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A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas


Phase 1
20 Years
N/A
Not Enrolling
Both
Adenocarcinoma

Thank you

Trial Information

A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas


Inclusion Criteria:



- Has a histopathologically or cytologically confirmed diagnosis of gastric or
gastroesophageal junction adenocarcinoma

- Has an advanced or metastatic solid gastric adenocarcinoma that has failed standard
therapy

- Has resolution of all clinically significant toxic effects of prior therapy, surgery,
treatment with an investigational agent or device, treatment monoclonal antibody or
small molecule, and radiotherapy or chemotherapy.

- Has adequate organ function

- Eligible patients of reproductive potential (both sexes) agree to use adequate
contraceptive methods (hormonal or barrier methods) during the study period and for
12 weeks after the last dose of study medication

Exclusion Criteria:

- Has undergone major surgery within 28 days prior to the study, or subcutaneous venous
access device placement within 7 days prior to the study registration date

- Has elective or planned surgery to be conducted during the trial

- Has had treatment with an investigational agent or device, an antineoplastic small
molecule, or antineoplastic radiotherapy or chemotherapy

- Was previously treated with a chemotherapy regimen containing nitrosoureas or
mitomycin C

- Has had treatment with an antineoplastic monoclonal antibody within 8 weeks prior to
the study registration date

- Has a history of deep vein thrombosis, pulmonary embolism, or any other significant
thromboembolism prior to the study registration date

- Has experienced any arterial thrombotic event, including myocardial infarction,
cerebrovascular accident, or transient ischemic attack, within 6 months prior to the
study date

- Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin
or similar agents. (Patients receiving prophylactic, low-dose anticoagulation therapy
are eligible provided that the coagulation parameters INR ≤ 1.5, PT and PTT or - Is
receiving chronic therapy with nonsteroidal anti-inflammatory agents(Aspirin use at
doses up to 325 mg/day is permitted.)

- Has significant bleeding disorders, vasculitis, history of postoperative bleeding
complications, hemoptysis or had a significant bleeding episode from the GI tract
within 3 months prior to the study date

- Has a history of GI perforation and/or fistulae within 6 months prior to the study
date

- Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or
poorly controlled cardiac arrhythmia

- Has uncontrolled arterial hypertension despite standard medical management.

- Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days
prior to the study date

- Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive
intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea

- Has a serious illness or medical condition(s)

- Is pregnant or lactating

- Has received treatment with another investigational drug or participation in another
interventional clinical trial within 28 days prior to the study date

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with a Dose-Limiting Toxicity (DLT) during Cycle 1

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

Japan: Institutional Review Board

Study ID:

14204

NCT ID:

NCT01253525

Start Date:

December 2010

Completion Date:

October 2011

Related Keywords:

  • Adenocarcinoma
  • Adenocarcinoma
  • Gastroesophageal Junction
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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