Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors
SGI-0470-02
Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens
1 other identifier
interventional
101
1 country
5
Brief Summary
Adult subjects with malignant disease appropriate for treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel or erlotinib according to the standard dosing regimen will be enrolled in each treatment arm. Primary objective: Determine the MTD. Secondary objectives: Response rates, PK, quantify MP-470 on PK of SOC, and collect pharmacodynamic information. Evaluate the overall safety of MP-470 when co-administered with specific SOC treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2007
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 13, 2009
CompletedFirst Posted
Study publicly available on registry
April 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 2, 2024
August 1, 2024
2.1 years
April 13, 2009
August 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD)
March 2010
Secondary Outcomes (3)
Response rate
March 2010
Pharmacokinetics, pharmacodynamic effects on biomarker modulation.
March 2010
Experience DLT
March 2010
Study Arms (5)
1
EXPERIMENTALoral MP-470 + paclitaxel/carboplatin
2
EXPERIMENTALoral MP-470 + carboplatin/etoposide
3
EXPERIMENTALoral MP-470 + topotecan
4
EXPERIMENTALoral MP-470 + docetaxel
5
EXPERIMENTALoral MP-470 + Erlotinib
Interventions
Paclitaxel 200 mg/m2 IV infusion over 3 hours followed by carboplatin IV infusion over 1 hour to a target AUC of 6 mg∙min/mL on Day 1
Carboplatin IV infusion over 1 hour to target AUC of 5 mg min/mL on Day 1 followed by etoposide 100 mg/m2 IV infusion over 2 hours on Days 1-3
Eligibility Criteria
You may qualify if:
- Malignant disease appropriate for initiating treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel, or erlotinib.
- Must be able to read, understand, and sign the IRB approved Informed Consent Form.
- At least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.
You may not qualify if:
- Any other active invasive malignancy except non-melanoma skin cancers or cervical carcinoma in situ.
- History of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure and/or myocardial infarction.
- Received any anticancer agent(s) within the past 3 weeks, including investigational agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic or hormonal therapy other than LHRH agonists.
- Received prior radiation therapy within the past 4 weeks.
- Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.
- Patient requires treatment with immunosuppressive agents other than corticosteroids appropriate for the SOC chemotherapy regimen or those at stable doses for at least 2 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Premiere Oncology
Scottsdale, Arizona, 85258, United States
Premiere Oncology
Santa Monica, California, 90404, United States
Audie Murphy Veterans Memorial Hospital (VA)
San Antonio, Texas, 78229, United States
CTRC at the UT Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
South Texas Accelerated Research Therapy (START)
San Antonio, Texas, 78229, United States
Related Publications (1)
Mita M, Gordon M, Rosen L, Kapoor N, Choy G, Redkar S, Taverna P, Oganesian A, Sahai A, Azab M, Bristow R, Tolcher AW. Phase 1B study of amuvatinib in combination with five standard cancer therapies in adults with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Jul;74(1):195-204. doi: 10.1007/s00280-014-2481-1. Epub 2014 May 22.
PMID: 24849582DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2009
First Posted
April 15, 2009
Study Start
November 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 2, 2024
Record last verified: 2024-08