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Completed

NCT Number: NCT01283503

A Study of BKM120 in Adult Japanese Patients With Advanced Solid Tumors

In this study, BKM120 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.

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Key information

Conditions

Advanced Solid Tumor

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
  • At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors.
  • Age ≥ 20 years
  • Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
  • Life expectancy of ≥ 12 weeks
  • Patients must have the laboratory values

Exclusion criteria

  • Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attribute to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
  • Prior treatment with a PI3K inhibitor
  • Patients with any peripheral neuropathy ≥ CTCAE grade 2
  • Patients with unresolved diarrhea ≥ CTCAE grade 2
  • Women of child-bearing potential who are pregnant or breast feeding. Men or women of reproductive potential not to sign informed consent for birth control. Barrier contraceptives must be used throughout the trial and six months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

BKM120

Drug

Primary outcomes

  1. establish Maximum tolerate dose (MTD)

    Time frame: every day up to first 4 weeks

Secondary outcomes

  1. Safety assessed by type, frequency and severity of adverse events

    Time frame: Every week

  2. Efficacy assessed by RECIST

    Time frame: Every 2 months

  3. Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples

    Time frame: Every 2 weeks up to first 4 weeks, then every odd cycle

  4. Measurement of biomarkers for PI3K pathway in blood and tissue

    Time frame: First 4 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2011
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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