Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor

Pfizer

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: Axitinib + Capecitabine (Cohort 6)

Drug: Axitinib + Gemcitabine + Cisplatin (Cohort 8)

Drug: Axitinib + Pemetrexed + Cisplatin (Cohort 9)

Drug: Axitinib + Docetaxel + Carboplatin (Cohort 4a)

Drug: Axitinib + Capecitabine (Cohort 7)

Drug: Axitinib + Docetaxel (Cohort 5)

Drug: Axitinib + Paclitaxel + Carboplatin (Cohort 2)

Drug: Axitinib + Paclitaxel (Cohort 4)

Drug: Axitinib + Paclitaxel + Carboplatin (Cohort 1)

Drug: Axitinib + Paclitaxel + Carboplatin (Cohort 3)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00454649

A4061019

Details and patient eligibility

About

To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Advanced solid tumors suitable for treatment with Taxanes, with or without carboplatin, or treatment with Capecitabine, Gemcitabine/Cisplatin. or Pemetrexed/Cisplatin

Exclusion criteria

Tumors abutting or providing support for blood vessels
Any significant gastrointestinal abnormalities or active bleeding.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 1 patient group

Axitinib [AG-013736] + chemotherapy combination

Experimental group

Description:

The following separate groups were included: axitinib 1. plus carboplatin/paclitaxel in three different schedules 2. plus paclitaxel 3. plus docetaxel/carboplatin 4. plus docetaxel 5. plus capecitabine 6. plus gemcitabine/cisplatin 7. plus pemetrexed/cisplatin

Treatment: