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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00894894

Solid Tumors

COMPLETED PHASE1

MP470 in Treating Patients With Unresectable or Metastatic Solid Tumor or Lymphoma

NCT00504205

Lymphoma Unspecified Adult Solid Tumor, Protocol Specific

TERMINATED NA

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411

NCT04101357

Solid Tumor Extensive-stage Small Cell Lung Cancer

TERMINATED PHASE1/PHASE2

Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications

NCT02649790

Relapsed/Refractory Multiple Myeloma (RRMM) Metastatic Colorectal Cancer (mCRC) Metastatic Castration-Resistant Prostate Cancer (mCRPC) +3 more

COMPLETED PHASE1/PHASE2

Combination Therapy With Oral 9-Nitrocamptothecin & Oral Etoposide

NCT00006047

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

oral MP-470 + paclitaxel/carboplatin

Group Type EXPERIMENTAL

MP-470 + paclitaxel/carboplatin

Intervention Type 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

2

oral MP-470 + carboplatin/etoposide

Group Type EXPERIMENTAL

MP-470 + carboplatin/etoposide

Intervention Type 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

3

oral MP-470 + topotecan

Group Type EXPERIMENTAL

MP-470 + topotecan

Intervention Type DRUG

Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5

4

oral MP-470 + docetaxel

Group Type EXPERIMENTAL

MP-470 + docetaxel

Intervention Type DRUG

Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1

5

oral MP-470 + Erlotinib

Group Type EXPERIMENTAL

MP-470 + erlotinib

Intervention Type DRUG

150 mg PO once daily at least 1 hour before or 2 hours after eating

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MP-470 + topotecan

Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5

Intervention Type DRUG

MP-470 + docetaxel

Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1

Intervention Type DRUG

MP-470 + erlotinib

150 mg PO once daily at least 1 hour before or 2 hours after eating

Intervention Type DRUG

MP-470 + paclitaxel/carboplatin

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

Intervention Type DRUG

MP-470 + carboplatin/etoposide

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Malignant disease appropriate for initiating treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel, or erlotinib.
2. Must be able to read, understand, and sign the IRB approved Informed Consent Form.
3. At least 18 years old.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.

Exclusion Criteria

1. Any other active invasive malignancy except non-melanoma skin cancers or cervical carcinoma in situ.
2. History of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure and/or myocardial infarction.
3. 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.
4. Received prior radiation therapy within the past 4 weeks.
5. Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.
6. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No