUC) for ORIN1001 following single doses; measuring its elimination constant (λz); and gauging its volume of distribution (Vz/f)."
Answered by AI
How many medical centers are actively participating in this clinical trial?
"The clinical trial is conducted in a selection of 22 health facilities, such as Baylor College of Medicine Medical Center (Houston, Texas), NYU Langone Health (New york City) and University of Colorado Anschutz Medical Campus (Denver, CO)."
Answered by AI
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