Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04209686
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    1. Patients will receive treatment on Day 1 and 8 starting with cycle 2. 2. Paclitaxel (80 mg) will be administered IV on days 1 and 8 starting with cycle 2 (every 21 days). 3. Drug - Paclitaxel - 80mg IV
  • Olaparib — DRUG
    1. Olaparib will be taken by mouth daily for 3 weeks (every 21 days). 2. Drug - 100 mg or 300mg
  • Pembrolizumab — DRUG
    1. Patients will receive treatment every 21 days. 2. Pembrolizumab (200 mg) will be administered IV on day 1 (every 21 days). 3. Drug - 200mg IV

Study Details

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).

Key Dates

Start date
Jul 31, 2020
Status verified
Dec 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 - Measurable Disease
    All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.
  • Experimental: Arm 2: Cohort 2-Unmeasurable Disease
    All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-

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By research site
Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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