Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT04209686|
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : March 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastric Adenocarcinoma||Drug: Paclitaxel Drug: Olaparib Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma|
|Actual Study Start Date :||July 31, 2020|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2024|
Experimental: All Participants
All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.
Other Name: Taxol
Other Name: Lynparza
Other Name: MK-3475; Keytruda
- Overall survival (OS) [ Time Frame: 4 years ]OS will be measured from the time of drug administration at Cycle 1, Day 1 until death due to any cause. All subjects who receive at least one dose of the 3-drug combination will be included. Subjects who discontinue treatment prior to Cycle 2 will not be included in the analysis. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which that patient was known to be alive. Estimation based on the Kaplan-Meier curve.
- The number of patients experiencing study drug-related toxicities. [ Time Frame: 4 years ]Number of patients experiencing study drug-related adverse adverse events Grade 3 or higher as defined by CTCAE v5.0.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Must have advanced gastric or gastroesophageal cancer.
- Must have received and progressed on only one prior line of systemic therapy for advanced disease.
- Must have the presence of measurable lesion.
- Must agree to have a biopsy.
- Life expectancy of greater than 3 months.
- Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
- Woman of childbearing potential must have a negative pregnancy test.
- Must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Require any antineoplastic therapy.
- Require any other form of systemic or localized antineoplastic therapy.
- Has received prior therapy with paclitaxel or PARP inhibitor. Previous paclitaxel may be allowed if no progression on or within 6 months of receiving this drug.
- Hypersensitivity reaction to any paclitaxel, pembrolizumab or related compounds and/or to any of the components.
- Allergy to dexamethasone, diphenhydramine and famotidine.
- Is taking a moderate or strong CYP3A inhibitor.
- Has uncontrolled intercurrent acute or chronic medical illness.
- Has a known additional malignancy that is progressing and has required active treatment within the past 1 year.
- Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to study treatment.
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is currently or has participated in another investigational study within 4 weeks prior to receiving study drug.
- Has an active known or suspected autoimmune disease.
- Has a diagnosis of immunodeficiency.
- Prior tissue or organ allograft or allogeneic bone marrow transplantation.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. .
- Requires daily supplemental oxygen.
- History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
- Infection with HIV or hepatitis B or C at screening.
- Has uncontrolled infection requiring systemic therapy..
- Subjects unable to undergo venipuncture and/or tolerate venous access.
- Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
- Woman who are pregnant or breastfeeding.
- A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to study drug initiation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209686
|Contact: Trish Brothers, RN||410-614-3644||GIClinicalTrials@jhmi.edu|
|Contact: Sheila Linden, RNemail@example.com|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Trish Brothers, RN 410-614-3644 GIClinicalTrials@jhmi.edu|
|Contact: Sheila Linden, RN 410-614-4397 firstname.lastname@example.org|
|Principal Investigator:||Katherine Bever, MD||Johns Hopkins Medical Institution|
|Responsible Party:||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Other Study ID Numbers:||
IRB00209006 ( Other Identifier: Johns Hopkins Medical Institution )
|First Posted:||December 24, 2019 Key Record Dates|
|Last Update Posted:||March 8, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors