Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02574663
Other study ID # TGR-1202-102 (RM-404)
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 11, 2015
Est. completion date August 2018

Study information

Verified date October 2019
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
TGR-1202
TGR-1202 oral daily dose
nab-paclitaxel + gemcitabine
IV infusion
Oxaliplatin + Folinic acid + Fluorouracil
IV infusion
Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab
IV Infusion

Locations

Country Name City State
United States TG Therapeutics Trial Site Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
TG Therapeutics, Inc. SCRI Development Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall Response Rate 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. Up to 1 year
Secondary Duration of Response 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. Up to 1 year
Secondary Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax). 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. At selected timepoints up through 6 months
Secondary Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax). At selected timepoints up through 6 months
Secondary Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC) At selected timepoints up through 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A