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A Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors

Thank you

Trial Information

A Multi-Center, Phase 1/1b, Open-Label, Dose Escalation Study of ABT-700, a Monoclonal Antibody in Subjects With Advanced Solid Tumors


Inclusion Criteria:



- Subject with advanced solid tumors.

- Subject must have disease: a) that is not amenable to surgical resection, or b) that
has progressed or recurred despite standard therapy, or c) that has failed to respond
to standard therapy, or d) for which no effective therapy exists.

- Subject cannot tolerate or must not be eligible for other approved therapeutic
options with known survival advantage.

- Subjects enrolled on the combination therapy phase must satisfy the above inclusion
criteria and also the following: subjects must have inoperable, locally advanced or
metastatic Human Epidermal Growth Factor Receptor 2 (HER2) -negative
gastric/gastroesophageal junction adenocarcinoma with no prior therapy for metastatic
disease and be eligible to receive oxaliplatin and capecitabine (XELOX) in
combination with ABT-700.

Exclusion Criteria:

- Subject has received anticancer therapy including chemotherapy, immunotherapy,
radiation therapy, immunotherapy, biologic, or any investigational therapy within a
period of 21 days, or herbal therapy within 7 days prior to the first dose of
ABT-700.

- Palliative radiation therapy for painful bony or skin metastasis for 10 fractions or
less is not subject to a washout period.

- Subjects with uncontrolled metastases of the central nervous system. Subjects with
brain metastases are eligible provided they have shown clinical and radiographic
stable disease after definitive therapy and have not used steroids for at least 1
month prior to first dose of ABT-700.

- Subjects enrolled on the combination therapy phase must satisfy the above exclusion
criteria and also the following: subjects with inoperable, locally advanced or
metastatic gastric/gastroesophageal junction adenocarcinoma, who are ineligible to
receive XELOX chemotherapy, who are HER2+, or who have received prior chemotherapy
for metastatic disease will be excluded (adjuvant treatment with
chemotherapy/radiation therapy ≥ 6 months from Cycle 1 Day 1 is allowed).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of ABT-700 when administered as monotherapy and in combination with capecitabine/oxaliplatin (XELOX)

Outcome Description:

Evaluation of vital signs, clinical lab testing, physical exams and adverse event monitoring

Outcome Time Frame:

First cycle of treatment through 90 day follow-up visit

Safety Issue:

Yes

Principal Investigator

Louie Naumovski, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M12-375

NCT ID:

NCT01472016

Start Date:

October 2011

Completion Date:

August 2014

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms
  • MET amplification
  • c-Met overexpression
  • h224G11
  • Neoplasms

Name

Location

Site Reference ID/Investigator# 64046Scottsdale, Arizona  85258
Site Reference ID/Investigator# 57555Detroit, Michigan  48201
Site Reference ID/Investigator# 66111Durham, North Carolina  27710
Site Reference ID/Investigator# 66110Chicago, Illinois  60637-1470