A Study of TAS-120 in Patients With Advanced Solid Tumors
Status: | Recruiting |
---|---|
Conditions: | Prostate Cancer, Liver Cancer, Cancer, Brain Cancer, Blood Cancer, Women's Studies, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/21/2018 |
Start Date: | July 2014 |
End Date: | September 2019 |
Contact: | Jerry Huang, MD |
Email: | jhuang@taihooncology.com |
Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations
This is an open-label, nonrandomized, Phase 1 dose-escalation, dose-expansion, and Phase 2
study targeting tumors with FGF/FGFR aberrations. The purpose of the study is to evaluate the
safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of TAS-120 in patients
with advanced solid tumors with and without FGF/FGFR-related abnormalities.
The study will be conducted in 3 parts, (1) Dose escalation to determine the MTD and/ or RP2D
of TAS-120 in which this part of the study has been completed; (2) Phase 1 expansion to
further evaluate the safety and efficacy of RP2D of TAS-120 in patients with tumors harboring
specific FGFR aberrations, specifically in patients with cholangiocarcinoma, gliomas ,
urothelial carcinomas and any other tumors with FGFR fusion or activating mutation or
amplification. Up to approximately 185 patients will be enrolled in the phase 1 expansion;
and (3) Phase 2 study to confirm ORR of TAS-120 in intra-hepatic CCA patients with tumors
harboring FGFR2 gene fusions. Approx. 100 patients will be enrolled in phase 2.
study targeting tumors with FGF/FGFR aberrations. The purpose of the study is to evaluate the
safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of TAS-120 in patients
with advanced solid tumors with and without FGF/FGFR-related abnormalities.
The study will be conducted in 3 parts, (1) Dose escalation to determine the MTD and/ or RP2D
of TAS-120 in which this part of the study has been completed; (2) Phase 1 expansion to
further evaluate the safety and efficacy of RP2D of TAS-120 in patients with tumors harboring
specific FGFR aberrations, specifically in patients with cholangiocarcinoma, gliomas ,
urothelial carcinomas and any other tumors with FGFR fusion or activating mutation or
amplification. Up to approximately 185 patients will be enrolled in the phase 1 expansion;
and (3) Phase 2 study to confirm ORR of TAS-120 in intra-hepatic CCA patients with tumors
harboring FGFR2 gene fusions. Approx. 100 patients will be enrolled in phase 2.
Phase 1 Dose Escalation Phase 1 Dose Escalation has been completed as of Dec 2017
Phase 1 Dose Expansion:
Up to approximately 185 patients will be enrolled among the 8 groups as outlined below:
- Group 1- CCA (iCCA or eCCA) with FGFR2 gene fusions.
- Group 2- CCA (iCCA or eCCA) with FGFR2 gene fusions that are chemotherapy naive or
intolerant to first line chemotherapy (i.e., on chemotherapy regimen ≤ 1 cycle).
- Group 3 - CCA (iCCA or eCCA) with FGFR2 gene fusions treated with prior FGFR inhibitors.
- Group 4 - CCA (iCCA or eCCA) with other FGFR2 abnormalities, ie, gene mutations,
rearrangements or amplifications.
- Group 5 - GBM or grade III glioma (i.e, anaplastic astrocytoma or anaplastic
oliogodendroglioma) with FGFR gene fusions or activating mutations
- Group 6 - Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating
mutations.
- Group 7: Basket of tumor types with tumors harboring FGFR2 amplification (≥10 copies).
- Group 8 - Basket of tumor types (except CCA, brain tumors and advanced urothelial
carcinomas) with tumors harboring FGFR gene fusions or activating mutations.
Phase 2:
Approximately 100 iCCA patients with confirmed FGFR2 gene fusions will be treated. Patients
will be centrally screened for FGFR2 gene fusions. This is a Single arm study with the
primary endpoint of ORR.
Phase 1 Dose Expansion:
Up to approximately 185 patients will be enrolled among the 8 groups as outlined below:
- Group 1- CCA (iCCA or eCCA) with FGFR2 gene fusions.
- Group 2- CCA (iCCA or eCCA) with FGFR2 gene fusions that are chemotherapy naive or
intolerant to first line chemotherapy (i.e., on chemotherapy regimen ≤ 1 cycle).
- Group 3 - CCA (iCCA or eCCA) with FGFR2 gene fusions treated with prior FGFR inhibitors.
- Group 4 - CCA (iCCA or eCCA) with other FGFR2 abnormalities, ie, gene mutations,
rearrangements or amplifications.
- Group 5 - GBM or grade III glioma (i.e, anaplastic astrocytoma or anaplastic
oliogodendroglioma) with FGFR gene fusions or activating mutations
- Group 6 - Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating
mutations.
- Group 7: Basket of tumor types with tumors harboring FGFR2 amplification (≥10 copies).
- Group 8 - Basket of tumor types (except CCA, brain tumors and advanced urothelial
carcinomas) with tumors harboring FGFR gene fusions or activating mutations.
Phase 2:
Approximately 100 iCCA patients with confirmed FGFR2 gene fusions will be treated. Patients
will be centrally screened for FGFR2 gene fusions. This is a Single arm study with the
primary endpoint of ORR.
Inclusion Criteria:
Has histologically or cytologically confirmed, locally advanced, metastatic cancer meeting
the following criteria:
Phase 1 Expansion
1. Patient has failed all standard therapies or standard therapy does not exist or is not
tolerated.
2. Patient has specific FGF/FGFR aberrations
- Intrahepatic or extrahepatic cholangiocarcinoma with FGFR2 gene fusions or other
FGFR2 abnormalities, i.e., gene mutations (see Appendix A), rearrangements or
amplifications
- Glioblastoma or grade III glioma (i.e., anaplastic astrocytoma or anaplastic
oligodendroglioma) with FGFR gene fusions or activating mutations.
- Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
- All other tumor types harboring FGF9, FGF19 or FGFR2 amplifications (≥ 10
copies), FGFR gene fusions, or FGFR activating mutations
Phase 2
1. Patient has histologically or cytologically confirmed, locally advanced, metastatic,
unresectable iCCA harboring FGFR2 gene fusions based on results from a NGS assay by
the Sponsor's designated central laboratory
2. Patient has been treated with and failed at least one prior systemic gemcitabine and
platinum-based chemotherapy for the advanced disease
3. Must have documentation of radiographic progression of disease on prior systemic
therapy
4. Patient has measurable disease as defined by Response Evaluation Criteria in Solid
Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or RANO
criteria (2010) for brain tumors.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. Adequate organ function
Exclusion Criteria:
A patient will be excluded from this study if any of the following criteria are met:
1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus
homeostasis.
2. History and/or current evidence of clinically significant ectopic
mineralization/calcification.
3. History and/or current evidence of clinically significant retinal disorder confirmed
by retinal examination.
4. A serious illness or medical condition(s)
We found this trial at
28
sites
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Lecia Sequist, MD, MPH
Phone: 617-643-0815
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Phone: 609-250-7208
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Boston, Massachusetts 02215
Phone: 617-667-2100
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Phone: 626-471-9200
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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900 West Faris Road
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Principal Investigator: Ki Chung, MD
Phone: 864-455-3600
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Houston, Texas 77030
Principal Investigator: Funda Meric-Bernstam, MD
Phone: 713-792-3737
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
Milwaukee, Wisconsin
(414) 955-8296
Phone: 866-680-0505
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Florida Hospital Florida Hospital is one of the country
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 609-250-7208
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, Pennsylvania 19124
Phone: 215-537-6438
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Philadelphia, Pennsylvania 19107
Phone: 215-955-6407
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Phone: 412-623-5396
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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