Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

  • STATUS
    Recruiting
  • End date
    Jul 12, 2024
  • participants needed
    36
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 12 March 2022

Summary

The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC).

Details
Condition Advanced Gastric Adenocarcinoma
Treatment Paclitaxel, Pembrolizumab, olaparib
Clinical Study IdentifierNCT04209686
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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