Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer

Learn more about:
Related Clinical Trial
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer Metabolic Stress-induced Exercise to Prevent Loss of Muscle Mass in Patients With Pancreatic and Biliary Tract Cancer The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer A Study of ABL001 in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy Predicting Disease Progression and/or Recurrence in Cancer Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab Endoluminal Radiofrequency Ablation for the Treatment of Malignant Biliary Stenosis A Phase 1/2 Study of SC-43 in Combination With Cisplatin The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Unresectable Biliary Tract Cancer. A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer A Trial of SHR1258 in Patients With Biliary Tract Cancer Perception Prognosis, Goals of Treatment, and Communication IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Tremelimumab With Chemoembolization or Ablation for Liver Cancer Preoperative Nutritional Support in Malnutritional Cancer Patients Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures. Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions Early Palliative Care on Quality of Life of Advanced Cancer Patients Patient Activation Through Counseling, Exercise and Mobilization Extracellular RNA Markers of Liver Disease and Cancer X-MAS Biliary Study With Covered Biliary Stent A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 Anti-HER2 Therapy in Patients of HER2 Positive Metastatic Carcinoma of Digestive System The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy Phase II Study of Refametinib, a MEK Inhibitor, as Second-line Treatment in Advanced Biliary Tract Adenocarcinoma Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma Combination of Targeted and Immunotherapy for Advanced Biliary Tract and Esophagogastric Gastric Cancer A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers A Prospective Cohort Study of Patients With Hepatobiliary Cancer Treated With Immune Checkpoint Inhibitors GTX Regimen for Biliary Cancers Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic BTC Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer FOLFIRINOX for 2nd-line Treatment of BTC Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study Pemetrexed in Combination With Erlotinib as a Salvage Treatment in Patients With Metastatic Biliary Tract Cancer (BTC) Who Failed Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy Study of Pembrolizumab in Metastatic Biliary Tract Cancer as Second-line Treatment After Failing to at Least One Cytotoxic Chemotherapy Regimen: Integration of Genomic Analysis to Identify Predictive Molecular Subtypes A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma) Trastuzumab in HER2-positive Biliary Tract Cancer Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer Who Failed Gemcitabine-based Combination Chemotherapy Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase Second Line Therapy in Advanced Biliary Tract Cancer Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer Study of TH-302 Monotherapy as Second-line Treatment in Advanced Biliary Tract Cancer Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer Varlitinib Plus Capecitabine in Chinese Patients With Advanced or Metastatic Biliary Tract Cancer Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer A Study of RC48 in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer. Case Series Study of Biliary Tract Cancer Patients in Japan GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer Molecular Profiling of Advanced Biliary Tract Cancers MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer Allogeneic NK Cell (“SMT-NK”) in Combination With Pembrolizumab in Advanced Biliary Tract Cancer Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer Vessel Resection and Reconstruction of Biliary Tract Cancers Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancers A Phase I Study of Adjuvant Chemotherapy With GS in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer (BTC) With Node Metastasis A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC) NGS as the First-line Treatment in Advanced Biliary Tract Cancer Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer Molecular Profiling of Advanced Biliary Tract Cancers

Brief Title

Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer

Official Title

Open-Label, Multicenter, Phase II/III Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer After Gemcitabine and Cisplatin-Based Treatment Failure

Brief Summary

      The primary objective are:

      To assess the safety and tolerability of the combination of D07001-softgel capsules and
      Xeloda/TS-1.

      To evaluate the efficacy of the combination of D07001-softgel capsules and Xeloda/TS-1, as
      assessed by disease control rate (DCR).
    

Detailed Description

      This open label, multicenter study will be conducted in 2 stages: a dose-finding stage (Phase
      IIa) and a dose-expansion stage (Phase IIb/III).

      In phase IIa, eligible patients will be assigned to receive oral D07001-softgel on Days 1, 3,
      5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle (9 doses per cycle) and Xeloda (or TS-1) twice
      daily on Day 1-14 of a 21-day cycle.

      A modified 3+3 dose-finding design method will be applied to identify dose-limiting
      toxicities (DLTs) and establish the selected dose of D07001-softgel capsules plus Xeloda (or
      TS-1).

      In phase IIb/III,the first 40 subjects (20 subjects per arm) will be randomly allocated in a
      1:1 ratio in two arms. Arm A will receive active symptom control (ASC) with the selected dose
      from dose-finding stage of D07001-softgel capsules and Xeloda (or TS-1), in 21-day cycles. In
      arm B, subjects will receive ASC with mFOLFOX treatment. After the last subject of first 40
      subjects will be completed the visit in the end of treatment, an adaptive interim analysis
      will be planned to re-estimate the required sample size based on the result of DCR if needed.
      The sponsor team will determine whether the study will be continued or stopped for futility.

      If the study continues to proceed, the total subject number will be based on the decision
      from the results of interim study. The rest of subjects will be randomized to receive the
      combination of study drug or active-control drug with the same allocation in two arms. Both
      groups will continue the therapy until disease progression, withdrawn consent, or when
      another treatment discontinuation criterion is met.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Incidence of adverse events (AEs)/ serious adverse event (SAEs)

Secondary Outcome

 Phase IIa and IIb: Pharmacokinetics (PK)- maximum plasma concentration (Cmax) of gemcitabine (dFdC), difluorodeoxyuridine (dFdU), capecitabine, 5-FU, Tegafur, Gimeracil, and Oteracil potassium

Condition

Biliary Tract Cancer

Intervention

D07001-softgel capsules + Xeloda (or TS-1)

Study Arms / Comparison Groups

 Phase IIa:Dose-Finding Stage
Description:  Level -4: 20 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg/m^2 TS-1).
Level -3: 40 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg/m^2 TS-1).
Level -2: 60 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg/m^2 TS-1).
Level -1: 80 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg/m^2 TS-1).
Level 1 (starting dose): 100 mg D07001-softgel capsules plus 625 mg/m^2 Xeloda (or 20/30/40 mg/m^2 TS-1).
Level 2: 100 mg D07001-softgel capsules plus 800 mg/m^2 Xeloda (or 30/40/50 mg/m^2 TS-1).
Level 3: 100 mg D07001-softgel capsules plus 1000 mg/m^2 Xeloda (or 40/50/60 mg/m^2 TS-1).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

180

Start Date

November 2021

Completion Date

December 2026

Primary Completion Date

July 2026

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female patients aged 18 years or older at screening (aged 20 years or older in
             Taiwan)

          2. Histopathological or cytologic diagnosis of unresectable metastatic or locally
             advanced BTC (cholangiocarcinoma or gallbladder cancer)

          3. Subject must have failed from first line gemcitabine and cisplatin-based therapy with
             clear evidence of disease progression

          4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1

          5. Life expectancy is >12 weeks

          6. Adequate bone marrow function, demonstrated by:

               1. Absolute neutrophil count (ANC) ≥1,500 cell/mm3

               2. Platelet count ≥ 100,000 cells/mm3

               3. Hemoglobin ≥ 9 g/dL

          7. Adequate liver function, demonstrated by:

               1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of
                  normal (ULN), or ≤5.0 x ULN in the case of liver metastases

               2. Total bilirubin ≤1.5 x ULN

               3. Albumin ≥3.0 g/dL

               4. International normalized ratio (INR) <1.5

          8. Adequate renal function, demonstrated by:

               1. Serum creatinine ≤1.5 x ULN

               2. Creatinine clearance ≥ 60mL/min calculated by Cockcroft-Gault formula or directly
                  measured with 24hr urine collection

          9. A negative serum pregnancy test at screening and is not breastfeeding in woman of
             childbearing potential

         10. Women of childbearing potential or male subjects must use a medically acceptable form
             of contraception as 2 barrier methods (e.g., combination of condom, diaphragm, or
             intrauterine device), hormonal contraception (estrogen or progesterone agents) or 1
             barrier method in combination with spermicide. Birth control is required 1 month prior
             to screening, for the duration of their study participation, and for 1 month after the
             end of the study; female partners of male subjects must adhere to the same birth
             control methods.

         11. Provision of a signed and dated written Informed Consent Form (ICF) prior to any study
             specific procedures

         12. Subject is willing to comply with protocol-required visit schedule and visit
             requirements

         13. No more than 60 days have elapsed between completion of the prior line of chemotherapy
             or CCRT and enrollment

         14. Subject has not received intervening systemic therapy since first-line treatment

        Exclusion Criteria:

          1. More than one prior chemotherapy regimen or any systemic therapy (chemotherapy,
             biologics, immunotherapy, or investigational agents) other than first line gemcitabine
             and cisplatin-based therapy for unresectable metastatic or locally advanced BTC Note:
             prior radiation (with or without radiosensitizing doses of chemotherapy) or
             fluoropyrimidine chemotherapy are allowed as postsurgical adjuvant therapy.

          2. Diagnosis of active malignancy other than BTC within the past 2 years, except
             nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with
             curative intent

          3. Prior discontinuation of gemcitabine because of pulmonary or hepatic toxicity or
             hemolytic uremic syndrome (HUS) or hypersensitivity, allergic reaction, or intolerance

          4. Known or suspected hypersensitivity to capecitabine, tegafur, gimeracil, oteracil
             potassium, oxaliplatin or other platinum compounds, leucovorin products, folic acid or
             folinic acid, 5-fluorouracil or their excipients.

          5. Prior discontinuation of fluoropyrimidine because of any unexpected or severe
             reaction.

          6. Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days
             prior to the date of enrollment.

          7. Under flucytosine treatment.

          8. Residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2
             neuropathy and alopecia are permitted)

          9. Any GI disorder which would significantly impede absorption of an oral agent

         10. Known brain or leptomeningeal metastases

         11. Surgery or radiation therapy within the past 28 days

         12. Any active disease or condition that would not permit compliance with the protocol

         13. Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
             unstable angina, congestive heart failure, or New York Heart Association [NYHA] Grade
             2 or greater), or uncontrolled serious cardiac arrhythmia

         14. Have documented cerebrovascular disease

         15. Have a seizure disorder not controlled on medication (based on decision of
             Investigator)

         16. Received an investigational agent within 28 days of enrollment

         17. Have an uncontrolled active viral, bacterial, or systemic fungal infection

         18. Known human immunodeficiency virus (HIV) infection

         19. Have hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in medical
             history. If positive results are not indicative of true active or chronic infection,
             the subject can enter the study after discussion and agreement between the
             Investigator and the Clinical Research Organization (CRO) Medical Monitor

         20. Received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks
             prior to screening

         21. History of drug or alcohol abuse within last year

         22. Have any other serious medical condition that, in the Investigator's medical opinion,
             would preclude safe participation in, and compliance with, a clinical trial
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Li-Tzong Chen, Ph.D, 886-87977607, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT05065957

Organization ID

Inno-Go-05


Responsible Party

Sponsor

Study Sponsor

InnoPharmax Inc.


Study Sponsor

Li-Tzong Chen, Ph.D, Principal Investigator, National Institute of Cancer Research


Verification Date

September 2021