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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01283503
Collaborator
(none)
15
Enrollment
2
Locations
1
Arm
24
Duration (Months)
7.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: BKM120

Drug: BKM120

Outcome Measures

Primary Outcome Measures

  1. establish Maximum tolerate dose (MTD) [every day up to first 4 weeks]

Secondary Outcome Measures

  1. Safety assessed by type, frequency and severity of adverse events [Every week]

  2. Efficacy assessed by RECIST [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 [Every 2 weeks up to first 4 weeks, then every odd cycle]

  4. Measurement of biomarkers for PI3K pathway in blood and tissue [First 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. 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.

  2. At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors.

  3. Age ≥ 20 years

  4. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2

  5. Life expectancy of ≥ 12 weeks

  6. Patients must have the laboratory values

Exclusion Criteria:

  1. 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

  2. Prior treatment with a PI3K inhibitor

  3. Patients with any peripheral neuropathy ≥ CTCAE grade 2

  4. Patients with unresolved diarrhea ≥ CTCAE grade 2

  5. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Nagoya-city Aichi Japan 466-8560
2 Novartis Investigative Site Kashiwa Chiba Japan 277-8577

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01283503
Other Study ID Numbers:
  • CBKM120X1101
First Posted:
Jan 26, 2011
Last Update Posted:
Dec 8, 2020
Last Verified:
Apr 1, 2016
Keywords provided by Novartis Pharmaceuticals
PI3K,
Advanced solid tumor
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Dec 8, 2020