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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 30, 2019
Sponsor:
Information provided by (Responsible Party):
Toray Industries, Inc

Tracking Information
First Submitted Date  ICMJE March 7, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE April 26, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: through study completion, an average of 1 year ]
  • Blood pressure [ Time Frame: through study completion, an average of 1 year ]
    mmHg
  • Heart rate [ Time Frame: through study completion, an average of 1 year ]
    bpm
  • Respiratory rate [ Time Frame: through study completion, an average of 1 year ]
    bpm
  • Temperature [ Time Frame: through study completion, an average of 1 year ]
    °F or °C
  • Weight [ Time Frame: through study completion, an average of 1 year ]
    lbs/kg
  • Height [ Time Frame: through study completion, an average of 1 year ]
    inches/cm
  • Performance status using Karnofsky performance status criteria [ Time Frame: through study completion, an average of 1 year ]
  • QTc interval determined from 12-lead Electrocardiogram [ Time Frame: through study completion, an average of 1 year ]
    msec
  • QRS interval determined from 12-lead Electrocardiogram [ Time Frame: through study completion, an average of 1 year ]
    msec
  • Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry) [ Time Frame: through study completion, an average of 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: through study completion, an average of 1 year ]
  • Blood pressure [ Time Frame: through study completion, an average of 1 year ]
    mmHg
  • Heart rate [ Time Frame: through study completion, an average of 1 year ]
    bpm
  • Respiratory rate [ Time Frame: through study completion, an average of 1 year ]
    bpm
  • Temperature [ Time Frame: through study completion, an average of 1 year ]
    °F or °C
  • Weight [ Time Frame: through study completion, an average of 1 year ]
    lbs/kg
  • Height [ Time Frame: through study completion, an average of 1 year ]
    inches/cm
  • Performance status using Karnofsky performance status criteria [ Time Frame: through study completion, an average of 1 year ]
  • QTc and QRS intervals determined from Electrocardiogram [ Time Frame: through study completion, an average of 1 year ]
    msec
  • Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry) [ Time Frame: through study completion, an average of 1 year ]
Change History Complete list of historical versions of study NCT03872947 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Overall response rate (ORR) [ Time Frame: through study completion, an average of 1 year ]
  • Disease Control Rate (DCR) [ Time Frame: through study completion, an average of 1 year ]
  • Plasma concentration of TRK-950 [ Time Frame: through study completion, an average of 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Colon Cancer
  • Cholangiocarcinoma
  • Bladder Cancer
  • Ovarian Cancer
  • Gastric Cancer
  • Palpable Subcutaneous Malignant Lesions
Intervention  ICMJE
  • 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
  • Drug: Gemcitabine
    Intravenously over 30 minutes
  • Drug: Cisplatin
    Intravenously over 60 minutes
  • Drug: Carboplatin
    Intravenously
  • Biological: Ramucirumab
    Intravenously over 60 minutes
  • Drug: Paclitaxel
    Intravenously
  • Biological: Nivolumab
    Intravenously over 30 minutes
  • Biological: Pembrolizumab
    Intravenously over 30 minutes
  • Drug: Imiquimod Cream
    Topically
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: TRK-950
    • Drug: Irinotecan
    • Drug: Leucovorin
    • Drug: 5-FU
  • 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.
    Interventions:
    • Biological: TRK-950
    • Drug: Gemcitabine
    • Drug: Cisplatin
  • 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.
    Interventions:
    • Biological: TRK-950
    • Drug: Gemcitabine
    • Drug: Carboplatin
  • 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.
    Interventions:
    • Biological: TRK-950
    • Biological: Ramucirumab
    • Drug: Paclitaxel
  • 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.

    Interventions:
    • Biological: TRK-950
    • Biological: Nivolumab
    • Biological: Pembrolizumab
  • 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).
    Interventions:
    • Biological: TRK-950
    • Drug: Imiquimod Cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vicki Bauernschub, BSN, RN 602 358 8324 vbauernschub@td2inc.com
Contact: Angela Iheanacho, MS 602 358 8326 aiheanacho@TD2inc.com
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03872947
Other Study ID Numbers  ICMJE 950P1V02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Toray Industries, Inc
Study Sponsor  ICMJE Toray Industries, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Toray Industries, Inc
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP