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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02069158
Other study ID # IOSI-NDU-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2014
Est. completion date May 2019

Study information

Verified date May 2019
Source Oncology Institute of Southern Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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Study Design


Intervention

Drug:
PF-05212384
iv administrartion
Paclitaxel
iv administration
Carboplatin
iv administration

Locations

Country Name City State
Switzerland Oncology Institute of Southern Switzerland (IOSI) Bellinzona TI

Sponsors (1)

Lead Sponsor Collaborator
Cristiana Sessa

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary dose limiting toxicity (DLT) Assessment of the dose limiting toxicities (DLT) during first cycle 28 days after the first administration
Primary Adverse Events Adverse Event characterized by type, frequency and severity (as graded by NCICTCAE v. 4.03) during the treatment until progessive disease minimum 8 weeks
Primary laboratory Adverse Events Laboratory abnormalities characterized by type, frequency and severity (as graded by NCICTCAE v. 4.03) during all treatment until progressive disease minimum 8 weeks
Secondary Pharmacokintecs of PF-05212384 Evaluation of the pharmacokinetic of PF-05212384 single agent or in combination with paclitaxel and carboplatin Cycle 1 day 1 and Cycle 2 day 1
Secondary Tumor response Objective tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST), RR, TTP every 8 weeks
Secondary biomarkers of pathway inhibition Serum glucose, and other circulating biomarkers of pathway inhibition (pS6K1) Day 1 of each cycle
Secondary Pharmacodynamic Evaluation of the pharmacodynamic of biomarkers in tumor tissues (archived and fresh tumor biopsy) Just before the treatment starts and cycle 1 day 22
Secondary Gene expression Gene expression in biopsied tumor tissues (fresh or archived) relating to PI3K and MAPK signaling Just before the treatment starts
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