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Small Molecule Inhibitor

TRK-950 Combinations for Ovarian Cancer

Phase 1
Recruiting
Research Sponsored by Toray Industries, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Arm G. Renal Cell Carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab for use in a fourth line or later treatment
Arm K. (US Sites Only). Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 2 prior treatment lines who have recurred > 6 months after most recent platinum-based chemotherapy and who are eligible for gemcitabine, carboplatin, and Bevacizumab as standard of care for dosing of TRK-950(Lower-dose)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing the safety and ideal dosage of the drug TRK-950 when used in combination with various other cancer treatments.

Who is the study for?
This trial is for adults with various advanced solid tumors, including specific types of ovarian, colorectal, and renal cancers. Participants must have measurable tumors and meet criteria for certain treatment regimens based on their cancer type and previous treatments. Pregnant women or those with recent therapies or serious infections are excluded.Check my eligibility
What is being tested?
The study tests the safety and optimal dose of TRK-950 in combination with other cancer drugs like FOLFIRI, Gemcitabine/Cisplatin, Ramucirumab/Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), among others. It aims to find effective treatments tailored to different tumor types.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in organs due to PD1 inhibitors; chemotherapy-related issues like nausea, fatigue; skin reactions from Imiquimod Cream; and increased risk of bleeding or hypertension from Bevacizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have renal cell carcinoma and have never been treated with Bevacizumab.
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I have ovarian, peritoneal, or fallopian tube cancer, treated with platinum less than 3 times and it returned more than 6 months after the last treatment.
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My cancer type and history require specific treatments.
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I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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My tumor can be measured using scans or special tools.
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I have colorectal cancer and have never been treated with Irinotecan or FOLFIRI.
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I have cholangiocarcinoma or bladder cancer and haven't been treated with Gemcitabine.
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I meet the specific requirements for a treatment group based on my past treatments and eligibility for standard care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood pressure
Frequency of patients experiencing adverse events of special interest (AESIs)
Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0
+9 more
Secondary outcome measures
Disease Control Rate (DCR)
Overall response rate (ORR)
Plasma concentration of Carboplatin for the first six patients in Arm K
+7 more

Trial Design

15Treatment groups
Experimental Treatment
Group I: Arm T: TRK-950 + PaclitaxelExperimental Treatment2 Interventions
Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1, 8 and 15 of each cycle, Paclitaxel will be dosed on IV
Group II: Arm S: TRK-950 + Carboplatin / PLD/ BevacizumabExperimental Treatment4 Interventions
Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer Treatment Phase: TRK-950 will be administered IV on days 1 and 15 of a 28-day cycle. Carboplatin will be administered as an intravenous infusion on day 1. On day 1, following the administration of Carboplatin, PLD will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. On days 1 and 15, TRK-950 will be administered IV after the Bevacizumab infusion. • Maintenance Phase: After 6 cycles of chemotherapy, the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Following the Bevacizumab administration, TRK-950 will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease.
Group III: Arm R: TRK-950 + BevacizumabExperimental Treatment2 Interventions
Renal cell carcinoma cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. Bevacizumab will be dosed as IV on Day 1 and 15 of each cycle. On days that TRK-950 and Bevacizumab are both dosed, Bevacizumab will be dosed first.
Group IV: Arm Q: TRK-950 + Ramucirumab/PaclitaxelExperimental Treatment3 Interventions
Gastric cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. On days 1 and 15, ramucirumab will be administered IV. Paclitaxel will be dosed on days 1, 8 and 15, after ramucirumab on days 1 and 15, before TRK-950 on day 8.
Group V: Arm O: TRK-950 + PLDExperimental Treatment2 Interventions
Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. PLD will be dosed as IV on Day 1 of each cycle. On days that TRK-950 and PLD are both dosed, PLD will be dosed first.
Group VI: Arm K: TRK-950 + Gemcitabine / Carboplatin / BevacizumabExperimental Treatment4 Interventions
Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. On all dosing days, TRK-950 will be administered IV after the relevant combination regimen is dosed. Gemcitabine will be administered as an intravenous infusion on days 1 and 8. On day 1, following the administration of Gemcitabine, Carboplatin will be administered as an intravenous infusion. Also on Day 1 of each cycle, Bevacizumab will be administered IV next. After 6 cycles of chemotherapy the patient will be transitioned to maintenance treatment. On Day 1 of each maintenance cycle, Bevacizumab will be administered IV. Maintenance treatment will be continued as long as there is no evidence of progressive disease.
Group VII: Arm J: TRK-950 + FOLFIRIExperimental Treatment4 Interventions
Colorectal Cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.
Group VIII: Arm H: TRK-950 + PD1 inhibitorsExperimental Treatment3 Interventions
•Melanoma H-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. H-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.
Group IX: Arm G: TRK-950 + BevacizumabExperimental Treatment2 Interventions
Renal Cell Carcinoma TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Bevacizumab will be administered as an IV infusion.
Group X: Arm F: TRK-950 + Imiquimod CreamExperimental Treatment2 Interventions
Palpable subcutaneous malignant lesions TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. Imiquimod cream is to be applied 5 of 7 days in a row with 2 days rest for a maximum of 2 cycles (total 6 weeks).
Group XI: Arm E: TRK-950 + PD1 inhibitorsExperimental Treatment3 Interventions
•Solid Tumors E-1: TRK-950 + Nivolumab •TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Nivolumab will be administered as an IV infusion. E-2: TRK-950 + Pembrolizumab •TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on day 1, Pembrolizumab will be administered as an IV infusion.
Group XII: Arm D: TRK-950 + Ramucirumab/PaclitaxelExperimental Treatment3 Interventions
Gastric Cancer TRK-950 will be administered IV on days 1, 8, 15, and 22 of a 28-day cycle. After the administration of TRK-950 on days 1 and 15, Ramucirumab will be administered as an IV infusion. Paclitaxel will be dosed on days 1, 8 and 15, after the Ramucirumab on days 1 and 15 and after the TRK-950 on day 8.
Group XIII: Arm C: TRK-950 + Gemcitabine/CarboplatinExperimental Treatment3 Interventions
Ovarian Cancer TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Gemcitabine will be administered as an intravenous infusion. On day 1, following the administration of TRK-950 and Gemcitabine, Carboplatin will be administered IV.
Group XIV: Arm B: TRK-950 + Gemcitabine/CisplatinExperimental Treatment3 Interventions
Cholangiocarcinoma or Bladder Cancer TRK-950 will be administered IV on days 1, 8 and 15 of a 21-day cycle. After the administration of TRK-950 on days 1 and 8, Cisplatin will be administered by infusion. Then, Gemcitabine will be administered as an IV infusion.
Group XV: Arm A: TRK-950 + FOLFIRIExperimental Treatment4 Interventions
Colorectal Cancer TRK-950 will be administered intravenously (IV) on days 1, 8, 15, and 22 of a 28-day cycle. On days 1 and 15 Irinotecan will be administered IV. Leucovorin will be infused to match the duration of the irinotecan infusion. 5-FU will be administered as IV bolus, followed by TRK-950 administration. After the TRK-950, 5-FU will be administered by a continuous infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 4
~2680
Bevacizumab
2013
Completed Phase 4
~5280
Gemcitabine
2017
Completed Phase 3
~2070
Nivolumab
2014
Completed Phase 3
~4750
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Ramucirumab
2017
Completed Phase 3
~5050
Imiquimod Cream
2005
N/A
~90
PLD
2015
Completed Phase 3
~1420
Leucovorin
2005
Completed Phase 4
~5730
5-FU
2014
Completed Phase 3
~3420
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 2
~2010
TRK-950
2017
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Toray Industries, IncLead Sponsor
21 Previous Clinical Trials
2,213 Total Patients Enrolled

Media Library

TRK-950 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03872947 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What implications does TRK-950 have for patient safety?

"Limited data exists to evaluate the safety and efficacy of TRK-950, leading us at Power to rate it a 1 on our scale."

Answered by AI

What is the primary application of TRK-950?

"TRK-950 is an accepted treatment for metastatic cutaneous squamous cell carcinoma. It has also been utilized to combat malignant neoplasms, melanoma, and macrocytic anemia."

Answered by AI

How many locales are responsible for the oversight of this clinical exploration?

"The study is recruiting from 15 total sites, including USC Norris Comprehensive Cancer Center in Los Angeles, California; Virginia Cancer Specialists, PC in Leesburg, Virginia; and HonorHealth Research Institute in Scottsdale, Arizona."

Answered by AI

Have any other research endeavors included TRK-950 in their methodology?

"TRK-950 was first investigated in 1997 at City of Hope Comprehensive Cancer Center. 4736 trials have been completed since then, with 3613 currently recruiting participants primarily in Los Angeles, California."

Answered by AI

What is the enrollment limit for this research study?

"Affirmative. According to the medical trial details listed on clinicaltrials.gov, enrolment is open for this study; it was initially posted in April of 2019 and most recently updated in October 2022. 169 participants are required from 13 separate sites."

Answered by AI

Does this medical experiment currently have open enrollment?

"Per the information stored on clinicaltrials.gov, this study is currently recruiting participants. It was originally posted in April of 2019 and underwent its latest update in October 2022."

Answered by AI

Who else is applying?

How old are they?
65+
What site did they apply to?
USC Norris Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Washington
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I had right kidney removed when was in hospital they oxy me out horrible withdrawls will never go nack.
PatientReceived 2+ prior treatments
~29 spots leftby Mar 2025