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

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

INTRODUCTION

  • Org Study ID: 950P1V02
  • Secondary ID: N/A
  • NTC ID: NCT03872947
  • Sponsor: 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, Bevacizumab, as well as Nivolumab / Ipilimumab 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 7) Bevacizumab or 8) Nivolumab / Ipilimumab 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.

  • Overall Status
    Recruiting
  • Start Date
    April 26, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Frequency of patients experiencing treatment emergent adverse events as assessed by CTCAE v5.0

Primary Outcome 1 - Timeframe: through study completion, an average of 1 year

Primary Outcome 2 - Measure: Blood pressure

Primary Outcome 2 - Timeframe: through study completion, an average of 1 year

Primary Outcome 3 - Measure: Heart rate

Primary Outcome 3 - Timeframe: through study completion, an average of 1 year

Primary Outcome 4 - Measure: Respiratory rate

Primary Outcome 4 - Timeframe: through study completion, an average of 1 year

Primary Outcome 5 - Measure: Temperature

Primary Outcome 5 - Timeframe: through study completion, an average of 1 year

Primary Outcome 6 - Measure: Weight

Primary Outcome 6 - Timeframe: through study completion, an average of 1 year

Primary Outcome 7 - Measure: Height

Primary Outcome 7 - Timeframe: through study completion, an average of 1 year

Primary Outcome 8 - Measure: Performance status using Karnofsky performance status criteria

Primary Outcome 8 - Timeframe: through study completion, an average of 1 year

Primary Outcome 9 - Measure: QTc interval determined from 12-lead Electrocardiogram

Primary Outcome 9 - Timeframe: through study completion, an average of 1 year

Primary Outcome 10 - Measure: QRS interval determined from 12-lead Electrocardiogram

Primary Outcome 10 - Timeframe: through study completion, an average of 1 year

Primary Outcome 11 - Measure: Frequency of patients with laboratory abnormalities (Complete Blood Count, Coagulation, Urinalysis and Serum Chemistry)

Primary Outcome 11 - Timeframe: through study completion, an average of 1 year

CONDITION

  • Solid Tumor
  • Colon Cancer
  • Cholangiocarcinoma
  • Bladder Cancer
  • Ovarian Cancer
  • Gastric Cancer
  • Palpable Subcutaneous Malignant Lesions
  • Renal Cell Carcinoma
  • Melanoma

ELIGIBILITY

Inclusion Criteria:
Histologically confirmed solid malignancy for which the following treatment regimens are warranted:
A. Colorectal Cancer with no prior history of treatment with Irinotecan alone or in combination: FOLFIRI as standard of care

- B. Cholangiocarcinoma, Bladder Cancer with no prior history of treatment with Gemcitabine alone or in combination: 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 and have no prior history of treatment with gemcitabine alone or in combination: Gemcitabine / Carboplatin as standard of care

- D. Gastric Cancer including Gastroesophageal Junction with no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug: 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 (US Sites Only)

- G. Renal Cell Carcinoma with no prior history of treatment with Bevacizumab alone or in combination: Bevacizumab as standard of care

- H. Melanoma patients who progressed while taking Nivolumab, Pembrolizumab, or Ipilimumab, within the last 6 months prior to cycle 1 day 1

- I. Melanoma patients who have not been treated with Nivolumab, Pembrolizumab, or Ipilimumab: Nivolumab / Ipilimumab as standard of care

- J. Colorectal Cancer patients who progressed on FOLFIRI or any other Irinotecan-containing therapy regimen within the last 6 months prior to cycle 1 day 1

- 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 602 358 8324

Email: vbauernschub@td2inc.com

LOCATION

Facility Status Contact
Facility: HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact: Contact
Joyce Schaffer, MSN,RN,AOCNS
480-323-1339 8900
Xiomara.Menendez@med.usc.edu
Facility: USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Xiomara Menendez, BSN, RN
323-409-4368
chi.nguyen@hoag.org
Facility: HOAG Memorial Hospital Presbyterian
Newport, California 92663
United States
Status: Recruiting Contact: Contact
Chi Nguyen, CCRP
949-764-6763
Amanda.woolery@ochsner.org
Facility: Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Status: Recruiting Contact: Contact
Amanda Woolery, RN
973-971-7960
Angela.Alistar@atlantichealth.org
Facility: Atlantic Health System
Morristown, New Jersey 07960
United States
Status: Recruiting Contact: Contact
Angela Alistar, Dr.
866-680-0505
cccto@mcw.edu
Facility: Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
Medical College of Wisconsin
414-805-8900
Facility: Centre Léon Bérard
Lyon, 69373
France
Status: Recruiting Contact: Contact
Medical College of Wisconsin
+33 (0)4 26 55 68 33