Pharmaceutical sponsor
Taiho Oncology, Inc. Clinical Trials
Studies where Taiho Oncology, Inc. is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 8Lung Cancer, Adjuvant
A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection
The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation…
- Conditions
- Lung Cancer, Adjuvant, Post-surgical, EGFR
- Trial name
- REZILIENT4 (NCT07128199)
- Testing
- TAS6417
- Where
- 253 sites in United States, Argentina and 22 more
- Volunteers
- 360 people
- Sponsor
- Taiho Oncology, Inc.
B-cell Non Hodgkin Lymphoma
A Study of ARC-02 in B-cell NHL
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
- Trial name
- ABLATE-101 (NCT07691606)
- Testing
- ARC-02, Rituximab
- Where
- 29 sites in United States, Australia and 4 more
- Volunteers
- 140 people
- Sponsor
- Taiho Oncology, Inc.
Myelodysplastic Syndromes, Acute Myeloid Leukemia
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms.
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic Syndrome/Neoplasm, Chronic Myelomonocytic Leukemia
- Trial name
- NCT04256317
- Testing
- Azacitidine, ASTX030 (cedazuridine + azacitidine), Cedazuridine
- Where
- 73 sites in United States, Canada and 8 more
- Volunteers
- 316 people
- Sponsor
- Taiho Oncology, Inc.
Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and…
- Trial name
- REZILIENT2 (NCT05967689)
- Testing
- TAS6417, CYP Cocktail, Transporter Cocktail
- Where
- 80 sites in United States, Australia and 10 more
- Volunteers
- 220 people
- Sponsor
- Taiho Oncology, Inc.
Advanced Cholangiocarcinoma, FGFR2 Fusions
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene…
- Conditions
- Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement
- Trial name
- FOENIX-CCA4 (NCT05727176)
- Testing
- TAS-120
- Where
- 65 sites in United States, Argentina and 11 more
- Volunteers
- 120 people
- Sponsor
- Taiho Oncology, Inc.
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
Extension study to provide ongoing long-term treatment with ASTX727 for participants who were benefitting from ASTX727 treatment in a previous Taiho (formerly Astex)-sponsored clinical study of ASTX727 (including, but not limited…
- Conditions
- Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes
- Trial name
- NCT04093570
- Testing
- ASTX727
- Where
- 47 sites in United States, Armenia and 11 more
- Volunteers
- 332 people
- Sponsor
- Taiho Oncology, Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment
This is a Phase 1b, multicenter, open-label, pharmacokinetic (PK), and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams…
- Trial name
- NCT04953910
- Testing
- ASTX727
- Where
- 22 sites in United States, Armenia and 6 more
- Volunteers
- 27 people
- Sponsor
- Taiho Oncology, Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
This is a Phase 1b, multicenter, open-label, PK, and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and…
- Trial name
- NCT04953897
- Testing
- ASTX727
- Where
- 21 sites in United States, Armenia and 6 more
- Volunteers
- 18 people
- Sponsor
- Taiho Oncology, Inc.
Completed, with results posted
All 9Solid Tumor, Adult
Study of ASTX029 in Subjects With Advanced Solid Tumors
This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to participants with advanced…
- Trial name
- NCT03520075
- Testing
- ASTX029
- Where
- 31 sites in United States, France and 2 more
- Volunteers
- 192 people
- Sponsor
- Taiho Oncology, Inc.
Cholangiocarcinoma, Urothelial Cancer
A Study of TAS-120 in Patients With Advanced Solid Tumors
This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120).
- Conditions
- Cholangiocarcinoma, Urothelial Cancer, Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors, Primary CNS Tumors
- Trial name
- NCT02052778
- Testing
- Futibatinib
- Where
- 58 sites in United States, Australia and 11 more
- Volunteers
- 407 people
- Sponsor
- Taiho Oncology, Inc.
Refractory Metastatic Colorectal Cancer
Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients
This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus…
- Trial name
- SUNLIGHT (NCT04737187)
- Testing
- Trifluridine/Tipiracil, Bevacizumab
- Where
- 99 sites in United States, Austria and 12 more
- Volunteers
- 492 people
- Sponsor
- Taiho Oncology, Inc.
Gastric Cancer
A Safety and Efficacy Study in Patients With Gastric Cancer
This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with…
- Trial name
- NCT00400179
- Testing
- S-1/Cisplatin, 5-FU/cisplatin
- Where
- 33 sites in United States, Canada
- Volunteers
- 1,053 people
- Sponsor
- Taiho Oncology, Inc.
Locally Advanced or Metastatic Pancreatic Cancer
Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer
The purpose of this study is to determine whether S-1 is effective in slowing tumor activity in participants with locally advanced or metastatic pancreatic cancer who have not had chemotherapy.
- Trial name
- NCT00651742
- Testing
- S-1
- Volunteers
- 28 people
- Sponsor
- Taiho Oncology, Inc.