Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer

NCT02501603 | Completed Phase 2

• 1 other identifier: 4-2015-0244
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for target enriched patients in gastric cancer.

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (1)

• compare progression free survival as measured by RECIST 1.1

  To identify antitumor activity of afatinib plus weekly taxol(paclitaxel) and explore predictive biomarker

  Every 6 weeks until progression, an expected average of 10 months

Secondary Outcomes (2)

• antitumor efficacy as measured by RECIST 1.1

  every 6 weeks until progression, an expected average of 10 months

• safety as measured by CTCAE

  every 3 weeks until progression, an expected average of 10 months

Study Arms (1)

afatinib plus paclitaxel

EXPERIMENTAL

afatinib plus paclitaxel

Drug: afatinib; Drug: paclitaxel

Interventions

afatinib DRUG

Afatinib 40mg daily oral administration

afatinib plus paclitaxel

paclitaxel DRUG

Paclitaxel 80mg/m2 IV weekly (day 1,8,15)

afatinib plus paclitaxel

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
• EGFR 2+ or 3+ expression (immunohistochemistry)
• ECOG performance status of 0 to 1
• Male or female; ≥ 19 years of age
• Documented disease progression after one prior therapy, in locally advanced or metastatic setting
• patients received last adjuvant chemotherapy less than six months can be enrolled into this study
• Her2 positive patients must be progressed after prior trastuzumab based chemotherapy
• Subjects with measurable lesion (using RECIST 1.1 criteria)
• Subjects who meet the following criteria:
• Absolute neutrophil count (ANC) ≥ 1000 /µL (\*ANC = Neutrophil segs ＋ Neutrophil bands)
• Platelet count ≥ 80,000/ µL
• Serum creatinine \< 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥50 mL/min using Cockcroft, Gault method
• AST (SGOT) and ALT (SGPT) : 3 x upper limit of normal (ULN) (If there is Liver Metastasis : 5 x upper limit of normal (ULN))
• Total bilirubin : 1.5 x upper limit of normal (ULN)
• Provision of written informed consent prior to any study procedure

You may not qualify if:

• Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
• Any previous chemotherapy or immunotherapy within 2 weeks
• Any major operation or irradiation within 4 weeks of baseline disease assessment
• Two or more previous systemic cytotoxic chemotherapy (adjuvant chemotherapy is not counted)
• Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
• Previously taxol(paclitaxel)-exposed patients
• Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
• Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
• Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
• Pregnant or lactating female
• Patients with contraindicated medication
• History of interstitial lung disease (ILD) or presence of ILD on chest X-ray
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Afatinib; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Sun Young Rha

  Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 17, 2015
• Study Start: July 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 20, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

KR (1)