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BRIEF TITLE: 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

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


  • Org Study ID: 950P1V02
  • Secondary ID:
  • NCT ID: NCT03872947
  • NCT Alias:
  • Sponsor: Toray Industries, Inc - Industry
  • Source: 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.

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

Primary Outcomes:

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

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

Primary Outcome 2 - Measure: Blood pressure

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

Primary Outcome 3 - Measure: Heart rate

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

Primary Outcome 4 - Measure: Respiratory rate

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

Primary Outcome 5 - Measure: Temperature

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

Primary Outcome 6 - Measure: Weight

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

Primary Outcome 7 - Measure: Height

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

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

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

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

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

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

Primary Outcome 10 - Time Frame: 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 - Time Frame: 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

Criteria:
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Vicki Bauernschub, BSN, RN

Phone: 602 358 8324

Email: vbauernschub@td2inc.com

Locations

Facility Status Contact
HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Recruiting Joyce Schaffer, MSN,RN,AOCNS
480-323-1339
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Xiomara Menendez, BSN, RN
323-409-4368
Xiomara.Menendez@med.usc.edu
HOAG Memorial Hospital Presbyterian
Newport, California 92663
United States
Recruiting Chi Nguyen, CCRP
949-764-6763
chi.nguyen@hoag.org
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Recruiting Amanda Woolery, RN

Amanda.woolery@ochsner.org
Atlantic Health System
Morristown, New Jersey 07960
United States
Recruiting Angela Alistar, Dr.
973-971-7960
Angela.Alistar@atlantichealth.org
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Recruiting Medical College of Wisconsin
866-680-0505
cccto@mcw.edu
Centre Léon Bérard
Lyon, 69373
France
Recruiting Philippe Cassier, M.D.
+33 (0)4 26 55 68 33