Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Sunitinib

Imatinib Mesylate

Xylometazoline

Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.

Ganetespib 200 mg/m\^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week. Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.

Ganetespib

The purpose of this study is to determine if STA-9090 is effective in the treatment of patients with metastatic and/or unresectable GIST.

Planned:

* Stage 1: 23 patients. If ≥4 patients had clinical benefit, an additional 32 patients were to be enrolled. Up to 3 additional patients with platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) mutation were to be enrolled, regardless of the total study enrollment.
* Stage 2: 55 patients. Progressing to this stage was dependent on Stage 1 results.

Analyzed:

* Stage 1: 27 patients were enrolled and analyzed. The study was not expanded to Stage 2 due to insufficient efficacy.

A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)

A Non-randomized, Open Label, Multi-center Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Patients With Metastatic and/or Unresectable GIST Resistant or Refractory to Prior Systemic Treatments Including Imatinib and Sunitinib

Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.

* CR: disappearance of all target lesions and non-target lesions and no new lesions
* PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions
* SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions

Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.

* CR: disappearance of all target lesions and non-target lesions and no new lesions
* PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions

PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as

* at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or
* the appearance of 1 or more new lesions or
* the unequivocal progression of existing nontarget lesions

Overall survival was defined as the time from first dose to death or the date last known alive.

PET imaging was completed on selected patients only from one investigative site. Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10. PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines \[Young H, Eur J Cancer, 1999\]. Tumor response was considered a complete response (CR) or a partial response (PR).

Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:

Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death

A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.

Dose modification includes dose delay and dose reduction.

Synta Pharmaceuticals Corp.

Ganetespib 200 mg/m^2

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Weight

Height

Body Surface Area (BSA)

Time from Initial Gastrointestinal Stromal Tumor (GIST) Diagnosis to Consent

N = 20 participants GIST = gastrointestinal stromal tumor

Time from Metastatic/Unresectable GIST Diagnosis to Consent

The ECOG scale is as follows:

* Grade 0: Fully active, able to carry on all pre-disease activities without restriction;
* Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
* Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours;
* Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours;
* Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Unknown

Any Prior Exposure to Heat Shock Protein 90 (HSP90) Inhibitors

Prior Systemic Treatment for GIST

Number of Prior Systemic Treatment Regimens for GIST

Complete response

Partial response

Stable Disease

Progressive disease

Target Lesion Response Criteria, RECIST (version 1.0)

* Complete response - disappearance of all target lesions
* Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions
* Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease
* Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions

Best Response From Prior Systemic Treatment

Full analysis set, which includes participants given at least one dose of study medication.

VP Clinical Research

Full analysis set which included participants receiving at least one dose of study medication.

Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0

Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0

Kaplan-Meier Estimate of Progression Free Survival (PFS)

Kaplan-Meier Estimate of Overall Survival

Participants from one investigative site who provided consent for the PET/CT imaging.

Spots Global Cancer Trial Database for A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial