Pancreatic CancerPhase 1NCT02574663
TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
A Phase 1 study testing TGR-1202, nab-paclitaxel + gemcitabine and Oxaliplatin + Folinic acid + Fluorouracil in people with Pancreatic Cancer and Colorectal Cancer, run by TG Therapeutics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Colorectal Cancer, Rectal Cancer
- What is being tested?
- TGR-1202, nab-paclitaxel + gemcitabine and Oxaliplatin + Folinic acid + Fluorouracil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2015to Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
TG Therapeutics Trial Site
Nashville, Tennessee, 37203
About this study
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
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Colorectal Cancer, Rectal Cancer, Gastric Cancer, Esophageal Cancer, Gastrointestinal Stromal Tumor (GIST)
- Being tested
- TGR-1202, nab-paclitaxel + gemcitabine, Oxaliplatin + Folinic acid + Fluorouracil, Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab
- Medical subject headings
- Pancreatic Neoplasms, Colorectal Neoplasms, Rectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGR-1202Drug
TGR-1202 oral daily dose
nab-paclitaxel + gemcitabineDrug
Also called Abraxane (nab-paclitaxel) + Gemzar (gemcitabine)
IV infusion
Oxaliplatin + Folinic acid + FluorouracilDrug
Also called Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil)
IV infusion
Oxaliplatin + Folinic acid + Fluorouracil + BevacizumabDrug
Also called Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| TGR-1202 | Experimental | TGR-1202 daily dose Receives: Drug: TGR-1202 |
| TGR-1202 + nab-paclitaxel + gemcitabine | Experimental | TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion Receives: Drug: TGR-1202; Drug: 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) Receives: Drug: TGR-1202; Drug: 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 Receives: Drug: TGR-1202; Drug: Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days after the last patient enrolled
Secondary outcomes (5)
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: At selected timepoints up through 6 months
Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).
Measured: At selected timepoints up through 6 months
Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)
Measured: At selected timepoints up through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study start11 Sep 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Responsible party
- Sponsor
- Investigators
- Johanna Bendell, MD, Study chair, Sarah Cannon Research Instititue (SCRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574663
- Sponsor's protocol ID
- TGR-1202-102 (RM-404)
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2015
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02574663
- Acronym / sponsor ID
- TGR-1202-102 (RM-404)
- Conditions
- Pancreatic Cancer, Colorectal Cancer, Rectal Cancer, Gastric Cancer, Esophageal Cancer, Gastrointestinal Stromal Tumor (GIST)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Study start
- 11 Sep 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TGR-1202 | Experimental | Drug: TGR-1202TGR-1202 daily dose |
| TGR-1202 + nab-paclitaxel + gemcitabine | Experimental | Drug: TGR-1202, Drug: nab-paclitaxel + gemcitabineTGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion |
| TGR-1202 + FOLFOX | Experimental | Drug: TGR-1202, Drug: Oxaliplatin + Folinic acid + FluorouracilTGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen) |
| TGR-1202 + FOLFOX + Bevacizumab | Experimental | Drug: TGR-1202, Drug: Oxaliplatin + Folinic acid + Fluorouracil + BevacizumabTGR-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed:
- Relapsed or refractory disease
- Measurable lesion by RECIST 1.1
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGR-1202TGR-1202 oral daily dose | Drug | TGR-1202, TGR-1202 + FOLFOX, TGR-1202 + FOLFOX + Bevacizumab, TGR-1202 + nab-paclitaxel + gemcitabine |
| nab-paclitaxel + gemcitabineAlso: Abraxane (nab-paclitaxel) + Gemzar (gemcitabine)IV infusion | Drug | TGR-1202 + nab-paclitaxel + gemcitabine |
| Oxaliplatin + Folinic acid + FluorouracilAlso: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil)IV infusion | Drug | TGR-1202 + FOLFOX |
| Oxaliplatin + Folinic acid + Fluorouracil + BevacizumabAlso: Eloxatin (Oxaliplatin) + Leucovorin (Folinic acid) + 5-FU (Fluorouracil) + Avastin (Bevacizumab)IV Infusion | Drug | TGR-1202 + FOLFOX + Bevacizumab |
Primary outcome
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.
5 secondary outcomes
Overall Response Rate
Time frame: Up to 1 year
Duration of Response
Time frame: Up to 1 year
Pharmacokinetic (PK) profile of TGR-1202. Peak Plasma Concentration (Cmax).
Time frame: At selected timepoints up through 6 months
Pharmacokinetic (PK) profile of TGR-1202. Time to Peak Plasma Concentration (Tmax).
Time frame: At selected timepoints up through 6 months
Pharmacokinetic (PK) profile of TGR-1202. Area under the plasma concentration versus time curve (AUC)
Time frame: At selected timepoints up through 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Bendell, MD study chair
Sarah Cannon Research Instititue (SCRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TGR-1202, nab-paclitaxel + gemcitabine and Oxaliplatin + Folinic acid + Fluorouracil in people with Pancreatic Cancer and Colorectal Cancer, run by TG Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.