TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
TG Therapeutics, Inc.
Study ID
NCT02574663
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Oct 14, 2015
Start date
Sep 11, 2015
Status verified
Oct 2019
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018

Study Design

Enrollment
66 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TGR-1202
    TGR-1202 daily dose
  • Experimental: TGR-1202 + nab-paclitaxel + gemcitabine
    TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion
  • Experimental: TGR-1202 + FOLFOX
    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)
  • Experimental: TGR-1202 + FOLFOX + Bevacizumab
    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

Primary Outcome Measure

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. [ Time Frame: Up to 28 days after the last patient enrolled ]

Locations (1)

FacilityCityStateZIPSite coordinators
TG Therapeutics Trial SiteNashvilleTennessee37203-

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By specialty
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By research site
TG Therapeutics Trial Site· Nashville, TN

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