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

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ClinicalTrials.gov Identifier: NCT02574663
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
TG Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Colorectal Cancer Rectal Cancer Gastric Cancer Esophageal Cancer Gastrointestinal Stromal Tumor (GIST) Drug: TGR-1202 Drug: nab-paclitaxel + gemcitabine Drug: Oxaliplatin + Folinic acid + Fluorouracil Drug: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab Phase 1

Detailed Description:
TGR-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum, gastric and GE junction cancer, and GI Stromal Tumor (GIST) who have relapsed from or are refractory to prior treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
Actual Study Start Date : September 11, 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018


Arm Intervention/treatment
Experimental: TGR-1202
TGR-1202 daily dose
Drug: TGR-1202
TGR-1202 oral daily dose

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

Drug: nab-paclitaxel + gemcitabine
IV infusion
Other Name: Abraxane (nab-paclitaxel) + Gemzar (gemcitabine)

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)
Drug: TGR-1202
TGR-1202 oral daily dose

Drug: Oxaliplatin + Folinic acid + Fluorouracil
IV infusion
Other Name: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil)

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
Drug: TGR-1202
TGR-1202 oral daily dose

Drug: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab
IV Infusion
Other Name: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)




Primary Outcome Measures :
  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. [ Time Frame: Up to 28 days after the last patient enrolled ]
    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 1 year ]
    Overall response rate with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.

  2. Duration of Response [ Time Frame: Up to 1 year ]
    Duration of response with TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.

  3. Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax). [ Time Frame: At selected timepoints up through 6 months ]
    This endpoint will measure the plasma PK profile of TGR-1202 as a single agent and in combination with nab-paclitaxel + gemcitabine, or with oxaliplatin + leucovorin + 5-FU (FOLFOX) or with FOLFOX + bevacizumab.

  4. Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax). [ Time Frame: At selected timepoints up through 6 months ]
  5. Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC) [ Time Frame: At selected timepoints up through 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed:

    1. adenocarcinoma of the pancreas (pancreatic cancer)
    2. adenocarcinoma of the colon or rectum (colorectal cancer)
    3. adenocarcinoma of the gastric (gastric cancer)
    4. esophageal cancer
    5. gastrointestinal stromal tumor (GIST)
  • Relapsed or refractory disease
  • Measurable lesion by RECIST 1.1

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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): NCT02574663


Locations
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United States, Tennessee
TG Therapeutics Trial Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
TG Therapeutics, Inc.
SCRI Development Innovations, LLC
Investigators
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Study Chair: Johanna Bendell, MD Sarah Cannon Research Instititue (SCRI)

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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02574663     History of Changes
Other Study ID Numbers: TGR-1202-102 (RM-404)
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Leucovorin
Folic Acid
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Oxaliplatin
Fluorouracil
Levoleucovorin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors