Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors

Conditions

• Malignant Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MP-470 + topotecan — DRUG
  Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5
• 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

Study Details

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.

Key Dates

First listed

Apr 15, 2009

Start date

Nov 30, 2007

Status verified

Aug 2024

Primary completion

Dec 31, 2009

Completion

Dec 31, 2009

Study Design

Enrollment

101 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
  oral MP-470 + paclitaxel/carboplatin
• Experimental: 2
  oral MP-470 + carboplatin/etoposide
• Experimental: 3
  oral MP-470 + topotecan
• Experimental: 4
  oral MP-470 + docetaxel
• Experimental: 5
  oral MP-470 + Erlotinib

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: March 2010 ]

Locations (5)

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