Phase I/II Study Combining Tosedostat With Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma

Status: Terminated
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

There are two parts to this study: the goal of the first part of the study is to find the best dose of tosedostat when given in combination with capecitabine. The goal of the second part of the study is to look at how participants respond to treatment with tosedostat and capecitabine.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Histologically or cytologically proven metastatic or inoperable pancreatic adenocarcinoma.

• Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with CT scan or MRI, as >20 mm by chest x-ray, or >10 mm with calipers by clinical exam.

• Must have progressed on, been intolerant to, or refused gemcitabine-based therapy.

• At least 18 years of age.

• ECOG performance status ≤ 2

• Normal bone marrow and organ function as defined below:

• Absolute neutrophil count ≥ 1,000/mcl

• Platelets ≥ 100,000/mcl

• Total bilirubin ≤ 2.0 mg/dL

• Creatinine ≤ 2.0 mg/dL

• AST or ALT ≤2.5 IULN (≤5X IULN if liver metastases are present)

• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

• Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Locations
United States
Missouri
Washington University School of Medicine
Saint Louis
Time Frame
Start Date: August 31, 2015
Completion Date: October 19, 2018
Participants
Target number of participants: 16
Treatments
Experimental: Phase I (tosedostat + capecitabine)
The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.~Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.~Capecitabine 1000 mg/m^2 by mouth BID Days 1-14 of each 21-day cycle~Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
Experimental: Phase II (tosedostat + capecitabine)
Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle~Capecitabine by mouth BID Days 1-14 of each 21-day cycle
Authors
Joel Picus, Andrea Teague, Susan Hays, Shannon Grass, Anna Roshal, Andrea Wang-Gillam, Jan Hanneken, A. Craig Lockhart, Peter Oppelt, Rama Suresh, Alex Politsmakher, Benjamin Tan, Jane Sherman, Ashley Morton, Haeseong Park, Caron Rigden, Michael Naughton, Amber Smith, Kian-Huat Lim, Manik Amin
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov

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