Back to results

PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

Primary Purpose

Advanced Gastric Adenocarcinoma

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GSK2636771

Paclitaxel

About this trial

This is an interventional treatment trial for Advanced Gastric Adenocarcinoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma
Has a PTEN-deficient tumor as documented from archival or fresh (from biopsy) tumor tissue or has shown genomic alterations in PI3K pathway genes (PIK3CB, PI3KR1, PTEN, etc.) as assessed in a local laboratory.
Has had no prior taxane exposure (preferred) or at least 6 months since last taxane exposure.
Eastern Cooperative Oncology Group performance status of 0 or 1
measurable or evaluable disease as determined by RECIST 1.1.
Is able to swallow and retain orally administered medication
adequate baseline organ function

Exclusion criteria

prior treatment with any AKT, mammalian target of rapamycin (mTOR) inhibitors or PI3K pathway inhibitors
Has any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or Grade 2 anemia (if hemoglobin is ≥9.0 g/dL)
Has CNS metastases
Has a QTc interval >450 msec or QTc >480 msec for subjects with bundle branch block (BBB)
Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2636771 or hypersensitivity to drug formulated in polyoxyl 35 castor oil, NF such as paclitaxel.

Sites / Locations

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel & GSK2636771

Arm Description

Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily) in combination with a fixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)

Outcomes

Primary Outcome Measures

Recommended Phase II dose for phase 1

Progression-free survival for phase 2

Secondary Outcome Measures

Dose limiting toxicity for phase 1

Full Information

NCT ID

NCT02615730

First Posted

November 24, 2015

Last Updated

April 21, 2021

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02615730

Brief Title

PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

Official Title

A Phase Ib/IIa, Open-Label, Dose Finding Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of PI3Kβ Selective Inhibitor (GSK2636771) Administered in Combination With Paclitaxel in Advanced Gastric Adenocarcinoma Having Alterations in PI3K Pathway Genes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

March 31, 2021 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of GSK2636771 administered in combination with paclitaxel. The Dose Expansion Phase (Phase IIa) will further evaluate the safety and clinical activity of the RP2D as determined in the Dose Escalation Phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Gastric Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel & GSK2636771

Arm Type

Experimental

Arm Description

Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily) in combination with a fixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)

Intervention Type

Drug

Intervention Name(s)

GSK2636771

Intervention Description

Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily)

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

fixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)

Primary Outcome Measure Information:

Title

Recommended Phase II dose for phase 1

Time Frame

4 weeks

Title

Progression-free survival for phase 2

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Dose limiting toxicity for phase 1

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma Has a PTEN-deficient tumor as documented from archival or fresh (from biopsy) tumor tissue or has shown genomic alterations in PI3K pathway genes (PIK3CB, PI3KR1, PTEN, etc.) as assessed in a local laboratory. Has had no prior taxane exposure (preferred) or at least 6 months since last taxane exposure. Eastern Cooperative Oncology Group performance status of 0 or 1 measurable or evaluable disease as determined by RECIST 1.1. Is able to swallow and retain orally administered medication adequate baseline organ function Exclusion criteria prior treatment with any AKT, mammalian target of rapamycin (mTOR) inhibitors or PI3K pathway inhibitors Has any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or Grade 2 anemia (if hemoglobin is ≥9.0 g/dL) Has CNS metastases Has a QTc interval >450 msec or QTc >480 msec for subjects with bundle branch block (BBB) Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2636771 or hypersensitivity to drug formulated in polyoxyl 35 castor oil, NF such as paclitaxel.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sun Young Rha

Organizational Affiliation

Yonsei Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

We'll reach out to this number within 24 hrs