Endometrial CancerPhase 1NCT01256268
Carboplatin/Taxol/Ridaforolimus in Endometrial, Ovarian and Solids
A Phase 1 study testing Ridaforolimus, Paclitaxel and carboplatin in people with Endometrial Cancer and Ovarian Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to: Test the safety of a new investigational drug called MK-8669 (ridaforolimus) Determine the maximum tolerated dose of MK-8669 Determine the effectiveness of the maximum tolerated dose of MK-8669 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Ovarian Cancer
- What is being tested?
- Ridaforolimus, Paclitaxel and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2011to 3 Aug 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have measurable disease or evaluable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be a minimum size of 10 mm by CT scan (CT scan slice thickness no greater than 5 mm), 10 mm caliper measurement by clinical exam or 20 mm by chest X-ray. Lymph node must be ≥ 15 mm in short axis when assessed by CT scan. Evaluable disease is disease evident on imaging that does not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1, however, meets tumor marker evaluation, e.g., Gynecologic Cancer Intergroup (GCIG) criteria. Notes: i) If the patient's only disease is confined to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology unless it is accompanied by GCIG criteria or can be clearly be shown as new disease when compared to prior imaging. ii) Disease in a previously irradiated field is acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy.
- Age > 18 years and competent to give informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 and a life expectancy of at least 60 days.
- Patients must have adequate: Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (CTCAE v4.0) grade 1. Platelets greater than or equal to 100,000/ul.; Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1.; Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v4.0 grade 1). serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4.0 grade 1).; Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v4.0 grade 1.; No chemotherapy, radiotherapy, biologic, hormonal, or investigational drug therapy within 28 days prior to start of treatment on study.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to the study entry and be practicing an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an intentional pregnancy.
- Phase 1A - Additional criteria applicable to phase 1A
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- Must have pathologically confirmed solid cancer that is locally advanced or metastatic cancer.
- Patient's physician believes that the cancer is advanced, recurrent or metastatic and not curable by local measures (i.e., surgery, radiation, other drugs).
- Patient's physician believes the patient may potentially benefit from this combination of therapy.
- Patients may have had up to three (3) prior cytotoxic chemotherapeutic regimens including prior treatment with carboplatin and paclitaxel. Chemotherapy drug changes and modifications made for reasons other than progression are not considered a separate regimen. Examples would be drug changes for toxicity or consolidation chemotherapy after adjuvant treatment. Patients may have received any number of prior non-cytotoxic regimens such as monoclonal antibodies, cytokines, signal transduction inhibitors, or hormonal therapy. Previous radiation therapy is allowed.
- Phase 1B - Endometrial: Additional Inclusion Criteria
- Epithelial endometrial cancer. (i.e. carcinosarcoma, leiomyosarcoma, and endometrial stromal sarcoma are excluded).
- May have had up to one prior chemotherapy for endometrial cancer. Prior taxane or platinum therapy is allowed as long as it was received either as adjuvant therapy or if there were a response to prior therapy and at least 6 months have elapsed since platinum treatment. Radiation sensitizing chemotherapy will not count as a prior regimen.
- Must have measurable disease
- Phase 1B - Ovarian: Additional Inclusion Criteria
- Recurrent epithelial ovarian cancer (no stromal or germ cell ovarian cancers)
- Platinum-sensitive defined as a recurrence at least 6 months (180 days) after the last day of primary adjuvant chemotherapy. Patients may have been retreated with a salvage line of chemotherapy but there must be a platinum-free interval of 6 or more months.
- Two (2) or less prior therapies including adjuvant chemotherapy
- Measurable or evaluable disease
Who cannot join
- An upper gastrointestinal or other condition that would impair swallowing or absorption of oral medication
- Any serious illness or medical condition that would not permit the patient to be managed according to the protocol, including, but not limited to, any the following:
- History of significant neurologic or psychiatric disorder (e.g., uncontrolled psychiatric disorders) that would impair the ability to obtain consent or limit compliance with study requirement
- Active uncontrolled or serious infection
- Active peptic ulcer disease
- Patients who have the following cardiac conditions: Uncontrolled angina or myocardial infarction with the past six months; Diagnosed or suspected congenital long QT syndrome; Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes); Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) on both the Fridericia and Bazett's correction
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- Uncontrolled hypertension defined as systolic greater than 180 and diastolic greater than 100.
- History of other invasive malignancies in the last 3 years, with the exception of non-melanoma skin cancer, unless they have had no evidence of recurrence from that cancer for last two years.
- Serum creatinine >1.5 times the institutional upper limits of normal
- Patients taking certain concomitant medications (see below). Patients can enroll on protocol if they stop these medications and a wash-out period of ≥14 days, unless otherwise noted, is done prior to starting ridaforolimus.
- There must be at least 14 days since prior (and no current expectations to receive) CYP3A4 inhibitors including, but not limited to, any of the following: Azole antifungals ( i.e., ketoconazole, itraconazole, miconazole, fluconazole); HIV protease inhibitors (i.e., indinavir, saquinavir, ritonavir, atazanavir, nelfinavir); Clarithromycin; Verapamil; Erythromycin; Delavirdine; Diltiazem; Nefazodone; Telithromycin
- There must be at least 14 days since prior (and no current expectations to receive) CYP3A4 inducers including, but not limited to, any of the following
- Rifampin
- Phenytoin
- Rifabutin
- St.John's wort
- Carbamazepine
- Efavirenz
- Phenobarbital
- Tipranavir
- Full dose anticoagulation with warfarin (coumadin) or other vitamin K dependent anticoagulant. Low-dose prophylactic warfarin (i.e. 1mg per day port prophylaxis) is allowable. Low molecular heparin (e.g., danaparoid, dalteparin, tinzaparin, enoxaparin) is allowable if patient has been established on therapy.
- Have received an estimated dose of radiation therapy to >35% of the bone marrow.
- Patients previously exposed to mTOR inhibitors are permitted in phase 1A but not allowed in phase 1B.
- History of grade 3 hypersensitivity to paclitaxel. However, if after prior hypersensitivity the patient was subsequently successfully rechallenged without incident, the patient may be eligible at investigator's discretion.
- Known hypersensitivity to the study drug ridaforolimus or its components. Ridaforolimus should be administered with caution to patients known to be hypersensitive to macrolide antibiotics, Tween80 (polysorbate 80), or any other excipient in the product formulation.
- Significant lipid abnormalities: Serum cholesterol > 350mg/dL; Triglycerides > 400mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase 1A/B Study of Combination Carboplatin, Paclitaxel and Ridaforolimus in Patients With Solid, Endometrial, and Ovarian Cancers
The purpose of this study is to:
- Test the safety of a new investigational drug called MK-8669 (ridaforolimus)
- Determine the maximum tolerated dose of MK-8669
- Determine the effectiveness of the maximum tolerated dose of MK-8669
Read the detailed description
This is a phase 1A/1B study. Phase 1A is designed to determine the maximal tolerated dose (MTD) and toxicity of ridaforolimus in combination with paclitaxel and carboplatin in patients with advanced or recurrent solid tumors. The MTD determined in this study will be the recommended dose to study in the phase 1B or in future phase 2 trials.
- Conditions
- Endometrial Cancer, Ovarian Cancer
- Being tested
- Ridaforolimus, Paclitaxel, carboplatin
- Keywords
- metastatic, recurrent, Solid Cancer
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RidaforolimusDrug
Also called AP23573, MK-8669
Phase 1A: Ridaforolimus 20-40 mg will be administered daily for 5 days per week (days 2-5, days 8-12, days 15-19) in the first cycle of therapy and for further cycles on days 1-5, days 8-12, days 15-19 throughout the remainder of therapy. On the day of coadministration of ridaforolimus with paclitaxel 175mg/m^2 IV and carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle, ridaforolimus will be dosed at the time of initiation of paclitaxel infusion. Phase 1B: as outlined in Treatment Arms.
PaclitaxelDrug
Also called Taxol®, NSC #673089
Phase 1A: Paclitaxel 175mg/m2 IV. Phase 1B: As outlined in Treatment Arms.
carboplatinDrug
Also called Paraplatin, NSC #241240
Phase 1A: Carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle. Phase 1B: As outlined in Treatment Arms.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial Cancer | Experimental | Phase 1A + Cohort 1B - Recurrent or Metastatic Endometrial Cancer. Patients with recurrent or metastatic endometrial cancer with up to 1 prior chemotherapy. Ridaforolimus at the Phase 1A MTD and schedule will be administered with paclitaxel at the Phase 1A MTD (175 mg/m2) IV and carboplatin at the phase 1 MTD (AUC 5 to 6) in mg/ml/min on day 1 of each 3 week cycle, ridaforolimus will be dosed at the time of initiation of paclitaxel infusion. Treatment will continue until disease progression or adverse events prohibit further therapy. Receives: Drug: Ridaforolimus; Drug: Paclitaxel; Drug: carboplatin |
| Ovarian Cancer | Experimental | Phase 1 A + Cohort 1B - Recurrent or Metastatic Ovarian Cancer. Patients with platinum-sensitive, recurrent ovarian cancer with up to 2 prior chemotherapy regimens. Ridaforolimus at the phase 1A MTD and schedule will be administered with paclitaxel at the phase 1 MTD (175 mg/m2) IV and carboplatin at the phase 1 MTD (AUC 5 to 6) in mg/ml/min on day 1 of each 3 week cycle, ridaforolimus will be dosed at the time of initiation of paclitaxel infusion. Treatment will continue until disease progression or adverse events prohibit further therapy. Receives: Drug: Ridaforolimus; Drug: Paclitaxel; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1A - Maximum Tolerated Dose (MTD)
To determine the maximal tolerated dose of oral ridaforolimus in combination with paclitaxel and carboplatin during the first cycle of treatment.
Measured: Average of six months
Part 1B - Number of Participants With Response to Treatment as a Measure of Preliminary Efficacy
To determine the preliminary efficacy [defined as the response rate (complete and partial response rate), stable disease (neither progression or response after the completion of at least 2 cycles), and duration of response] of the 1A maximal tolerated dose (MTD) of oral ridaforolimus in combination with paclitaxel and carboplatin in two separate expansion cohorts.
Measured: Average of six months
Secondary outcomes (2)
Part 1A - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To describe the toxicities of this combination of therapy.
Measured: Average of six months
Part 1B - Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
The final safety analysis will include all patients who receive at least one dose of the treatment. The incidence of SAEs that are treatment related will be summarized by type and severity and the exact 95% confidence intervals for the rates of such SAEs will be computed based on the exact binomial distribution.
Measured: Average of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study start13 Jun 2011
- Primary completion3 Feb 2016
- Study completion3 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Robert Wenham, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256268
- Sponsor's protocol ID
- MCC-16472
- Status last verified
- Aug 2017
- First submitted
- 1 Dec 2010
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chon HS, Kang S, Lee JK, Apte SM, Shahzad MM, Williams-Elson I, Wenham RM. Phase I study of oral ridaforolimus in combination with paclitaxel and carboplatin in patients with solid tumor cancers. BMC Cancer. 2017 Jun 8;17(1):407. doi: 10.1186/s12885-017-3394-2.
PubMed 28595616
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1A/B Study of Combination Carboplatin, Paclitaxel and Ridaforolimus in Patients With Solid, Endometrial, and Ovarian Cancers
- ClinicalTrials.gov ID
- NCT01256268
- Acronym / sponsor ID
- MCC-16472
- Conditions
- Endometrial Cancer, Ovarian Cancer
- Keywords
- metastatic, recurrent, Solid Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 13 Jun 2011 (actual)
- Primary completion
- 3 Feb 2016 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 8 Dec 2010 (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 purpose of this study is to:
- Test the safety of a new investigational drug called MK-8669 (ridaforolimus)
- Determine the maximum tolerated dose of MK-8669
- Determine the effectiveness of the maximum tolerated dose of MK-8669
Detailed description
This is a phase 1A/1B study. Phase 1A is designed to determine the maximal tolerated dose (MTD) and toxicity of ridaforolimus in combination with paclitaxel and carboplatin in patients with advanced or recurrent solid tumors. The MTD determined in this study will be the recommended dose to study in the phase 1B or in future phase 2 trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial Cancer | Experimental | Drug: Ridaforolimus, Drug: Paclitaxel, Drug: carboplatinPhase 1A + Cohort 1B - Recurrent or Metastatic Endometrial Cancer. Patients with recurrent or metastatic endometrial cancer with up to 1 prior chemotherapy. Ridaforolimus at the Phase 1A MTD and schedule will be administered with paclitaxel at the Phase 1A MTD (175 mg/m2) IV and carboplatin at the phase 1 MTD (AUC 5 to 6) in mg/ml/min on day 1 of each 3 week cycle, ridaforolimus will be dosed at the time of initiation of paclitaxel infusion. Treatment will continue until disease progression or adverse events prohibit further therapy. |
| Ovarian Cancer | Experimental | Drug: Ridaforolimus, Drug: Paclitaxel, Drug: carboplatinPhase 1 A + Cohort 1B - Recurrent or Metastatic Ovarian Cancer. Patients with platinum-sensitive, recurrent ovarian cancer with up to 2 prior chemotherapy regimens. Ridaforolimus at the phase 1A MTD and schedule will be administered with paclitaxel at the phase 1 MTD (175 mg/m2) IV and carboplatin at the phase 1 MTD (AUC 5 to 6) in mg/ml/min on day 1 of each 3 week cycle, ridaforolimus will be dosed at the time of initiation of paclitaxel infusion. Treatment will continue until disease progression or adverse events prohibit further therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Must have measurable disease or evaluable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be a minimum size of 10 mm by CT scan (CT scan slice thickness no greater than 5 mm), 10 mm caliper measurement by clinical exam or 20 mm by chest X-ray. Lymph node must be ≥ 15 mm in short axis when assessed by CT scan. Evaluable disease is disease evident on imaging that does not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1, however, meets tumor marker evaluation, e.g., Gynecologic Cancer Intergroup (GCIG) criteria. Notes: i) If the patient's only disease is confined to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology unless it is accompanied by GCIG criteria or can be clearly be shown as new disease when compared to prior imaging. ii) Disease in a previously irradiated field is acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy.
- Age > 18 years and competent to give informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 and a life expectancy of at least 60 days.
- Patients must have adequate: Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (CTCAE v4.0) grade 1. Platelets greater than or equal to 100,000/ul.; Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1.; Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v4.0 grade 1). serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4.0 grade 1).; Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v4.0 grade 1.; No chemotherapy, radiotherapy, biologic, hormonal, or investigational drug therapy within 28 days prior to start of treatment on study.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to the study entry and be practicing an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an intentional pregnancy.
Key exclusion criteria (26 listed)
- An upper gastrointestinal or other condition that would impair swallowing or absorption of oral medication
- Any serious illness or medical condition that would not permit the patient to be managed according to the protocol, including, but not limited to, any the following:
- Uncontrolled hypertension defined as systolic greater than 180 and diastolic greater than 100.
- History of other invasive malignancies in the last 3 years, with the exception of non-melanoma skin cancer, unless they have had no evidence of recurrence from that cancer for last two years.
- Serum creatinine >1.5 times the institutional upper limits of normal
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 |
|---|---|---|
| RidaforolimusAlso: AP23573, MK-8669Phase 1A: Ridaforolimus 20-40 mg will be administered daily for 5 days per week (days 2-5, days 8-12, days 15-19) in the first cycle of therapy and for further cycles on days 1-5, days 8-12, days 15-19 throughout the remainder of therapy. On the day of coadministration of ridaforolimus with paclitaxel 175mg/m^2 IV and carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle, ridaforolimus will be dosed at the time of initiation of paclitaxel infusion. Phase 1B: as outlined in Treatment Arms. | Drug | Endometrial Cancer, Ovarian Cancer |
| PaclitaxelAlso: Taxol®, NSC #673089Phase 1A: Paclitaxel 175mg/m2 IV. Phase 1B: As outlined in Treatment Arms. | Drug | Endometrial Cancer, Ovarian Cancer |
| carboplatinAlso: Paraplatin, NSC #241240Phase 1A: Carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle. Phase 1B: As outlined in Treatment Arms. | Drug | Endometrial Cancer, Ovarian Cancer |
Primary outcome
Part 1A - Maximum Tolerated Dose (MTD)
Time frame: Average of six months
To determine the maximal tolerated dose of oral ridaforolimus in combination with paclitaxel and carboplatin during the first cycle of treatment.
Part 1B - Number of Participants With Response to Treatment as a Measure of Preliminary Efficacy
Time frame: Average of six months
To determine the preliminary efficacy [defined as the response rate (complete and partial response rate), stable disease (neither progression or response after the completion of at least 2 cycles), and duration of response] of the 1A maximal tolerated dose (MTD) of oral ridaforolimus in combination with paclitaxel and carboplatin in two separate expansion cohorts.
2 secondary outcomes
Part 1A - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Average of six months
Part 1B - Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Time frame: Average of six 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 30 Aug 2017.
- Derived from this study: PubMed 28595616Chon HS, Kang S, Lee JK, Apte SM, Shahzad MM, Williams-Elson I, Wenham RM. Phase I study of oral ridaforolimus in combination with paclitaxel and carboplatin in patients with solid tumor cancers. BMC Cancer. 2017 Jun 8;17(1):407. doi: 10.1186/s12885-017-3394-2.
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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.
Robert Wenham, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ridaforolimus, Paclitaxel and carboplatin in people with Endometrial Cancer and Ovarian Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site 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 19 inclusion and 26 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Part 1A - Maximum Tolerated Dose (MTD) (time frame: Average of six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256268, which also lists 1 linked publication.
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 30 Aug 2017.