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Solid TumorsPhase 1NCT00894894

Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of Oral MP470, a Multitargeted Tyrosine Kinase Inhibitor, in Patients With Solid Malignancies

A Phase 1 study testing MP-470 and amuvatinib (MP-470) in people with Solid Tumors, run by Astex Pharmaceuticals, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multicenter, open-label, dose-ranging study in two parts: maximum tolerated dose (MTD) segment (the first 28-day course of MP 470) followed by long-term safety segment. MTD segment: follows standard oncology phase-I design; within-patient dose level adjustments prohibited; each patient participates in one of three… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Solid Tumors
What is being tested?
MP-470 and amuvatinib (MP-470)
How many people
22 participants
Where
2 sitesUnited States
Study dates
May 2007to Dec 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has a histological or cytological diagnosis of unresectable or metastatic solid-tumor cancer that is refractory to standard therapies or for which no standard therapy exists. Patients with refractory lymphoma (Hodgkin's or NHL) are also permitted to participate.
  • The patient must read, understand and sign the IRB-approved informed consent form (ICF) confirming his or her willingness to participate in this trial.
  • The patient is willing and able to participate in all of the required evaluations and procedures described in this study protocol, including swallowing MP 470 capsules.
  • The patient is at least 18 years old.
  • The patient is capable of fasting for 6 hours.
  • The patient has Karnofsky Performance Status ≥ 70 (see Appendix 5).
Show all 13Show fewer
  • The patient has adequate bone marrow function evidenced, at minimum, by Hgb ≥ 9 g/dL, ANC ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L.
  • The patient has normal renal and hepatic function evidenced, at minimum, by total serum bilirubin ≤ 2 mg/dL; AST and ALT ≤ 2.5 x ULN (upper limit of normal for the clinical laboratory), but ≤ 5 x ULN is acceptable if due to hepatic metastases; serum albumin ≥ 2 g/dL; and serum creatinine ≤ 2 mg/dL.
  • The patient has normal cardiac function in the opinion of the investigator and supported by left ventricular ejection fraction (LVEF) 50% or greater on the screening echocardiogram, no significant abnormalities on the screening ECG (eg, left bundle branch block, III degree AV block, acute myocardial infarction or QTc interval > 450 msec) and no history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia or family history of Long QT Syndrome).
  • The patient has recuperated from any prior surgical procedures including at least 4 weeks rest since a major surgery.
  • The patient does not have childbearing potential or has had a negative serum pregnancy test within the past 14 days.
  • The patient does not have reproductive potential or has agreed to use and will use an approved method of contraception during the study and for 3 months following the last dose of MP 470.
  • The patient is not lactating.

Who cannot join

  • The patient has a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of oral MP 470, or put the study outcomes at risk.
  • The patient has any serious, uncontrolled active infection that requires systemic treatment.
  • The patient has a history of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure and/or myocardial infarction.
  • The patient has 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.
  • The patient has received radiation therapy within the past 4 weeks.
  • The patient has a grade-2 or more severe toxicity (other than alopecia) continuing from prior anticancer therapy.
  • The patient has active CNS metastases (primary brain tumors are permitted).
  • The patient requires treatment with immunosuppressive agents other than corticosteroids that have been at stable doses for at least 2 weeks.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • So. Texas Accelerated Research Therapeutics-START

    San Antonio, Texas, 78229

  • Translation Genomics Research Institute (TGen)/Scottsdale Clin.Researc

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Multicenter, open-label, dose-ranging study in two parts: maximum tolerated dose (MTD) segment (the first 28-day course of MP 470) followed by long-term safety segment.

MTD segment: follows standard oncology phase-I design; within-patient dose level adjustments prohibited; each patient participates in one of three stages:

  1. Accelerated Titration Stage
  2. Dose Escalation/De-Escalation Stage
  3. Dose Confirmation Stage
Read the detailed description

Multicenter, open-label, dose-ranging study in two parts: MTD Segment (the first 28-day course of MP 470) followed by Long-Term Safety Segment

MTD Segment: follows standard oncology phase-I design; within-patient dose level adjustments prohibited; each patient participates in one of three stages:

Accelerated Titration Stage: 1 patient per dose level; first patient receives MP 470 at 100 mg/day; subsequent patients assigned higher dose levels based on modified Fibonacci sequence; stage stops when any first-course DLT is observed or when grade-2 or greater MP 470-related toxicity is observed at 2 dose levels; dosing next patient prohibited until previous patient's MTD-Segment result is confirmed Dose Escalation/De-Escalation Stage: 3 patients per cohort; two additional patients enrolled to receive last dose level studied during Accelerated Titration Stage (first 3-patient cohort); subsequent 3-patient cohorts assigned dose level conditional on number of patients with first-course DLT in previous cohort; new cohorts enrolled until MTD is defined; dosing next cohort prohibited until previous cohort's MTD-Segment results are confirmed Dose Confirmation Stage: an additional 6-10 patients enrolled to receive MP 470 at the established MTD; patient accrual stops following Dose Confirmation Long-Term Safety Segment: patients continue receiving 28-day courses of MP 470 until experiencing unmanageable toxicity or disease progression; within-patient dose level adjustments based on toxicity; DLT during preceding 28-day course mandates one-level dose reduction; one-level dose increase possible in absence of grade-3 or greater MP 470-related AEs during preceding 28-day course

Conditions
Solid Tumors
Being tested
MP-470, amuvatinib (MP-470)
Keywords
MP470, MP-470, SuperGen, Tyrosine, Kinase, Inhibitor, Solid Malignancies, Oncology
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MP-470Drug

    Also called amuvatinib

    escalating daily doses of amuvatinib

  • amuvatinib (MP-470)Drug

    escalating doses of daily amuvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2009 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00894894
Sponsor's protocol ID
SGI-0470-01
Status last verified
Aug 2024
First submitted
5 May 2009
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
No

Publications

  • Tibes R, Fine G, Choy G, Redkar S, Taverna P, Oganesian A, Sahai A, Azab M, Tolcher AW. A phase I, first-in-human dose-escalation study of amuvatinib, a multi-targeted tyrosine kinase inhibitor, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2013 Feb;71(2):463-71. doi: 10.1007/s00280-012-2019-3. Epub 2012 Nov 23.

    PubMed 23178951

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MP-470 and amuvatinib (MP-470) in people with Solid Tumors, run by Astex Pharmaceuticals, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00894894, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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