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PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02615730
Collaborator
(none)
42
Enrollment
1
Location
1
Arm
61.9
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paclitaxel & GSK2636771

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)

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

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

Outcome Measures

Primary Outcome Measures

  1. Recommended Phase II dose for phase 1 [4 weeks]

  2. Progression-free survival for phase 2 [6 weeks]

Secondary Outcome Measures

  1. Dose limiting toxicity for phase 1 [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

  1. histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma

  2. 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.

  3. Has had no prior taxane exposure (preferred) or at least 6 months since last taxane exposure.

  4. Eastern Cooperative Oncology Group performance status of 0 or 1

  5. measurable or evaluable disease as determined by RECIST 1.1.

  6. Is able to swallow and retain orally administered medication

  7. adequate baseline organ function

Exclusion criteria

  1. prior treatment with any AKT, mammalian target of rapamycin (mTOR) inhibitors or PI3K pathway inhibitors

  2. 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)

  3. Has CNS metastases

  4. Has a QTc interval >450 msec or QTc >480 msec for subjects with bundle branch block (BBB)

  5. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Severance Hospital, Yonsei University Health System, Yonsei Cancer Center Seoul Korea, Republic of 120-752

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Sun Young Rha, Yonsei Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Young Rha, Professor, Yonsei University
ClinicalTrials.gov Identifier:
NCT02615730
Other Study ID Numbers:
  • 4-2015-0204
First Posted:
Nov 26, 2015
Last Update Posted:
Apr 22, 2021
Last Verified:
Apr 1, 2021
Additional relevant MeSH terms:
Adenocarcinoma
Paclitaxel
GSK2636771

Study Results

No Results Posted as of Apr 22, 2021