single arm prospective phase II clinical trial to evaluate use of Trastuzumab emtansine as second-line therapy in HER2 positive Advanced Biliary tract cancers -(TAB-3 trial)

Phase 2

• Conditions: Health Condition 1: C249- Malignant neoplasm of biliary tract, unspecified

• Registration Number: CTRI/2023/07/055785
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Histologically confirmed adenocarcinoma of the biliary tract (including gallbladder cancer, intrahepatic cholangiocarcinoma, and perihilar cholangiocarcinoma), with the following specifications

1.Subjects must provide written informed consent prior to the performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up assessments and procedures.

2.Patients who have progressed on gemcitabine-based first-line therapy, or relapsed within 6 months of stopping gemcitabine or capecitabine or S1 based regime if used as adjuvant therapy.

3.HER2 positive by IHC as per criteria used for gastric cancers.

4.Age 18 to 75 years with ECOG PS 0-2.

5.The patient does not have any contraindications to receiving trastuzumab emtansine.

6.Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction (EF) greater than or equal to 50% or above the lower limit of normal. ECG with no clinically relevant abnormalities.

7.Women of childbearing age should have a negative pregnancy test at the time of enrolment and should be willing to use adequate contraception during the treatment phase of the trial.

8.Unresectable or metastatic cancer.

9.Adequate hematological, hepatic, and renal function parameters-

Hematological Hb more than 80 g per L, ANC more than or equal to 1.5 x 109per L, platelets more than or equal to 100 x 109 per L.

Liver functions- bilirubin less than or equal to 2 x upper limit normal (ULN), AST and ALT less than or equal to 5 x ULN, alkaline phosphatase less than or equal to 6 x upper limit normal (ULN) S. albumin more than or equal to 30 g per L.

Renal function- Creatinine less than or equal to 1.5 ULN, Creatinine clearance greater than or equal to 30 mL per min.

10.A life expectancy of at least 12 weeks.

Exclusion Criteria

1.Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III to IV, Clinically significant valvular defect.

2.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.

3.Severe dyspnea at rest due to complications of advanced malignancy or requiring supplemental oxygen therapy.

4.On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study.

5.Known hypersensitivity or contraindications against trastuzumab emtansine.

6.Clinically significant valvular defect.

7.Baseline neuropathy > NCI Grade I.

8.Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified