Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor (IOSI-NDU-001)
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|ClinicalTrials.gov Identifier: NCT02069158|
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : May 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer NSCLC Ovary Cancer Endometrial Cancer Small Cell Lung Cancer (SCLC) Head and Neck (HNSCC)||Drug: PF-05212384 Drug: Paclitaxel Drug: Carboplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DOSE FINDING STUDY OF PF-05212384 WITH PACLITAXEL AND CARBOPLATIN IN PATIENTS WITH ADVANCED SOLID TUMOR|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 2019|
Experimental: PF-05212384, Carboplatin, Paclitaxel
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
Other Name: Taxol
Other Name: no applicable
- dose limiting toxicity (DLT) [ Time Frame: 28 days after the first administration ]Assessment of the dose limiting toxicities (DLT) during first cycle
- Adverse Events [ Time Frame: minimum 8 weeks ]Adverse Event characterized by type, frequency and severity (as graded by NCICTCAE v. 4.03) during the treatment until progessive disease
- laboratory Adverse Events [ Time Frame: minimum 8 weeks ]Laboratory abnormalities characterized by type, frequency and severity (as graded by NCICTCAE v. 4.03) during all treatment until progressive disease
- Pharmacokintecs of PF-05212384 [ Time Frame: Cycle 1 day 1 and Cycle 2 day 1 ]Evaluation of the pharmacokinetic of PF-05212384 single agent or in combination with paclitaxel and carboplatin
- Tumor response [ Time Frame: every 8 weeks ]Objective tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST), RR, TTP
- biomarkers of pathway inhibition [ Time Frame: Day 1 of each cycle ]Serum glucose, and other circulating biomarkers of pathway inhibition (pS6K1)
- Pharmacodynamic [ Time Frame: Just before the treatment starts and cycle 1 day 22 ]Evaluation of the pharmacodynamic of biomarkers in tumor tissues (archived and fresh tumor biopsy)
- Gene expression [ Time Frame: Just before the treatment starts ]Gene expression in biopsied tumor tissues (fresh or archived) relating to PI3K and MAPK signaling
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069158
|Oncology Institute of Southern Switzerland (IOSI)|
|Bellinzona, TI, Switzerland, 6500|
|Principal Investigator:||Anastasios Stathis, Prof.||IOSI Sponsor Unit|