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Advanced Gastric CancerPhase 2NCT03579784

Biomarker-oriented Study of Durvalumab (MEDI4736) in Combination With Olaparib and Paclitaxel in Gastric Cancer

A Phase 2 study testing Paclitaxel, Olaparib and Durvalumab in people with Advanced Gastric Cancer, run by Do-Youn Oh at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

<Research Hypothesis> The dynamics of immune systems by Olaparib and its changes by combination with immune-oncology agents will be uncovered. The combination of Olaparib with Durvalumab with paclitaxel is tolerable and efficacious in gastric cancer. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
Paclitaxel, Olaparib and Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
26 Nov 2018to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  • Age >= 19 years at time of study entry
  • Histologically proven gastric cancer
  • Unresectable or recurrent
  • Previous exposure to 1 palliative chemotherapy for their unresectable or recurrent cancer (Relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing 5-Fluoropyrimidine monotherapy or 5-fluoropyrimidine and platinum based regimen is considered as first-line therapy)
  • Should have measurable lesion based on RECIST V1.1
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  • Without previous expose to immune-oncology agents including anti-CTLA4, anti-PD1, anti-PDL1, etc
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 , and body weight >30 kg
  • Life expectancy of > 12weeks
  • Adequate normal organ and marrow function as defined below:
  • Haemoglobin ≥ 10.0 g/dL without transfusion within 28 days
  • No features of MDS/AML
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3)
  • Platelet count ≥ 100 x 109/L (>100,000 per mm3)
  • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). <<This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.>>
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5x ULN
  • Serum creatinine CL>51 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
  • Female subjects must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry.
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)Previous enrollment or randomization in the present study
  • Participation in another clinical study with an investigational product during the last 3weeks
  • Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
  • Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug (14 days prior to the first dose of study drug for subjects who have received prior TKIs [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C). (If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period may be required.)
  • Brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases; and stable and off steroids for at least 14 days prior to start of study treatment). Following radiotherapy and/or surgery of the brain metastases subjects must wait 4 weeks following the intervention and before randomisation with imaging to confirm stability.
  • Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction
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  • Current or prior use of immunosuppressive medication within 14days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • -Subjects with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
  • Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • Subjects with vitiligo or alopecia
  • Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Subjects without active disease in the last 5 years may be included but only after consultation with the study physician
  • Subjects with celiac disease controlled by diet alone
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • History of primary immunodeficiency
  • History of allogeneic organ transplant
  • History of hypersensitivity to durvalumab or any excipient
  • History of hypersensitivity to the combination or comparator agent
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • History of leptomeningeal carcinomatosis
  • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
  • Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
  • Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
  • Subjects with uncontrolled seizures.
  • Features of MDS/ AML

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

<Research Hypothesis> The dynamics of immune systems by Olaparib and its changes by combination with immune-oncology agents will be uncovered.

The combination of Olaparib with Durvalumab with paclitaxel is tolerable and efficacious in gastric cancer.

Read more

<Objectives>

Primary Objectives:

To assess the effect of Durvalumab in combination with olaparib and paclitaxel on DCR (Disease control rate) in gastric cancer patients

-Disease control rate (based on RECIST v1.1)

Secondary Objective(s):

  • Efficacy: overall response rate (RECIST 1.1, ir response), progression-free survival, duration of response, overall survival, overall survival at 6 month, overall survival at 1 year, EORTC QLQ-C30,
  • Safety: toxicity (CTCAE V4.1), irAE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Paclitaxel 80 mg/m2 mg iv on D1, D8, D15 Every 4 weeks

  • OlaparibDrug

    Olaparib 150mg bid on D1-28 Every 4 weeks

  • DurvalumabDrug

    Durvalumab 1.5 g iv on D1 Every 4 weeks

Study groups in NCT03579784
Study groupRoleWhat they receive
Durvalumab+Olaparib+PaclitaxelExperimental1. st cycle : Paclitaxel+Olaparib * Olaparib 150mg bid on D1-28 * Paclitaxel 80 mg/m2 mg iv on D1, D8, D15 2. nd cycle and thereafter: Durvalumab+Olaparib+Paclitaxel : * Olaparib 150mg bid on D1-28 * Durvalumab 1.5 g iv on D1 * Paclitaxel 80 mg/m2 mg iv on D1, D8, D15 Every 4 weeks During first 4 weeks, palictaxel/olaparib dual combination will be used. Since 2nd cycle, palictaxel/olaparib/Durvalumab combination will be used.
Receives: Drug: Paclitaxel; Drug: Olaparib; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate

    The percentage of patients who have achieved CR, PR, SD based on RECIST v1.1

    Measured: 8weeks

Secondary outcomes (5)

  1. Overall response rate

    According to RECIST 1.1, ir response criteria

    Measured: 8weeks

  2. Progression-free survival

    Time from randomization until disease progression or death

    Measured: 8weeks

  3. Duration of response

    Time from documentation of tumor response to disease progression

    Measured: 8weeks

  4. Overall survival

    Time from randomization until death from any cause

    Measured: 8weeks

  5. Safety and tolerability as measured by number and grade of toxicity events

    Overall Safety Profile by CTCAE V4.1, irAE

    Measured: 2weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2018
  2. Study start26 Nov 2018
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03579784
Sponsor's protocol ID
ESR-15-11655
Status last verified
Apr 2024
First submitted
19 Jun 2018
Last updated
19 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Olaparib and Durvalumab in people with Advanced Gastric Cancer, run by Do-Youn Oh at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (time frame: 8weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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