Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors (SGI-0470-02)

Astex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Malignant Disease

Treatments: Drug: MP-470 + carboplatin/etoposide; Drug: MP-470 + docetaxel; Drug: MP-470 + erlotinib; Drug: MP-470 + topotecan; Drug: MP-470 + paclitaxel/carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881166

SGI-0470-02

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

101 participants in 5 patient groups

1

Experimental group

Description:

oral MP-470 + paclitaxel/carboplatin

Treatment:

Drug: MP-470 + paclitaxel/carboplatin

2

Experimental group

Description:

oral MP-470 + carboplatin/etoposide

Treatment:

Drug: MP-470 + carboplatin/etoposide

3

Experimental group

Description:

oral MP-470 + topotecan

Treatment:

Drug: MP-470 + topotecan

4

Experimental group

Description:

oral MP-470 + docetaxel

Treatment:

Drug: MP-470 + docetaxel

5

Experimental group

Description:

oral MP-470 + Erlotinib

Treatment:

Drug: MP-470 + erlotinib