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A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03872947
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Toray Industries, Inc

Brief Summary:
The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream for selected advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Colon Cancer Cholangiocarcinoma Bladder Cancer Ovarian Cancer Gastric Cancer Palpable Subcutaneous Malignant Lesions Biological: TRK-950 Drug: Irinotecan Drug: Leucovorin Drug: 5-FU Drug: Gemcitabine Drug: Cisplatin Drug: Carboplatin Biological: Ramucirumab Drug: Paclitaxel Biological: Nivolumab Biological: Pembrolizumab Drug: Imiquimod Cream Phase 1

Detailed Description:
This study is an open-label, Phase 1b study evaluating TRK-950 in combination with 1) FOLFIRI or 2) Gemcitabine / Cisplatin or 3) Gemcitabine / Carboplatin or 4) Ramucirumab/Paclitaxel or 5) PD1 inhibitors (Nivolumab or Pembrolizumab) or 6) Imiquimod Cream for subcutaneous lesions in Patients with Selected Advanced Solid Tumors. The objectives of this study are to determine the safety, tolerability, MTD, recommended Phase 2 dose (RP2D), PK, and preliminary anti-tumor activity of TRK-950 when used in combination with other treatment regimens.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors
Actual Study Start Date : April 26, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: Arm A: TRK-950 + FOLFIRI
  • Colon Cancer
  • TRK-950 will be administered intravenously 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.
Biological: TRK-950
Intravenously over 60 minutes

Drug: Irinotecan
Intravenously over 30 - 90 minutes

Drug: Leucovorin
Intravenously over 30 - 90 minutes

Drug: 5-FU
Intravenously bolus and intravenously over two days

Experimental: Arm B: TRK-950 + Gemcitabine/Cisplatin
  • Cholangiocarcinoma or Bladder Cancer
  • TRK-950 will be administered intravenously 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 intravenous infusion.
Biological: TRK-950
Intravenously over 60 minutes

Drug: Gemcitabine
Intravenously over 30 minutes

Drug: Cisplatin
Intravenously over 60 minutes

Experimental: Arm C: TRK-950 + Gemcitabine/Carboplatin
  • Ovarian Cancer
  • TRK-950 will be administered intravenously 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 intravenously.
Biological: TRK-950
Intravenously over 60 minutes

Drug: Gemcitabine
Intravenously over 30 minutes

Drug: Carboplatin
Intravenously

Experimental: Arm D: TRK-950 + Ramucirumab/Paclitaxel
  • Gastric Cancer
  • TRK-950 will be administered intravenously 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.
Biological: TRK-950
Intravenously over 60 minutes

Biological: Ramucirumab
Intravenously over 60 minutes

Drug: Paclitaxel
Intravenously

Experimental: Arm E: TRK-950 + PD1 inhibitors

•Solid Tumors

E-1: TRK-950 + Nivolumab

•TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle. On Day 1 and 15 after the administration of TRK-950, Nivolumab will be administered as an IV infusion.

E-2: TRK-950 + Pembrolizumab

•TRK-950 will be administered intravenously 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.

Biological: TRK-950
Intravenously over 60 minutes

Biological: Nivolumab
Intravenously over 30 minutes

Biological: Pembrolizumab
Intravenously over 30 minutes

Experimental: Arm F: TRK-950 + Imiquimod Cream
  • Palpable subcutaneous malignant lesions
  • TRK-950 will be administered intravenously 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).
Biological: TRK-950
Intravenously over 60 minutes

Drug: Imiquimod Cream
Topically




Primary Outcome Measures :
  1. Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: through study completion, an average of 1 year ]
  2. Blood pressure [ Time Frame: through study completion, an average of 1 year ]
    mmHg

  3. Heart rate [ Time Frame: through study completion, an average of 1 year ]
    bpm

  4. Respiratory rate [ Time Frame: through study completion, an average of 1 year ]
    bpm

  5. Temperature [ Time Frame: through study completion, an average of 1 year ]
    °F or °C

  6. Weight [ Time Frame: through study completion, an average of 1 year ]
    lbs/kg

  7. Height [ Time Frame: through study completion, an average of 1 year ]
    inches/cm

  8. Performance status using Karnofsky performance status criteria [ Time Frame: through study completion, an average of 1 year ]
  9. QTc interval determined from 12-lead Electrocardiogram [ Time Frame: through study completion, an average of 1 year ]
    msec

  10. QRS interval determined from 12-lead Electrocardiogram [ Time Frame: through study completion, an average of 1 year ]
    msec

  11. Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry) [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: through study completion, an average of 1 year ]
  2. Disease Control Rate (DCR) [ Time Frame: through study completion, an average of 1 year ]
  3. Plasma concentration of TRK-950 [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 solid malignancy for which the following treatment regimens are warranted:

    • A. Colon Cancer:FOLFIRI as standard of care
    • B. Cholangiocarcinoma, Bladder Cancer: Gemcitabine / Cisplatin as standard of care
    • C. Ovarian Cancer who have relapsed at least 6 or more months after completion of a previous platinum-based therapy: Gemcitabine / Carboplatin as standard of care
    • D. Gastric Cancer: Ramucirumab / Paclitaxel as standard of care
    • E. Solid Tumors: Eligible for PD1 Inhibitor (nivolumab or pembrolizumab) monotherapy as standard of care according to the approved drug label by the relevant regulatory authority
    • F. Locally advanced or metastatic disease in a cancer with at least one palpable subcutaneous malignant lesion(≤ 2 cm in diameter) for treatment with TRK-950 and Imiquimod cream
  • Primary or metastatic tumors measurable per RECIST v1.1 on CT scan or by calipers (subcutaneous lesions)
  • Karnofsky performance of ≥70
  • Life expectancy of at least 3 months
  • Age ≥ 18 years
  • Signed, written IRB-approved informed consent

Exclusion Criteria:

  • Laboratory values or medications that are contraindicated in the selected standard of care treatment regimens
  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Prophylactic antibiotics are acceptable.
  • Pregnant or nursing women
  • Treatment with radiation therapy within 2 weeks, or treatment with surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry.
  • Unwillingness or inability to comply with procedures required in this protocol
  • Known active infection with HIV, hepatitis B, hepatitis C
  • Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  • Patients who are currently receiving any other investigational agent
  • Any contraindicated condition or drug which would make the patient ineligible for the respective treatment regimen that is to be used in combination with TRK-950 (for example, autoimmune disorders for nivolumab or pembrolizumab treatment) as described in the Full Prescribing Information

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): NCT03872947


Contacts
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Contact: Vicki Bauernschub, BSN, RN 602 358 8324 vbauernschub@td2inc.com
Contact: Angela Iheanacho, MS 602 358 8326 aiheanacho@TD2inc.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN,RN,AOCNS    480-323-1339      
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Amanda Woolery, RN       Amanda.woolery@ochsner.org   
United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Angela Alistar, Dr.    973-971-7960    Angela.Alistar@atlantichealth.org   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Medical College of Wisconsin    866-680-0505 ext 8900    cccto@mcw.edu   
Contact: Medical College of Wisconsin    414-805-8900      
France
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Philippe Cassier, M.D.    +33 (0)4 26 55 68 33      
Sponsors and Collaborators
Toray Industries, Inc

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Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT03872947     History of Changes
Other Study ID Numbers: 950P1V02
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Cholangiocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Gemcitabine
Carboplatin
Pembrolizumab
Nivolumab
Irinotecan
Imiquimod
Ramucirumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites