Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | oral MP-470 + paclitaxel/carboplatin |
|
| 2 | Experimental | oral MP-470 + carboplatin/etoposide |
|
| 3 | Experimental | oral MP-470 + topotecan |
|
| 4 | Experimental | oral MP-470 + docetaxel |
|
| 5 | Experimental | oral MP-470 + Erlotinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-470 + topotecan | Drug | Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | March 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | March 2010 | |
| Pharmacokinetics, pharmacodynamic effects on biomarker modulation. | March 2010 | |
| Experience DLT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premiere Oncology | Scottsdale | Arizona | 85258 | United States | ||
| Premiere Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24849582 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MP-470 + docetaxel |
| Drug |
Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1 |
|
| MP-470 + erlotinib | Drug | 150 mg PO once daily at least 1 hour before or 2 hours after eating |
|
| MP-470 + paclitaxel/carboplatin | Drug | 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/etoposide | Drug | 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 |
|
| March 2010 |
| 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 |
| ID | Term |
|---|---|
| C521047 | amuvatinib |
| D019772 | Topotecan |
| D000077143 | Docetaxel |
| D000069347 | Erlotinib Hydrochloride |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D056831 | Coordination Complexes |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided