PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT02615730 |
Recruitment Status :
Completed
First Posted : November 26, 2015
Last Update Posted : April 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Advanced Gastric Adenocarcinoma | Drug: GSK2636771 Drug: Paclitaxel | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | February 2016 |
Actual Primary Completion Date : | March 31, 2021 |
Actual Study Completion Date : | March 31, 2021 |
Arm | Intervention/treatment |
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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)
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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) |
- Recommended Phase II dose for phase 1 [ Time Frame: 4 weeks ]
- Progression-free survival for phase 2 [ Time Frame: 6 weeks ]
- Dose limiting toxicity for phase 1 [ Time Frame: 28 days ]
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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615730
Korea, Republic of | |
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center | |
Seoul, Korea, Republic of, 120-752 |
Principal Investigator: | Sun Young Rha | Yonsei Cancer Center |
Responsible Party: | Sun Young Rha, Professor, Yonsei University |
ClinicalTrials.gov Identifier: | NCT02615730 |
Other Study ID Numbers: |
4-2015-0204 |
First Posted: | November 26, 2015 Key Record Dates |
Last Update Posted: | April 22, 2021 |
Last Verified: | April 2021 |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Paclitaxel GSK2636771 Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors |