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Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors

NCT02439489 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-06-20

No results posted yet for this study

Summary

PI3K signaling is a hallmark of many cancers. Subsets of cancers become dependent on PI3K pathway signaling as a result of mutations of the PIK3CA gene itself or of regulators of PI3K (e.g. PTEN, HER2). As a consequence, pathway mutated tumors are particularly sensitive towards PI3K-pathway inhibition. BKM120 is a potent and highly specific oral pan-class I PI3K-inhibitor.

The study FM-11-F01b is a phase Ib single institution study using the combination of BKM120 and cisplatin or carboplatin in patient with pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated (preferentially head and neck, NSCLC, ovary, endometrial).

The primary objective of the study is to define the phase II recommended dose of daily oral BKM120 and cisplatin (Group 1) or carboplatin (Group 2), given intravenously (IV) on day 1 every 3 weeks.

Conditions

Interventions

DRUG

BKM120-CIS

BKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Cisplatin will be delivered intravenously at the dose of 75 mg/m2 on day 1 every 3 weeks at each dose level of BKM120. In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity

DRUG

BKM120-CARBO

BKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Carboplatin will be delivered intravenously at AUC 5 on day 1 every 3 weeks at each dose level of BKM120. Should dose level 3 be completed, carboplatin will be given at AUC 6 and BKM120 at 100 mg. In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity

Sponsors & Collaborators

  • Fondazione Michelangelo

    lead OTHER

Principal Investigators

  • Luca Gianni, MD · Ospedale San Raffaele

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2017-06-09
Completion
2017-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02439489 on ClinicalTrials.gov