Clinical Trials Logo
  1. Home
  2. Gastric Adenocarcinoma
  3. NCT00073502
  4. Details
NCT00073502 Clinical Trial

Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer

Gastric Adenocarcinoma Clinical Trial

Official title:
A Phase II Study of Single Agent OSI-7904L In Patients With Locally Advanced or Metastatic Adenocarcinoma Of the Stomach or Gastroesophageal Junction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00073502
Other study ID # OSI-904-201
Secondary ID
Status Completed
Phase Phase 2
First received November 21, 2003
Last updated February 17, 2006
Start date October 2003
Est. completion date October 2003

Study information
Verified date October 2003
Source OSI Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date October 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Documented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No prior chemotherapy for locally advanced or metastatic disease Adequate baseline bone marrow, hepatic and renal function Age >= 18 years At least one target lesion

Exclusion Criteria:

Active or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• OSI-7904L

Locations
Country Name City State
Belgium Dept Internal Medicine Gastrointestinal Oncology Unit B-3000 Leuven
United Kingdom NICCTU, East Podium, C-Floor Belfast
United Kingdom Bristol Haematology & Oncology Centre Bristol Avon
United Kingdom Beatson Oncology Centre Glasgow
United Kingdom Cookridge Hospital Leeds
United Kingdom Department of Medical Oncology Manchester
United Kingdom ICRF Medical Oncology Unit Oxford Oxfordshire
United Kingdom Deanesly Centre Wolverhampton West Midlands
United States MD Anderson Cancer Center Houston Texas
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States University of Utah, Huntsman Cancer Institute Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
OSI Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  United Kingdom, 

See also
  Status Clinical Trial Phase
Recruiting NCT05977998 - A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology Phase 2
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT03257163 - Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer Phase 2
Completed NCT02128243 - Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer Phase 2
Completed NCT01178944 - Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer Phase 2
Terminated NCT00209079 - Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma Phase 2
Terminated NCT02862535 - Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma Phase 1
Active, not recruiting NCT05008783 - A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma Phase 3
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Recruiting NCT04114136 - Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies Phase 2
Completed NCT03196232 - Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer Phase 2
Recruiting NCT04047953 - Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma N/A
Completed NCT02891447 - Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer Phase 2
Completed NCT02864381 - Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Phase 2
Terminated NCT04032704 - A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors Phase 2
Terminated NCT04604132 - Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma Phase 1/Phase 2
Completed NCT02830594 - Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer Phase 2
Recruiting NCT06038578 - A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer Phase 2
Terminated NCT04099277 - A Study of LY3435151 in Participants With Solid Tumors Phase 1