Malignant DiseasePhase 1SGI-0470-02NCT00881166
Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors
A Phase 1 study testing MP-470 + topotecan, MP-470 + docetaxel and MP-470 + erlotinib in people with Malignant Disease, run by Astex Pharmaceuticals, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Disease
- What is being tested?
- MP-470 + topotecan, MP-470 + docetaxel and MP-470 + erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2007to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Audie Murphy Veterans Memorial Hospital (VA)
San Antonio, Texas, 78229
CTRC at the UT Health Science Center at San Antonio
San Antonio, Texas, 78229
South Texas Accelerated Research Therapy (START)
San Antonio, Texas, 78229
Premiere Oncology
Santa Monica, California, 90404
Premiere Oncology
Scottsdale, Arizona, 85258
About this study
Official title: Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens
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.
- Conditions
- Malignant Disease
- Being tested
- MP-470 + topotecan, MP-470 + docetaxel, MP-470 + erlotinib, MP-470 + paclitaxel/carboplatin, MP-470 + carboplatin/etoposide
- Keywords
- MP-470, Multi-targeted Tyrosine Kinase Inhibitor, Malignant disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP-470 + topotecanDrug
Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5
MP-470 + docetaxelDrug
Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1
MP-470 + erlotinibDrug
150 mg PO once daily at least 1 hour before or 2 hours after eating
MP-470 + paclitaxel/carboplatinDrug
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
MP-470 + carboplatin/etoposideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | oral MP-470 + paclitaxel/carboplatin Receives: Drug: MP-470 + paclitaxel/carboplatin |
| 2 | Experimental | oral MP-470 + carboplatin/etoposide Receives: Drug: MP-470 + carboplatin/etoposide |
| 3 | Experimental | oral MP-470 + topotecan Receives: Drug: MP-470 + topotecan |
| 4 | Experimental | oral MP-470 + docetaxel Receives: Drug: MP-470 + docetaxel |
| 5 | Experimental | oral MP-470 + Erlotinib Receives: Drug: MP-470 + erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: March 2010
Secondary outcomes (3)
Response rate
Measured: March 2010
Pharmacokinetics, pharmacodynamic effects on biomarker modulation.
Measured: March 2010
Experience DLT
Measured: March 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881166
- Sponsor's protocol ID
- SGI-0470-02
- Acronym
- SGI-0470-02
- Status last verified
- Aug 2024
- First submitted
- 13 Apr 2009
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24849582
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens
- ClinicalTrials.gov ID
- NCT00881166
- Acronym / sponsor ID
- SGI-0470-02 / SGI-0470-02
- Conditions
- Malignant Disease
- Keywords
- MP-470, Multi-targeted Tyrosine Kinase Inhibitor, Malignant disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MP-470 + paclitaxel/carboplatinoral MP-470 + paclitaxel/carboplatin |
| 2 | Experimental | Drug: MP-470 + carboplatin/etoposideoral MP-470 + carboplatin/etoposide |
| 3 | Experimental | Drug: MP-470 + topotecanoral MP-470 + topotecan |
| 4 | Experimental | Drug: MP-470 + docetaxeloral MP-470 + docetaxel |
| 5 | Experimental | Drug: MP-470 + erlotiniboral MP-470 + Erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MP-470 + topotecanTopotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5 | Drug | 3 |
| MP-470 + docetaxelDocetaxel 75 mg/m2 IV infusion over 1 hour on Day 1 | Drug | 4 |
| MP-470 + erlotinib150 mg PO once daily at least 1 hour before or 2 hours after eating | Drug | 5 |
| MP-470 + paclitaxel/carboplatinPaclitaxel 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 | Drug | 1 |
| MP-470 + carboplatin/etoposideCarboplatin 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 | Drug | 2 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: March 2010
3 secondary outcomes
Response rate
Time frame: March 2010
Pharmacokinetics, pharmacodynamic effects on biomarker modulation.
Time frame: March 2010
Experience DLT
Time frame: March 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Derived from this study: PubMed 24849582Mita 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MP-470 + topotecan, MP-470 + docetaxel and MP-470 + erlotinib in people with Malignant Disease, run by Astex Pharmaceuticals, Inc. at 5 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 5 inclusion and 6 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 5 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?
Maximum tolerated dose (MTD) (time frame: March 2010). 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 NCT00881166, 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.