Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer

NCT00607594 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2009-00188PHL-052CDR0000585708PMH-PHL-052N01CM62203
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 5

Brief Summary

This phase II trial is studying how well saracatinib works in treating patients with locally advanced or metastatic stomach or gastroesophageal junction cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage III Gastric Cancer; Stage III Esophageal Cancer; Stage IV Esophageal Cancer; Stage IV Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)

  PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR is defined as disappearance of all non-target lesions and normalization of tumor marker level.

  Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks

• Prolonged Stable Disease Rate (Defined as Stable Disease for ≥ 16 Weeks)

  Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks

Secondary Outcomes (7)

• Time to Progression

  Up to 1 year (median, 6 month, 1-year)

• Progression-free Survival

  Measured from the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy

• Median Survival

  Up to 1 year

• Overall Survival

  Up to 1 year (median, 6 months, and 1 year)

• Highest Grade Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.

  Weekly during treatment

Study Arms (1)

Treatment (kinase inhibitor therapy)

EXPERIMENTAL

Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.

Drug: saracatinib

Interventions

saracatinib DRUG

Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity.

Also known as: AZD0530

Treatment (kinase inhibitor therapy)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ)
• Tumors of the GEJ must be sub-specified as type I, II, or III using the Siewert classification
• Metastatic or locally advanced disease
• Patients with local/regional disease only, must have unresectable disease
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral computed tomography (CT) scan
• No known brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy \> 3 months
• Platelet count ≥ 100,000/mm³
• Leukocytes ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Hemoglobin \> 9 g/dL
• Total bilirubin normal
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min

You may not qualify if:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No condition that potentially impairs the ability to swallow or absorb AZD0530, including any of the following:
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
• Active peptic ulcer disease
• Short gut syndrome
• Malabsorption syndrome of any type
• Total or partial bowel obstruction
• Inability to tolerate oral medications
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530
• No QTc prolongation (defined as a QTc interval ≥ 460 msec) or other significant electrocardiogram (ECG) abnormalities
• No poorly controlled hypertension (i.e., systolic blood pressure \[BP\] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
• No history of ischemic heart disease, including myocardial infarction
• No concurrent cardiac dysfunction including, but not limited to, any of the following:

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (5)

Hamilton Medical Center

Dalton, Georgia, 30720, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Interventions

saracatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Results Point of Contact

• Title: Dr. Heather-Jane Au
• Organization: Cross Cancer Institute

heathera@cancerboard.ab.ca

780-432-8500

Study Officials

• Heather-Jane Au

  University Health Network-Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2012
• Last Updated: August 23, 2018
• Results First Posted: July 18, 2014

Record last verified: 2018-07

Locations

CA (4); US (1)