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Paclitaxel

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starting dose of PF-05212384: 95 mg iv weekly Dose of Carboplatin: 5 AUC every 28 days Dose of Paclitaxel: 80 mg/m2 on days 1, 8 and 15

PF-05212384

Anastasios Stathis, Prof.

This is a phase Ib single arm, open-label, multiple dose, dose escalating, safety, pharmacokinetic and pharmacodynamic study of the combination of PF-05212384 with paclitaxel and carboplatin. The study will be conducted in adult patients with advanced breast, NSCLC, ovarian or endometrial, small cell lung cancer (SCLC) and Head and Neck (HNSCC) cancer for whom there is an indication to the use of paclitaxel and carboplatin.

Successive cohorts of patients will receive escalating doses of PF-05212384 in combination with paclitaxel and carboplatin, starting at a dose level determined to be the 60% of single agent MTD.

The study will consist of two parts: the dose finding part (Part 1) and the expansion part (Part 2).

During Part 1 patients with breast, NSCLC, ovary and endometrial, small cell lung cancer (SCLC) and Head and Neck (HNSCC) cancer will be enrolled.

During Part 2, only patients with ovarian cancer will be enrolled. In Part 1, a 3+3 design is employed. Once the MTD of the combination is defined in Part 1, Part 2 is performed for a better definition of the safety profile, of the potential antitumor activity and of the pharmacodynamic effects of the combination; it will be conducted in at least 12 patients with ovarian cancer.

Approximately 40 patients are expected to be enrolled in the study overall.

Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor

DOSE FINDING STUDY OF PF-05212384 WITH PACLITAXEL AND CARBOPLATIN IN PATIENTS WITH ADVANCED SOLID TUMOR

Assessment of the dose limiting toxicities (DLT) during first cycle

Adverse Event characterized by type, frequency and severity (as graded by NCICTCAE v. 4.03) during the treatment until progessive disease

Laboratory abnormalities characterized by type, frequency and severity (as graded by NCICTCAE v. 4.03) during all treatment until progressive disease

Evaluation of the pharmacokinetic of PF-05212384 single agent or in combination with paclitaxel and carboplatin

Objective tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST), RR, TTP

Serum glucose, and other circulating biomarkers of pathway inhibition (pS6K1)

Evaluation of the pharmacodynamic of biomarkers in tumor tissues (archived and fresh tumor biopsy)

Gene expression in biopsied tumor tissues (fresh or archived) relating to PI3K and MAPK signaling

Cristiana Sessa

Prof.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor	NCT02069158	Breast Cancer NSCLC Ovary Cancer Endometrial Can... Small Cell Lung... Head and Neck (...	PF-05212384 Paclitaxel Carboplatin	18 Years -	Oncology Institute of Southern Switzerland
Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor	NCT02069158	Breast Cancer NSCLC Ovary Cancer Endometrial Can... Small Cell Lung... Head and Neck (...	PF-05212384 Paclitaxel Carboplatin	18 Years -	Oncology Institute of Southern Switzerland

Spots Global Cancer Trial Database for head and neck (hnscc)