NCT02574663

Brief Summary

This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1 pancreatic-cancer

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2019

Enrollment Period

2.9 years

First QC Date

October 1, 2015

Last Update Submit

October 1, 2019

Conditions

Pancreatic CancerColorectal CancerRectal CancerGastric CancerEsophageal CancerGastrointestinal Stromal Tumor (GIST)

Outcome Measures

Primary Outcomes (1)

  • Adverse events as a measure of safety and tolerability of TGR-1202 as a single agent and in combination in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.

    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.

    Up to 28 days after the last patient enrolled

Secondary Outcomes (5)

  • Overall Response Rate

    Up to 1 year

  • Duration of Response

    Up to 1 year

  • Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax).

    At selected timepoints up through 6 months

  • Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).

    At selected timepoints up through 6 months

  • Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)

    At selected timepoints up through 6 months

Study Arms (4)

TGR-1202

EXPERIMENTAL

TGR-1202 daily dose

Drug: TGR-1202

TGR-1202 + nab-paclitaxel + gemcitabine

EXPERIMENTAL

TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion

Drug: TGR-1202Drug: nab-paclitaxel + gemcitabine

TGR-1202 + FOLFOX

EXPERIMENTAL

TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen)

Drug: TGR-1202Drug: Oxaliplatin + Folinic acid + Fluorouracil

TGR-1202 + FOLFOX + Bevacizumab

EXPERIMENTAL

TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) + bevacizumab IV infusion

Drug: TGR-1202Drug: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab

Interventions

TGR-1202DRUG

TGR-1202 oral daily dose

TGR-1202TGR-1202 + FOLFOXTGR-1202 + FOLFOX + BevacizumabTGR-1202 + nab-paclitaxel + gemcitabine
nab-paclitaxel + gemcitabineDRUG

IV infusion

Also known as: Abraxane (nab-paclitaxel) + Gemzar (gemcitabine)
TGR-1202 + nab-paclitaxel + gemcitabine
Oxaliplatin + Folinic acid + FluorouracilDRUG

IV infusion

Also known as: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil)
TGR-1202 + FOLFOX
Oxaliplatin + Folinic acid + Fluorouracil + BevacizumabDRUG

IV Infusion

Also known as: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)
TGR-1202 + FOLFOX + Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed:
  • adenocarcinoma of the pancreas (pancreatic cancer)
  • adenocarcinoma of the colon or rectum (colorectal cancer)
  • adenocarcinoma of the gastric (gastric cancer)
  • esophageal cancer
  • gastrointestinal stromal tumor (GIST)
  • Relapsed or refractory disease
  • Measurable lesion by RECIST 1.1

You may not qualify if:

  • Known Hepatitis B, C or HIV infection
  • Previous therapy with any drug that inhibits the PI3K pathway
  • Anti-tumor therapy within 21 days of study Day 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TG Therapeutics Trial Site

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsColorectal NeoplasmsRectal NeoplasmsStomach NeoplasmsEsophageal NeoplasmsGastrointestinal Stromal Tumors

Interventions

umbralisib130-nm albumin-bound paclitaxelGemcitabineAlbumin-Bound PaclitaxelOxaliplatinLeucovorinFluorouracilBevacizumab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsCoordination ComplexesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesUracilPyrimidinonesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulins

Study Officials

  • Johanna Bendell, MD

    Sarah Cannon Research Instititue (SCRI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 14, 2015

Study Start

September 11, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 2, 2019

Record last verified: 2019-10

Locations

US(1)