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New treatment option for Metastatic Malignant Solid Neoplasm
Official title Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer
ClinicalTrials.gov ID: NCT04585958
What this study is testing
What is Olaparib?
Olaparib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic malignant solid neoplasm.
Also referred to as AZD 2281, AZD-2281.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial identifies the side effects and best dose of DS-8201a and olaparib in treating patients with HER2-expressing cancers that have spread to other places in the body or cannot be removed by surgery or ovarian cancer that remains despite treatment with a platinum treatment (platinum resistant). Olaparib is a drug that blocks an enzyme involved in many cell functions, including the repair of deoxyribonucleic acid (DNA) damage.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- DOSE ESCALATION PHASE
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do...
- Patients must have HER2-positive or HER2-expressing tumors determined by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory. Specific...
- Dose Escalation Module 1 and Module 2:
- HER2 1-3+ expression by IHC OR
You likely can't join if
- Patients who have had chemotherapy (including antibody drug therapy) within 4 weeks with the following exceptions: 1 week for weekly paclitaxel; 2...
- Patients who have had radiation therapy within 4 weeks
- Patients who have had a major surgery within 4 weeks
- Patients who are receiving any other investigational agents
- Patients with a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where...
- Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying...
See the full eligibility criteria
Who can join
- DOSE ESCALATION PHASE
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Patients must have HER2-positive or HER2-expressing tumors determined by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory. Specific requirement of HER2 status is outlined below:
- Dose Escalation Module 1 and Module 2:
- HER2 1-3+ expression by IHC OR
- HER2 amplification by next generation sequencing panel (NGS) or in situ hybridization (ISH) OR
- If local testing is not feasible, patients will submit archival tissue for central HER2 testing to determine eligibility. Patients with unknown or negative HER2 testing will not be eligible
- Dose Escalation Module 3:
- HER2 1-2+ expression by IHC OR
- HER2 amplification by next generation sequencing panel (NGS) or in situ hybridization (ISH) OR
- If local testing is not feasible, patients will submit archival tissue for central HER2 testing to determine eligibility. Patients with unknown or negative HER2 testing will not be eligible
- DOSE EXPANSION PHASE
- Patients must have histologically confirmed platinum resistant, high grade serous ovarian carcinoma. Platinum resistant is defined as radiographic progression \< 6 months following the last dose of platinum therapy
- HER2 IHC 1+ per local or central testing
- There must be least one lesion suitable for biopsy without significant risk to the patient
- Patient disease must be evaluable or measurable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Biopsiable lesion cannot be the only RECIST-measurable lesion
- DOSE ESCALATION AND DOSE EXPANSION PHASES
- Patients must have had at least one prior line of cytotoxic chemotherapy
- Patients can have received an unlimited number of additional lines of chemotherapy, targeted therapy, biologic therapy, or hormonal therapy
- Patients must have archival formalin-fixed paraffin-embedded (FFPE) tissue available for central confirmation of HER2 testing
- Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of DS-8201a in combination with olaparib in patients \< 18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 70%)
- Hemoglobin \>= 10.0 g/dL (within 21 days of randomization/enrollment)
- No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment
- Absolute neutrophil count \>= 1,000/mcL (within 21 days of randomization/enrollment)
- No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment
- Platelets \>= 100,000/mcL (within 21 days of randomization/enrollment)
- No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN), (\< 3 x ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline) (within 21 days of randomization/enrollment)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 3 x institutional ULN (within 21 days of...
- Creatinine =\< 1.5 x institutional ULN (within 21 days of randomization/enrollment) OR
- Glomerular filtration rate (GFR) \>= 51 mL/min/1.73 m\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2 (using the Cockcroft-Gault Equation) (within 21 days of...
- Patients must have left ventricular ejection fraction (LVEF) \>= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization/enrollment
- Patients who are human immunodeficiency virus (HIV) positive may participate IF they meet the following eligibility requirements:
- They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective
- They must have an undetectable viral load and a CD4 count \>= 250 cells/uL within 7 days of enrollment
- They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months
- HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with brain metastases should be stable and off steroids and at least 4 weeks from radiation at the time of registration
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- The effects of DS-8201a and olaparib on the developing human fetus are unknown. For this reason and because HER2 antibody conjugated to a topoisomerase 1 inhibitor agents as well as PARP inhibitors are known to be...
- Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood...
- Male people must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to...
- Female people must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration
- Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member...
What rules you out
- Patients who have had chemotherapy (including antibody drug therapy) within 4 weeks with the following exceptions: 1 week for weekly paclitaxel; 2 weeks or five half-lives, whichever is longer, for small-molecule...
- Patients who have had radiation therapy within 4 weeks
- Patients who have had a major surgery within 4 weeks
- Patients who are receiving any other investigational agents
- Patients with a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to DS-8201a, the inactive ingredients in the drug product, olaparib, or severe hypersensitivity to other monoclonal...
- Patients receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A are ineligible. Because the lists of these agents are constantly changing, it is important to regularly...
- Patients with a medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association class IIb to IV), troponin levels...
- Patients with a corrected QT interval (QTc) prolongation to \> 470 ms (females) or \> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)
- Patients with multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors curatively treated
- Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Patients receiving chloroquine or hydroxychloroquine will require a washout period of \>= 14 days to be eligible for the study
- Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade =\< 1 or baseline. people with chronic grade 2 toxicities may be eligible per...
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because DS-8201a is a HER2 antibody conjugated to a topoisomerase 1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown...
- Patients who have received a live, attenuated vaccine within 30 days prior to the first dose of DS-8201a
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.