Clinical trial · Interventional
Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer
A Phase 2 Study of AZD0530 in Patients With Metastatic or Locally Advanced Gastric Carcinoma
NCT00607594CI-TRIAL-00034538completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Gastroesophageal Junction | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Stomach | Gastric Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stage III Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stage IV Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| saracatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (kinase inhibitor therapy)
- description
- Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: saracatinib
Primary outcomes (2)
- measure
- Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)
- timeFrame
- Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks
- description
- 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.
- measure
- Prolonged Stable Disease Rate (Defined as Stable Disease for ≥ 16 Weeks)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Urine protein creatinine ratio \< 1.0 OR urine protein \< 1,000 mg by 24-hour urine collection Exclusion Criteria: * 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: * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * No other concurrent uncontrolled illness, including ongoing or active infection or psychiatric illness/social situations, that would limit compliance with study requirements * Prior chemotherapy allowed provided it was administered as part of initial curative intent therapy (i.e., neoadjuvant therapy, adjuvant therapy and/or concurrently with radiotherapy) in combination with surgery * At least 4 weeks since prior chemotherapy * At least 4 weeks since prior and no more than 1 line of palliative chemotherapy for advanced disease * At least 4 weeks since prior radiotherapy and recovered * At least 4 weeks since prior major surgery and recovered * No cytochrome 450 3A4 (CYP3A4) active agents or substances for ≥ 7 days before, during, and for ≥ 7 days after completion of study treatment * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.