Health Condition 1: C221- Intrahepatic bile duct carcinoma Health Condition 2: C92- Myeloid leukemia
Conditions
Interventions
Intervention1: Ivosidenib: 250 mg film-coated tablets, 2 tablets OD, Oral, 6 cycles of 28 Days each
Control Intervention1: NA: NA
Sponsors
Servier India Private Limited, Mumbai, India
JSS Medical Research Asia Pacific Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: For CCA Cohort Inclusion Criteria: 1. Participants willing to sign informed consent form (ICF). 2. Adult participants [SM12.1](greater than equal to 18 yrs at time of enrolment) 3. Male or Non-Pregnant, Non-Lactating Female 4. Diagnosis of LA/mCCA, with documented disease progression following at least 1 prior systemic regimen for advanced disease (nonresectable or metastatic). 5. Participants must have documented IDH1 R132 mutated disease (from fresh or banked tumor tissue) based on local laboratory testing. 6. Participants should have adequate hepatic function as defined serum bilirubin, AST, ALT less than equal to 3 ULN & adequate renal function as evidenced by eGFR greater than 30 ml/min 7. Investigator decision to treat with ivosidenib in pre-treated advanced cholangiocarcinoma participants OR as per the label in India For AML Cohort Inclusion Criteria: 1. Participants willing to sign informed consent form (ICF) 2. Adult participants (18 yrs at the time of enrollment) 3. Male or Non-Pregnant, Non-Lactating Female 4. Newly Diagnosed AML 5. Documented IDH1 mutated disease 6. Participants should have adequate hepatic function as defined serum bilirubin, AST,ALT 3 ULN & adequate renal function as evidenced by eGFR 30 ml/min 7. Investigator decision to treat with ivosidenib in chemotherapy ineligible AML OR participants as per the label in India
Exclusion criteria
Exclusion criteria: For CCA Cohort- 1. Any contraindications to ivosidenib treatment as per the latest approved India PI. For AML Cohort- Any contraindications to ivosidenib treatment as per the latest approved India PI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CCA: To evaluate the safety of ivosidenib as monotherapy in patients with previously treated LA/mCCA with an IDH1 R132 mutation AML: To evaluate the safety of ivosidenib in combination with azacitidine in patients with newly diagnosed AML with an IDH1 R132 mutation who are not eligible to receive standard induction chemotherapyTimepoint: CCA:-Baseline to End of the study AML:-Baseline to End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| CCA: To evaluate the effectiveness of ivosidenib as monotherapy in patients with previously treated LA/mCCA with an IDH1 R132 mutation[P AML: To evaluate the effectiveness of ivosidenib in combination with azacitidine in patients with newly diagnosed[PS18.1] AML with an IDH1 R132 mutation who areTimepoint: AML & CCA: -Tumor assessments will be performed at screening, C3D15 (Week 11) & at EOS (Week 25) for CCA Disease response to treatment will be assessed through the evaluation of bone marrow biopsies and/or aspirates, along with complete blood counts & examination of peripheral blood films at Day 1 ( 7 days) of Weeks 5, 13 & at EOS. | — |
Countries
India
Contacts
Public ContactShalini Verma
Servier India Private Limited
Outcome results
None listed