Adult Solid NeoplasmPhase 1NCT01276496
Weekly Doses of Cilengitide and Paclitaxel in Treating Patients With Advanced Solid Tumors That Cannot Be Removed by Surgery
A Phase 1 study testing Cilengitide, Laboratory Biomarker Analysis and Paclitaxel in people with Adult Solid Neoplasm and Estrogen Receptor Negative, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial summary
This phase I trial studies the side effects and the best dose of cilengitide when given together with paclitaxel weekly in treating patients with solid tumors that have spread nearby or to other areas of the body and cannot be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Solid Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative
- What is being tested?
- Cilengitide, Laboratory Biomarker Analysis and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2010to Mar 2015
- Phase
- Phase 1
- 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
- Histologic proof of cancer that is now unresectable (solid tumors, excluding lymphoma)
- For Cohort II only:
- Histologic adenocarcinoma of the breast with manifestations of metastatic cancer or locally advanced, unresectable cancer
- Estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) receptor negative disease per local standards
- Refractory to taxanes which is defined as one of the following:
- Having relapsed during or within 12 months of completing adjuvant paclitaxel or docetaxel
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- Disease progression while on any taxane in the locally advanced, unresectable or metastatic breast cancer setting
- Ability and willingness to undergo biopsy for biomarker testing prior to start of treatment
- Disease must be measurable by imaging-based evaluation per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v1.1)
- Up to 5 prior regimens of chemotherapy for metastatic disease are allowed
- Absolute neutrophil count (ANC) >= 1500/μL
- Hemoglobin (Hgb) >= 9 g/dL
- Platelets (PLT) >= 100,000/μL
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) =< 3 x ULN or AST =< 5 x ULN if liver involvement
- Creatinine =< 1.5 x ULN
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, or 1 (or Karnofsky performance status [KPS] > 70)
- Ability to provide informed consent
- Willingness to return to the enrolling Mayo Clinic institution for follow-up
- Life expectancy >= 12 weeks
- All patients: Willingness to provide blood samples for the mandatory correlative research component
- For Cohort II, tissue biopsies are mandatory
- Women of childbearing potential only: negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential including women within 2 years of post-menopause
Who cannot join
- Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Any of the following prior therapies:
- Chemotherapy =< 21 days prior to registration
- Mitomycin C/nitrosoureas =< 42 days prior to registration
- Immunotherapy =< 14 days prior to registration
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- Biologic therapy =< 14 days prior to registration
- Prior investigational therapy =< 28 days prior to registration
- Full field radiation therapy =< 28 days prior to registration or limited field radiation therapy < 14 days prior to registration
- Full field radiation encompasses the entire area of known disease involvement and surrounding uninvolved but at-risk areas, e.g. subtotal nodal (mantle and upper abdomen) or total nodal irradiation
- Limited field radiation is restricted to treating only the known areas of clinical disease, e.g. involved-field therapy for lymphoma
- Major surgery (i.e., laparotomy) =< 4 weeks prior to registration; minor surgery =< 2 weeks prior to registration; Note: insertion of a vascular access device is not considered major or minor surgery in this regard
- Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to =< grade 1, unless the patient has a chronic, stable =< grade 2 toxicity that would not interfere with the evaluation of the study agents
- New York Heart Association classification III or IV
- Central nervous system (CNS) metastases or seizure disorder; Note: CNS metastases are allowed if previously treated and stable for at least 4 weeks
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, injections, intrauterine device [IUD], or abstinence, etc.); oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive on highly active antiretroviral therapy (HAART) therapy
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Other active malignancy =< 3 years prior to registration; EXCEPTIONS: nonmelanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
- History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Uncontrolled hypertension, labile hypertension of history of poor compliance with antihypertensive medication
- Patients with active, bleeding diathesis
- Non-disease related- major surgery, =< 28 days or minor surgery =< 7 days prior to registration
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: A Phase I, Open Label, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetic Properties of the Combination of Cilengitide and Paclitaxel in Patients With Advanced Solid Malignancies
This phase I trial studies the side effects and the best dose of cilengitide when given together with paclitaxel weekly in treating patients with solid tumors that have spread nearby or to other areas of the body and cannot be removed by surgery. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to the stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cilengitide together with paclitaxel may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximally tolerated dose (MTD) of cilengitide and paclitaxel at weekly dose schedule. (Cohort I) II. To describe the toxicities associated with cilengitide and paclitaxel. III. To describe any antitumor activity of cilengitide and paclitaxel at weekly dose schedule.
IV. To characterize pharmacokinetics (PK) of cilengitide and paclitaxel with the proposed schedule and correlate PK parameters to clinical outcome. (Cohort I) V. To examine the effect of cilengitide and paclitaxel on circulating cysteine-rich, angiogenic inducer, 61 (Cyr61) using a novel "sandwich enzyme-linked immunosorbent assay (ELISA)" and to correlate this effect with clinical response. (Cohort II) VI. To evaluate the information obtained through use of items from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Phase I studies.
VII. To determine if tumor tissue expression of alpha v beta 3 (αvβ3) and CYR61 correlate with therapeutic response to cilengitide with paclitaxel. (Cohort II)
OUTLINE: This is a dose-escalation study of cilengitide.
Patients receive cilengitide intravenously (IV) over 1 hour on days* 1, 8, and 15 and paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Some patients receive cilengitide IV over 1 hour on days 1, 2, 8, 9, 15, and 16.
After completion of study treatment, patients are followed up for 3 months.
- Conditions
- Adult Solid Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative, Male Breast Carcinoma, Progesterone Receptor Negative, Recurrent Breast Carcinoma
- Being tested
- Cilengitide, Laboratory Biomarker Analysis, Paclitaxel, Pharmacological Study
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilengitideDrug
Also called EMD 121974, EMD-121974
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cilengitide, paclitaxel) | Experimental | Patients receive cilengitide IV over 1 hour on days* 1, 8, and 15 and paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Some patients receive cilengitide IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Receives: Drug: Cilengitide; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best response, defined to be complete response (CR) or partial response (PR) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall and by tumor group).
Measured: From start of the treatment until disease progression/recurrence, assessed up to 3 months
Change in Cyr61 expression levels (Cohort II)
At the end of each cycle, the percent change in serum Cyr61 expression from pre-treatment levels will be determined for each patient. For each patient, a times series plot of the percent change in serum Cyr61 expression from pre-treatment levels will be constructed and visually inspected for trends across time as well as for differences between those who respond to treatment (CR or PR by RECIST criteria) and those who do not.
Measured: Baseline to up to 3 months
Change in Cyr61 expression levels (Cohort II)
A Wilcoxon rank sum test will be used to assess the percent change in Cyr61expression level after one cycle of treatment from pretreatment levels differs between those who progress within 120 days (within the first 6 cycles of treatment) and those who remain progression-free at least 120 days.
Measured: Baseline to 21 days
Incidence of grade 3+ adverse events, as graded using NCI CTCAE v 4.0
The number and severity of grade 3+ adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population.
Measured: Up to 3 months
Incidence of hematologic toxicity, including thrombocytopenia, neutropenia, and leukopenia, evaluated via the ordinal CTC
Assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
Measured: Up to 3 months
Incidence of non-hematologic toxicity, evaluated via the ordinal Common Toxicity Criteria (CTC)
Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
Measured: Up to 3 months
MTD of cilengitide and paclitaxel, defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients as graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: 3 weeks
Number of all adverse events, graded according to the NCI CTCAE v4.0
The number of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population.
Measured: Up to 3 months
Overall survival (OS) (Cohort II)
Kaplan-Meier method will be used to estimate the distribution of OS time.
Measured: The time of registration to death due to any cause, assessed up to 3 months
Progression-free survival (PFS) (Cohort II)
Kaplan-Meier method will be used to estimate the distribution of PFS time.
Measured: The time of registration to documentation of disease event where a disease event is local/regional/distant progression, contralateral breast disease, second primary disease or death due to any cause, assessed up to 3 months
Response rate, defined as the proportion of patients whose tumor responds to treatment (Cohort II)
Calculated as the number of eligible patients whose tumor meets the criteria for a CR or PR on two consecutive evaluations at least 6 weeks apart divided by the number of eligible patients with metastatic breast cancer refractory to taxanes who begin treatment. A 95% binomial confidence interval will be constructed for the true response rate.
Measured: Up to 3 months
Severity of all adverse events, graded according to NCI CTCAE v4.0
The severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population.
Measured: Up to 3 months
Time to progression
Measured: Up to 3 months
Time to treatment failure
Measured: Time from registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months
Time until any treatment related toxicity
Measured: Up to 3 months
Time until hematologic nadir for ANC
Measured: Up to 3 months
Time until hematologic nadir for platelets
Measured: Up to 3 months
Time until hematologic nadir for WBC
Measured: Up to 3 months
Time until treatment related grade 3+ toxicity
Measured: Up to 3 months
Secondary outcomes (1)
Incidence of toxicity, as assessed using PRO-CTCAE
The PRO-CTCAE will be summarized descriptively, and the dropout rate will be used for feasibility study. Informal comparison and correlation of the PRO-CTCAE symptoms with their corresponding items in clinician reported CTCAE will be conducted in an exploratory manner. Chi-squared tests will be used without adjustment for multiple comparisons.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Julian Molina, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276496
- Sponsor's protocol ID
- NCI-2013-00619
- Other IDs
- NCI-2013-00619, U01CA069912, MC0915, 8335, P30CA015083
- Status last verified
- Mar 2015
- First submitted
- 12 Jan 2011
- Last updated
- 15 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetic Properties of the Combination of Cilengitide and Paclitaxel in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01276496
- Acronym / sponsor ID
- NCI-2013-00619
- Conditions
- Adult Solid Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative, Male Breast Carcinoma, Progesterone Receptor Negative, Recurrent Breast Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2010
- Primary completion
- Mar 2015 (actual)
- First posted
- 13 Jan 2011 (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.
This phase I trial studies the side effects and the best dose of cilengitide when given together with paclitaxel weekly in treating patients with solid tumors that have spread nearby or to other areas of the body and cannot be removed by surgery. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to the stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cilengitide together with paclitaxel may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximally tolerated dose (MTD) of cilengitide and paclitaxel at weekly dose schedule. (Cohort I) II. To describe the toxicities associated with cilengitide and paclitaxel. III. To describe any antitumor activity of cilengitide and paclitaxel at weekly dose schedule.
IV. To characterize pharmacokinetics (PK) of cilengitide and paclitaxel with the proposed schedule and correlate PK parameters to clinical outcome. (Cohort I) V. To examine the effect of cilengitide and paclitaxel on circulating cysteine-rich, angiogenic inducer, 61 (Cyr61) using a novel "sandwich enzyme-linked immunosorbent assay (ELISA)" and to correlate this effect with clinical response. (Cohort II) VI. To evaluate the information obtained through use of items from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Phase I studies.
VII. To determine if tumor tissue expression of alpha v beta 3 (αvβ3) and CYR61 correlate with therapeutic response to cilengitide with paclitaxel. (Cohort II)
OUTLINE: This is a dose-escalation study of cilengitide.
Patients receive cilengitide intravenously (IV) over 1 hour on days* 1, 8, and 15 and paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Some patients receive cilengitide IV over 1 hour on days 1, 2, 8, 9, 15, and 16.
After completion of study treatment, patients are followed up for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cilengitide, paclitaxel) | Experimental | Drug: Cilengitide, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Pharmacological StudyPatients receive cilengitide IV over 1 hour on days* 1, 8, and 15 and paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: *Some patients receive cilengitide IV over 1 hour on days 1, 2, 8, 9, 15, and 16. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologic proof of cancer that is now unresectable (solid tumors, excluding lymphoma)
- For Cohort II only:
- Absolute neutrophil count (ANC) >= 1500/μL
- Hemoglobin (Hgb) >= 9 g/dL
- Platelets (PLT) >= 100,000/μL
Key exclusion criteria (28 listed)
- Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Any of the following prior therapies:
- Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to =< grade 1, unless the patient has a chronic, stable =< grade 2 toxicity that would not interfere with the evaluation of the study agents
- New York Heart Association classification III or IV
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 |
|---|---|---|
| CilengitideAlso: EMD 121974, EMD-121974Given IV | Drug | Treatment (cilengitide, paclitaxel) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (cilengitide, paclitaxel) |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven IV | Drug | Treatment (cilengitide, paclitaxel) |
| Pharmacological StudyCorrelative studies | Other | Treatment (cilengitide, paclitaxel) |
Primary outcome
Best response, defined to be complete response (CR) or partial response (PR) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: From start of the treatment until disease progression/recurrence, assessed up to 3 months
Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall and by tumor group).
Change in Cyr61 expression levels (Cohort II)
Time frame: Baseline to up to 3 months
At the end of each cycle, the percent change in serum Cyr61 expression from pre-treatment levels will be determined for each patient. For each patient, a times series plot of the percent change in serum Cyr61 expression from pre-treatment levels will be constructed and visually inspected for trends across time as well as for differences between those who respond to treatment (CR or PR by RECIST criteria) and those who do not.
Change in Cyr61 expression levels (Cohort II)
Time frame: Baseline to 21 days
A Wilcoxon rank sum test will be used to assess the percent change in Cyr61expression level after one cycle of treatment from pretreatment levels differs between those who progress within 120 days (within the first 6 cycles of treatment) and those who remain progression-free at least 120 days.
Incidence of grade 3+ adverse events, as graded using NCI CTCAE v 4.0
Time frame: Up to 3 months
The number and severity of grade 3+ adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population.
Incidence of hematologic toxicity, including thrombocytopenia, neutropenia, and leukopenia, evaluated via the ordinal CTC
Time frame: Up to 3 months
Assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
Incidence of non-hematologic toxicity, evaluated via the ordinal Common Toxicity Criteria (CTC)
Time frame: Up to 3 months
Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
MTD of cilengitide and paclitaxel, defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients as graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: 3 weeks
Number of all adverse events, graded according to the NCI CTCAE v4.0
Time frame: Up to 3 months
The number of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population.
Overall survival (OS) (Cohort II)
Time frame: The time of registration to death due to any cause, assessed up to 3 months
Kaplan-Meier method will be used to estimate the distribution of OS time.
Progression-free survival (PFS) (Cohort II)
Time frame: The time of registration to documentation of disease event where a disease event is local/regional/distant progression, contralateral breast disease, second primary disease or death due to any cause, assessed up to 3 months
Kaplan-Meier method will be used to estimate the distribution of PFS time.
Response rate, defined as the proportion of patients whose tumor responds to treatment (Cohort II)
Time frame: Up to 3 months
Calculated as the number of eligible patients whose tumor meets the criteria for a CR or PR on two consecutive evaluations at least 6 weeks apart divided by the number of eligible patients with metastatic breast cancer refractory to taxanes who begin treatment. A 95% binomial confidence interval will be constructed for the true response rate.
Severity of all adverse events, graded according to NCI CTCAE v4.0
Time frame: Up to 3 months
The severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population.
Time to progression
Time frame: Up to 3 months
Time to treatment failure
Time frame: Time from registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months
Time until any treatment related toxicity
Time frame: Up to 3 months
Time until hematologic nadir for ANC
Time frame: Up to 3 months
Time until hematologic nadir for platelets
Time frame: Up to 3 months
Time until hematologic nadir for WBC
Time frame: Up to 3 months
Time until treatment related grade 3+ toxicity
Time frame: Up to 3 months
1 secondary outcome
Incidence of toxicity, as assessed using PRO-CTCAE
Time frame: Up to 3 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 15 Mar 2016.
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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.
Julian Molina principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cilengitide, Laboratory Biomarker Analysis and Paclitaxel in people with Adult Solid Neoplasm and Estrogen Receptor Negative, run by National Cancer Institute (NCI) 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 23 inclusion and 28 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 15 Mar 2016. 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 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.
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?
Best response, defined to be complete response (CR) or partial response (PR) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: From start of the treatment until disease progression/recurrence, assessed up to 3 months). The study lists 19 primary outcomes in all. 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 15 Mar 2016.