ORIN1001 in Patients with Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer
NCT ID: NCT03950570
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
58 participants
INTERVENTIONAL
2019-05-25
2023-01-30
Brief Summary
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Detailed Description
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Phase 1: A dose escalation stage to determine the MTD/RP2D of ORIN1001 when given as a single agent in up to 30 subjects with advanced solid tumors. In addition, a dose escalation stage to determine the MTD/RP2D of daily ORIN1001 in combination with Abraxane given intravenously in up to 18 subjects with relapsed refractory metastatic breast cancer (TNBC or ER+ HER2-).
Phase 2: An expansion stage of ORIN1001 alone (Cohort A: TNBC) and in combination with Abraxane (Cohort B: Myc+; Cohort C: ER+ HER2-, and Cohort D: TNBC) to estimate efficacy in up to 120 subjects with relapsed refractory metastatic breast cancer.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
Phase 2: Dose expansion as a single agent or in combination with Abraxane (breast cancer)
TREATMENT
NONE
Study Groups
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Phase 1a: Dose Escalation with ORIN1001
In patients with advanced solid tumors or metastatic breast cancer: Treatment with a single oral agent, ORIN1001.
ORIN1001
ORIN1001 will be administered as a table as a monotherapy in the dose escalation phase in patients with advanced solid tumors or in combination with Abraxane in patients with relapse, refractory breast cancer
Experimental Phase 1b: Dose escalation - ORIN1001 in combination with Abraxane dose
In patients with Relapsed, refractory metastatic breast cancer: Treatment with a combination of ORIN1001 and Abraxane.
Abraxane
In patients with relapsed. metastatic breast cancer, ORIN1001 will be administered in combination with Abraxane administered by intravenous infusion.
ORIN1001
ORIN1001 will be administered as a table as a monotherapy in the dose escalation phase in patients with advanced solid tumors or in combination with Abraxane in patients with relapse, refractory breast cancer
Interventions
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Abraxane
In patients with relapsed. metastatic breast cancer, ORIN1001 will be administered in combination with Abraxane administered by intravenous infusion.
ORIN1001
ORIN1001 will be administered as a table as a monotherapy in the dose escalation phase in patients with advanced solid tumors or in combination with Abraxane in patients with relapse, refractory breast cancer
Eligibility Criteria
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Inclusion Criteria
-Male or female with advanced solid tumors for which no effective standard of care treatments are available
For dose escalation with ORIN1001 in combination with Abraxane:
-Males or females with relapsed refractory metastatic breast cancer (TNBC or ER+, HER2-) must have progressed through at least 2 lines of therapy and for whom there are no available therapies that confer a clinical benefit
For dose expansion:
a. Males or females with relapsed refractory metastatic breast cancer including:
1. TNBC (i.e. estrogen receptor (ER)-, progesterone receptor-, and human epidermal growth factor receptor 2 \[HER2\]-)
2. ER+ HER2- breast cancer
1. Adults aged ≥ 18 years
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
3. Life expectancy of 3-4 months
4. Have at least one measurable lesion per RECIST 1.1
5. Have adequate organ function, including all of the following:
1. Adequate bone marrow reserve as defined by: ANC≥1.0 x 10 9/L; platelet count ≥75 x 10 9/L; hemoglobin ≥9 g/dL
2. Hepatic: total bilirubin ≤2 x ULN, transaminases (AST/SGOT and/or ALT/SGPT) ≤ 3X ULN;alkaline phosphatase ≤ 5 x ULN
3. Renal: 24-hour creatinine clearance ≥ 30 mL/min calculated
6. Adequate tissue sample from either archival tumor tissue or fresh biopsy of tumor at the screening for tumor genotyping.
7. Male subjects must be surgically sterile or must agree to use physician approved contraception for 7 days prior to the first study drug administration to 30 days after the last dose of study treatment.
8. Women of childbearing potential must have negative serum pregnancy test within 14 days prior the first administration of study drug and agree to use physician-approved contraception from 30 days prior to the first study drug administration to 30 days following the last study drug administration.
9. Ability to understand and willingness to sign an informed consent prior to any study specific procedures.
10. Resolution of all toxicities (except alopecia) from prior therapy to ≤ Grade 1 (CTCAE v5)
2. Received any of the following within the specified time frame prior to the first administration of study drug:
i. Excluding those with a history of coagulopathy ii. Excluding those who require concurrent use of anti-coagulants or anti-platelet medication, with exception of aspirin doses ≤ 81 mg/day, prophylaxis subcutaneous (SC) heparin or SC low-molecular weight heparin for deep vein thrombosis (DVT) prophylaxis or heparin flushes to maintain IV catherer patency iii. Excluding subjects that have Prothrombin time (PT)/international normalized ratio (INR) or activated partial thromboplastin time (aPTT) \>1.5 x ULN b.Prior chemotherapy or other systemic anticancer therapy within 3 weeks or 5 times the plasma half-life of the drug, whichever is shorter; c.Prior radiotherapy within 2 weeks; d.Major surgery within 2 weeks; e.Prior treatment with investigational drugs within 4 weeks; f. Myocardial infarction, uncontrolled angina,severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, within 6 months prior to the fist dose of study drug
3. Greater than Class II heart failure using New York Heart Association (NYHA) criteria
4. The subject has uncontrolled human immunodeficiency virus (HIV) infection or active hepatitis B or C infection or other known active and/or uncontrolled infection
5. Active autoimmune disease that is not appropriately controlled with treatment
6. Active malignancy with the exception of:
1. adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer
2. adequately treated stage I cancer from which the subject is currently in remission, or
3. any other cancer from which the subject has been disease-free for ≥3 years;
7. Any serious uncontrolled medical or psychological disorder that would impair the ability to receive protocol therapy
8. Any condition which places the subject at unacceptable risk or confounds the ability of the investigator to interpret study data
9. The subject is pregnant or lactating woman. Any woman who becomes pregnant during the study will be withdrawn from the study.
10. Known active uncontrolled or symptomatic brain metastases. Patients with a history of such metastases that have been treated and are stable ≥28 days may be enrolled. Patients with no steroid use for at least 2 weeks prior to the time of enrollment are permitted.
11. Failed to respond to the most recent dose of Abraxane and must have been received at least 12 months prior to starting treatment.(combination arm only)
12. Greater than Grade 1 neuropathy (combination arm only)
18 Years
ALL
No
Sponsors
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Orinove, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mothaffar F Rimawi, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
UCLA Health Burbank Specialty Care
Burbank, California, United States
UCLA Health Laguna Hills Cancer Care
Laguna Hills, California, United States
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center (JCCC) - Oncology Center - Westwood
Westwood, Los Angeles, California, United States
University of Colorado Anschutz Medical Campus
Denver, Colorado, United States
Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
University of Colorado Lone Tree Medical Center
Lone Tree, Colorado, United States
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Cancer Center of Kansas
Wichita, Kansas, United States
St Lukes Cancer Institute
Kansas City, Missouri, United States
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
Buffalo, New York, United States
Northwell Health
New Hyde Park, New York, United States
Northwell Heath Cancer Institute
New Hyde Park, New York, United States
NYU Langone Health
New York, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
Countries
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Other Identifiers
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ORIN1001-001
Identifier Type: -
Identifier Source: org_study_id