A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04479904
• Collaborator: (none)
• Enrollment: 0
• Arm: 1
• Anticipated Duration (Months): 18

Study Details

Study Description

Brief Summary

This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Drug: Famitinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy
• Anticipated Study Start Date: Aug 10, 2020
• Anticipated Primary Completion Date: Dec 10, 2021
• Anticipated Study Completion Date: Feb 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: famitinib	Drug: Famitinib; po

Outcome Measures

Primary Outcome Measures

1. Objective response rate per RECIST 1.1 [up to 24 months]

Secondary Outcome Measures

1. DOR [At pre-defined intervals from initial dose up to 24 months]

   Duration of Response

2. DCR [At pre-defined intervals from initial dose up to 24 months]

   Disease Control Rate

3. PFS [At pre-defined intervals from initial dose up to 24 months]

   Progression-Free-Survival

4. OS [At pre-defined intervals from initial dose up to 24 months]

   Overall survival

5. Adverse events (AE) and serious adverse event (SAE) [At pre-defined intervals from initial dose up to 24 months]

   Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug

6. Plasma concentrations of famitinib and its N-desethyl metabolite [At pre-defined intervals from initial dose up to 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Voluntary participation and written informed consent;

2. Aged 18-75 years (inclusive), males and females;

3. Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy;

4. FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory;

5. At least one measurable lesion that has not been treated locally;

6. ECOG score of 0-1;

7. Expected survival ≥ 12 weeks;

Exclusion Criteria:

1. Presence of multiple factors affecting oral medications;

2. Wounds unhealed over a long period of time, or fractures not completely healed;

3. Known or suspected allergy to investigational drug or any drug related to this trial.

4. Known cases of CNS(Central Nervous System) metastasis;

5. Uncontrolled cardiac diseases or symptoms;

6. Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants;

7. Patients previously treated with FGFR inhibitors (such as erdafitinib)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04479904
• Other Study ID Numbers: SHR-1020-II-204
• First Posted: Jul 21, 2020
• Last Update Posted: Jun 22, 2021
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholangiocarcinoma

Study Results

No Results Posted as of Jun 22, 2021