Solid TumorsPhase 1/2NCT00773344
Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin in Patients With Solid Tumors and Her2 Positive Metastatic Breast Cancer That Have Previously Failed Herceptin
A Phase 1/2 study testing Tanespimycin in people with Solid Tumors and Breast Cancer, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not previously responded to Herceptin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Breast Cancer
- What is being tested?
- Tanespimycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2005to Aug 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years
- KPS performance status >= 70%
- For the Phase 1 portion of the trial, all patients must have a histologically confirmed solid tumor malignancy. For the Phase 2 portion of the trial, patients must have metastatic breast cancer with HER2 amplification by FISH or 3+ HER2 overexpression by immunohistochemistry ("IHC") Patients may have had either progressive disease within 3 months following last dose of adjuvant treatment with trastuzumab OR progressive disease following initial therapy for metastatic disease with trastuzumab (trastuzumab may have been administered with cytotoxic chemotherapy, hormonal therapy or as single agent.) Patients who have received trastuzumab single agent therapy (without documented progressive disease) followed by trastuzumab combination therapy remain eligible for this study at the time of disease progression. Patients must have measurable disease by RECIST
- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade <= 2 (except for alopecia)
- The following laboratory results, within 10 days of KOS-953 administration:
- Hemoglobin >= 8.5 g/dL
Show all 12Show fewer
- Absolute neutrophils count >= 1.5 x 10*9* /L
- Platelet count >= 75 x 10*9* /L
- Serum bilirubin <= 2 x ULN
- AST and ALT <= 2 x ULN
- Serum creatinine <= 2 x ULN
- Signed informed consent
Who cannot join
- Documented hypersensitivity reaction of CTCAE Grade >= 3 to prior therapy containing Cremophor (for those patients who receive the Tanespimycin Injection only) or Herceptin
- Pregnant or breast-feeding women
- Known active CNS metastases
- Except for trastuzumab (Herceptin®) administered between 7-21 days prior to first tanespimycin (KOS-953) administration, administration of any other chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 14 days prior to receipt of study medication. Patients should be 6 weeks from last dose of nitrosourea
- Severe dyspnea at rest caused by complications of advanced malignancy or requiring supplementary oxygen therapy
- Congestive heart failure, or a left ventricular ejection fraction (LVEF) less than 50% assessed by multigated radionuclide angiography scan or echocardiography
- Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient
- Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin, carcinoma-in-situ of either the uterine cervix or urinary bladder, or Stage T1 or T2 prostate cancer whose PSA is < 2 ng/mL
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Premiere Oncology Of Arizona
Scottsdale, Arizona, 85260
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: Phase 1/2 Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin
The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not previously responded to Herceptin
- Conditions
- Solid Tumors, Breast Cancer
- Being tested
- Tanespimycin
- Keywords
- Solid Tumors (dose escalation/Phase 1), Breast Cancer (recommended dose phase/Phase 2)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TanespimycinDrug
Also called BMS-722782
Solution, IV, Weekly two hour infusion, 4-cycles until disease progression or DLT
This is a one-arm study with 4 fixed doses of Tanespimycin (225mg/m2, 300mg/m2, 375mg/m2 and 400mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: Tanespimycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response rate (RECIST complete response, or partial response ) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
Measured: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
Secondary outcomes (3)
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
Measured: 3-6 months
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
Measured: 6-12 months
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startDec 2005
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773344
- Sponsor's protocol ID
- CA200-001
- Other IDs
- KAG 122
- Status last verified
- Oct 2015
- First submitted
- 15 Oct 2008
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin
- ClinicalTrials.gov ID
- NCT00773344
- Acronym / sponsor ID
- CA200-001
- Conditions
- Solid Tumors, Breast Cancer
- Keywords
- Solid Tumors (dose escalation/Phase 1), Breast Cancer (recommended dose phase/Phase 2)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not previously responded to Herceptin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Tanespimycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >=18 years
- KPS performance status >= 70%
- For the Phase 1 portion of the trial, all patients must have a histologically confirmed solid tumor malignancy. For the Phase 2 portion of the trial, patients must have metastatic breast cancer with HER2 amplification by FISH or 3+ HER2 overexpression by immunohistochemistry ("IHC") Patients may have had either progressive disease within 3 months following last dose of adjuvant treatment with trastuzumab OR progressive disease following initial therapy for metastatic disease with trastuzumab (trastuzumab may have been administered with cytotoxic chemotherapy, hormonal therapy or as single agent.) Patients who have received trastuzumab single agent therapy (without documented progressive disease) followed by trastuzumab combination therapy remain eligible for this study at the time of disease progression. Patients must have measurable disease by RECIST
- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade <= 2 (except for alopecia)
- The following laboratory results, within 10 days of KOS-953 administration:
Key exclusion criteria (8 listed)
- Documented hypersensitivity reaction of CTCAE Grade >= 3 to prior therapy containing Cremophor (for those patients who receive the Tanespimycin Injection only) or Herceptin
- Pregnant or breast-feeding women
- Known active CNS metastases
- Except for trastuzumab (Herceptin®) administered between 7-21 days prior to first tanespimycin (KOS-953) administration, administration of any other chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 14 days prior to receipt of study medication. Patients should be 6 weeks from last dose of nitrosourea
- Severe dyspnea at rest caused by complications of advanced malignancy or requiring supplementary oxygen therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TanespimycinAlso: BMS-722782Solution, IV, Weekly two hour infusion, 4-cycles until disease progression or DLT This is a one-arm study with 4 fixed doses of Tanespimycin (225mg/m2, 300mg/m2, 375mg/m2 and 400mg/m2) | Drug | A1 |
Primary outcome
Objective tumor response rate (RECIST complete response, or partial response ) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
Time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
3 secondary outcomes
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
Time frame: 3-6 months
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
Time frame: 6-12 months
Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tanespimycin in people with Solid Tumors and Breast Cancer, run by Bristol-Myers Squibb at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor response rate (RECIST complete response, or partial response ) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions (time frame: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.