Ovarian Cancer Clinical Trial

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

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, Gemcitabine / Carboplatin / Bevacizumab, Topotecan, and Pegylated liposomal doxorubicin (PLD) for selected advanced solid tumors.

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Full 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 8) Gemcitabine / Carboplatin / Bevacizumab, 9)PLD, 10) Carboplatin / PLD / Bevacizumab or 11) Paclitaxel 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed solid malignancy for which the following treatment regimens are warranted:
Arm A. Colorectal Cancer with no prior history of treatment with Irinotecan alone or in combination: FOLFIRI as standard of care
Arm B. Cholangiocarcinoma, Bladder Cancer with no prior history of treatment with Gemcitabine alone or in combination: Gemcitabine / Cisplatin as standard of care
Arm 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
Arm 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
Arm 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
Arm 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)
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 H. Melanoma patients who progressed while taking Nivolumab, Pembrolizumab, or Ipilimumab, within the last 6 months prior to cycle 1 day 1
Arm 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
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

Arm O. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, as defined below and who are eligible for topotecan or pegylated liposomal doxorubicin as standard of care for dosing of TRK-950

Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response, and then progressed between 3 months and less than or equal to 6 months after the last date of platinum.
Patients who have received 2 to 5 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum.
Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy
Arm Q. Gastric Cancer including GEJ cancer with only 1 prior treatment regimen, which recurred during or within 4 months after frontline treatment, and no prior history of treatment with Ramucirumab, Paclitaxel or any Taxane class drug for metastatic disease: eligible to receive Ramucirumab/Paclitaxel as standard of care
Arm R. Clear cell 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 S. Platinum Sensitive epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 2 prior treatment lines who have recurred > 182 days after most recent platinum-based chemotherapy and who are eligible for carboplatin, PLD, and bevacizumab as standard of care

The histological subtypes of the carcinoma that qualify for enrollment include serous adenocarcinoma, endometrioid adenocarcinoma, carcinosarcoma of the ovary, or adenocarcinoma not otherwise specified (NOS)
Patients with or without the breast cancer susceptibility 1/2 (BRCA1/2) mutations are eligible, provided that patients with the BRCA1/2 mutations have previously received PARP inhibitor treatment

Arm T. Platinum Resistant epithelial ovarian, primary peritoneal or fallopian tube cancer with ≤ 5 prior treatment regimens, or as defined below, and who are eligible for paclitaxel as standard of care

Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (complete response/remission (CR) or partial response/remission (PR), and then progressed between 90 days to less than 183 days after the last date of platinum.
Patients who have received multiple lines of platinum therapy must have progressed on the latest platinum, or within 183 days after the date of the last dose of the latest platinum
Patients with or without the BRCA1/2 mutations are eligible, provided that patients with the BRCA1/2 mutations have previously received PARP inhibitor treatment
Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy
The histological subtypes of the carcinoma that qualify for enrollment include serous adenocarcinoma, endometrioid adenocarcinoma, carcinosarcoma of the ovary, or adenocarcinoma not otherwise specified (NOS)
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, targeted therapy or investigational therapy within four weeks prior to initiation of study treatment (6 weeks for nitrosoureas or mitomycin C, and 2 weeks or 5 half-lives whichever is longer for TKIs).
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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

187

Study ID:

NCT03872947

Recruitment Status:

Recruiting

Sponsor:

Toray Industries, Inc

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There are 14 Locations for this study

See Locations Near You

HonorHealth Research Institute
Scottsdale Arizona, 85258, United States
AOA-HOPE
Tucson Arizona, 85711, United States More Info
AOA-HOPE
Contact
520-886-0206
Julie Klinker, BSN
Contact
(520)269-3821
[email protected]
USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Xiomara Menendez, BSN, RN
Contact
323-409-4368
[email protected]
HOAG Memorial Hospital Presbyterian
Newport California, 92663, United States More Info
Chi Nguyen, CCRP
Contact
949-764-6763
[email protected]
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Atlantic Health System
Morristown New Jersey, 07960, United States More Info
Angela Alistar, Dr.
Contact
973-971-7960
[email protected]
Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States More Info
Priyanka Patel, BS
Contact
[email protected]
Brianne Boljonis, BSN,RN
Contact
[email protected]
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center)
Eugene Oregon, 97401, United States More Info
Oncology Associates of Oregon, P.C.
Contact
541-683-5001
Jeanne Schaffer, RN-BSN
Contact
[email protected]
Northwest Cancer Specialists
Portland Oregon, 97227, United States More Info
Northwest Cancer Specialists
Contact
503-528-5005
Amber Holden, BA
Contact
(360)597-1300
[email protected]
Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Texas Oncology - Downtown Fort Worth Cancer Center
Fort Worth Texas, 76104, United States More Info
Nori Sullivan, RN, BSN, CCRC
Contact
817-413-1760
[email protected]
Virginia Cancer Specialists, PC
Leesburg Virginia, 20176, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Centre Léon Bérard
Lyon , 69373, France More Info
Philippe Cassier, M.D.
Contact
+33 (0)4 26 55 68 33

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

187

Study ID:

NCT03872947

Recruitment Status:

Recruiting

Sponsor:


Toray Industries, Inc

How clear is this clinincal trial information?

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