A Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors

NCT00879905 | Completed Phase 1

• 2 other identifiers: CHSP990A21012008-006440-19
• Study Type: interventional
• Target: 64
• Locations: 3 countries
• Sites: 3

Brief Summary

This study will study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors.

Conditions

Advanced Solid Malignancies

Keywords

Phase I; Adults; HSP990; Advanced Solid Tumors; Hsp90 inhibitor; Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of HSP990 in patients treated once weekly or twice weekly

  At the end of the dose escalation phase of the study

Secondary Outcomes (3)

• True DLT rate

  At the end of the 1st 4 weeks of treatment

• Preliminary Efficacy

  Every 2 months (or 8 weeks, which equals 2 treatment cycles)

• Drug metabolism in Humans, PK, PD

  every 4 weeks

Study Arms (2)

once weekly dosing schedule

EXPERIMENTAL

Drug: HSP990

twice weekly dosing schedule

EXPERIMENTAL

Drug: HSP990

Interventions

HSP990 DRUG

once weekly dosing schedule; twice weekly dosing schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists
• All patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression
• All patients must have documented progressive disease before entering the study
• Age ≥ 18 years
• World Health Organization (WHO) Performance Status ≤ 2
• Life expectancy of ≥ 12 weeks
• Patients must have the certain laboratory values
• Patients able and willing to swallow capsules
• Ability to understand the patient information and informed consent form and comply with the protocol
• Signed and dated written informed consent is available
• Only for patients enrolled at MTD: willing to provide a fresh pre-dose and post-dose tumor biopsy.

You may not qualify if:

• Patients with present or history of CNS metastasis.
• Prior treatment with any Hsp90 or HDAC inhibitor compound.
• Patients who have not recovered from side effects of previous systemic anticancer therapy to \< CTCAE Grade 2 prior to the first dose
• Patients identified to be "poor or intermediate CYP2C9 metabolizers"
• Patients who received systemic anti-cancer treatment prior to the first dose of HSP990 within the following time frames:
• Patients who have received cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C) prior to starting study drug or who have not recovered from the side effects of such therapy
• Patients who have received biologic therapy (e.g., antibodies) within a period of time that is ≤ 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy
• Patients who have been treated with a continuous or intermittent small molecule therapeutic within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy
• Patients who have received any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy
• Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
• Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
• Treatment with therapeutic doses of sodium warfarin (Coumadin).
• Patients using medications that are CYP2C9 inhibitors and/or medications known to have QT prolongation effect and cannot be switched or discontinued to an alternative drug prior to commencing HSP990 dosing.
• Unresolved diarrhea ≥ CTCAE grade 2
• Patients who do not have either an archival tumor sample available or readily obtainable in the course of the study or are unwilling to have a fresh tumor sample collected at baseline.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Toulouse, 31052, France

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Related Links

• Results for CHSP990A2101 can be found on the Novartis Clinical Trials Results Website

MeSH Terms

Conditions

Neoplasms

Interventions

2-amino-7-(4-fluoro-2-(6-methoxypyridin-2-yl)phenyl)-4-methyl-7,8-dihydropyrido(4,3-d)pyrimidin-5(6H)-one

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: April 13, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 8, 2020

Record last verified: 2012-10

Locations

ES (1); FR (1); CA (1)