Malignant Solid TumorPhase 1NCT01670175
Sirolimus With Cyclophosphamide and Topotecan for Pediatric/Adolescent Relapsed and Refractory Solid Tumors
A Phase 1 study testing Sirolimus, Cyclophosphamide, Topotecan in people with Malignant Solid Tumor and Childhood Solid Tumor, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a Phase I study of the combination of three drugs: sirolimus, cyclophosphamide, and topotecan. This is the first study to evaluate the safety and clinical activity of the combination of oral sirolimus, oral cyclophosphamide and oral topotecan in pediatric and young adult patients with relapsed and refractory… Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Malignant Solid Tumor, Childhood Solid Tumor
- What is being tested?
- Sirolimus, Cyclophosphamide, Topotecan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Sep 2016
- 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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: Patients must be > than 12 months and 30 years of age at the time of study enrollment.
- Diagnosis: Patients must have had histologic verification of solid tumor, including lymphomas, at original diagnosis or relapse except in patients with intrinsic brain stem tumors, patients with optic pathway gliomas, and patients with pineal tumors and elevations of serum or CSF alpha-fetoprotein or beta-HCG.
- Disease Status: Patients must have either measurable or evaluable disease
- Therapeutic Options: Patient's current disease state must be one for which there is no known curative therapy.
- Performance Level: Karnofsky 50% for patients > 16 years of age and Lansky 50 for patients 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. (Appendix I)
- Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior anticancer chemotherapy.
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- Myelosuppressive chemotherapy: Patients must not have received myelosuppressive therapy within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).
- Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
- Biologic (anti-neoplastic agent): At least 7 days must have passed after the last treatment with a biologic agent. For agents that have known adverse events occurring beyond 7 days from administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
- Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines.
- Monoclonal antibodies: At least 7 days or 3 half-lives, whichever is longer, must have elapsed since prior treatment with a monoclonal antibody. Please see Appendix III for a list of half-lives for common monoclonal antibodies.
- XRT: ≥ 2 weeks must have elapsed for local palliative XRT (small port) and enrollment on study. At least 24 weeks must have elapsed since prior Total Body Irradiation (TBI), radiation to ≥50% of pelvis, or craniospinal radiation; ≥ 6 weeks must have elapsed if the patient has received other substantial BM radiation; > 6 weeks for prior MIBG therapy; For patients with only one site of measurable or evaluable disease, radiation must not have been given to that site unless that site has demonstrated clear progression after radiation or at least 2 months have elapsed since radiation and their remains evidence of viable tumor on biopsy, FDG pet scan or MIBG scan.
- Stem Cell Transplant (SCT): Patients are eligible 12 weeks after myeloablative therapy with autologous stem cell transplant (timed from start of protocol therapy). Patients must meet adequate bone marrow function definition (see organ function requirements below) post-myeloablative therapy. Patients who received stem cell reinfusion following non-myeloablative therapy are eligible once they meet peripheral blood count criteria in 6.1.7.1 Patients status post-allogeneic stem cell transplant are excluded unless they are >1 year post transplant, have been off all immunosuppressive therapy for more than 3 months and do not have active GVHD.
- Prior treatment with sirolimus, cyclophosphamide or topotecan: Patients previously treated with any of these drugs as single agents will be eligible for this study. Patients previously treated with two of the three drugs will also be eligible, however patients previously treated with all three agents in combination will not be eligible.
- Patients previously treated with sirolimus analogues (e.g. Temsirolimus, everolimus, or ridaforolimus) are also eligible.
- Organ Function Requirements
- Adequate Bone Marrow Function Defined as:
- For patients with solid tumors without bone marrow involvement:
- Peripheral absolute neutrophil count (ANC) 750/L
- Platelet count 75,000/L (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
- Patients with known bone marrow metastatic disease:
- Peripheral absolute neutrophil count (AND) ≥ 750/L
- Platelet count ≥ 25,000/L Transfusions are permitted to reach the platelet criteria. These patients will not be evaluable for hematologic toxicity and must not be known to be refractory to platelet transfusions. At least two thirds (2 of 3 or 4 of 6) of every cohort must be evaluable for hematologic toxicity.
- Adequate Liver Function Defined as:
- Bilirubin (sum of conjugated + unconjugated) 1.5 x upper limit of normal (ULN) for age
- SGPT (ALT) 110 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
- Serum albumin 2 g/dL
- Adequate Pulmonary Function Defined as:
- No dyspnea at rest
- No known requirement for supplemental oxygen
- No known active pneumonitis
- Central Nervous System Function Defined as:
- Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and if seizures are well controlled. (See Appendix IV for a list of recommended non-enzyme inducing anticonvulsants).
- Nervous system disorders(CTCAE v4) resulting from prior therapy must be ≤ Grade 2.
- Serum fasting triglyceride level ≤ 300 mg/dL (≤ 3.42 mmol/L) and serum cholesterol level ≤ 300 mg/dL (≤7.75 mmol/L)
Who cannot join
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Concomitant Medications:
- Corticosteroids: Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 days.
- Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible.
- Enzyme-inducing anticonvulsants: Patients who are currently receiving enzyme inducing anticonvulsants are not eligible.
- CYP3A4 active agents: Patients must not be receiving any of the following potent CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's Wort. A list of other known CYP3A4 inducers and inhibitors that should be avoided during study therapy is included in Appendix V.
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- Infection: Patients who have an active or uncontrolled infection are not eligible. Patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
- Patients with history of allergic reactions attributed to compounds of similar composition to sirolimus, cyclophosphamide, or topotecan are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital
San Francisco, California, 94143
About this study
Official title: A Phase I Study of Sirolimus in Combination With Oral Cyclophosphamide and Oral Topotecan in Children and Young Adults With Relapsed and Refractory Solid Tumors
This is a Phase I study of the combination of three drugs: sirolimus, cyclophosphamide, and topotecan. This is the first study to evaluate the safety and clinical activity of the combination of oral sirolimus, oral cyclophosphamide and oral topotecan in pediatric and young adult patients with relapsed and refractory solid tumors.
In this phase I study, the mTOR inhibitor sirolimus will be administered in combination with oral cyclophosphamide and oral topotecan to children with relapsed or refractory solid tumors. The primary aim of this study is to recommend a phase II dose schedule and describe the toxicity of this combination. Myelosuppression will be a targeted toxicity.
Read the detailed description
The combination of cyclophosphamide and topotecan is well-tolerated and provides an oral therapy option for heavily pre-treated patients. The toxicity profile and activity level suggest that this combination will provide a useful platform onto which novel compounds may be added. Sirolimus has been shown to demonstrate single-agent activity in preclinical models of rhabdomyosarcoma, Ewing sarcoma, medulloblastoma, glioblastoma, neuroblastoma, and osteosarcoma. Sirolimus has also been shown to have additive effects in pre-clinical models of solid tumors when combined with cyclophosphamide. This trial therefore will evaluate the combination of sirolimus with cyclophosphamide and topotecan. Pharmacokinetic studies of sirolimus as well as pharmacodynamic studies to assess antiangiogensis and inhibition of the mTOR pathway will be done.
Patients will be accrued to dose levels in cohorts of 3 using a 3 + 3 design. Patients will initially be enrolled on dose level 1. Patients will receive daily oral sirolimus and cyclophosphamide on days 1 - 21 in a 28 day cycle. This will be combined with oral topotecan given on days 1 - 14. Sirolimus will be dosed based on steady-state plasma trough concentrations with a goal level in dose level 1 of 3-7.9 ng/ML and goal levels in subsequent dose levels of 8-12.0 ng/ML. Dosing of cyclophosphamide and topotecan will be 25 mg/m2/dose and 0.8 mg/ m2 /dose respectively for dose levels 1 and 2. Level 3 dosing will escalate cyclophosphamide to 50 mg/ m2/dose. If level 1 dosing is not tolerated, patients will then be enrolled in a level -1 cohort with cyclophosphamide and sirolimus administered only on days 1 - 14. If level -1 is not tolerated, patients will be enrolled in level -2 with topotecan administration limited to days 1 - 7.
- Conditions
- Malignant Solid Tumor, Childhood Solid Tumor
- Being tested
- Sirolimus, Cyclophosphamide, Topotecan
- Keywords
- Histologic verification of solid tumor, including lymphomas, Original diagnosis or relapse
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus, Cyclophosphamide, TopotecanDrug
Dosing of cyclophosphamide and topotecan will be 25 mg/m2/dose and 0.8 mg/ m2 /dose respectively for dose levels 1 and 2. Level 3 dosing will escalate cyclophosphamide to 50 mg/ m2/dose. If level 1 dosing not tolerated, patients will be enrolled in level -1 cohort with cyclophosphamide and sirolimus administered only on days 1-14. If level -1 not tolerated, patients will be enrolled in level -2 with topotecan administration limited to days 1-7.
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus, Cyclophosphamide, Topotecan | Experimental | Sirolimus, Cyclophosphamide, Topotecan Patients accrued to dose levels in cohorts of 3 (3+3 design). Patients will receive daily oral sirolimus and cyclophosphamide days 1-21 in 28-day cycle, combined with oral topotecan given on days 1-14. Sirolimus will be dosed based on steady-state plasma trough concentrations. Receives: Drug: Sirolimus, Cyclophosphamide, Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Define the dose limiting toxicities to recommend a Phase 2 trough concentration of sirolimus when administered on a protracted schedule in combination with oral topotecan and oral cyclophosphamide.
Evaluations done during first Cycle to assess/define DLT:
Physical exams, vitals, blood tests: CBC, CMB, coagulation-PT, LDH, D-dimer, peripheral smear, urine glucose, performance evaluations.
All toxicities observed will be summarized in terms of type (organ affected or laboratory determination), severity (by NCI CTCAE v 4.0), and attribution. The MTD is the highest dose level tested at which 0/6 or 1/6 patients experience DLT that is possibly, probably, or definitely related to the study drug(s) with at least 2/3 or 2/6 patients encountering DLT at the next higher dose. If 0/6 or 1/6 patients experience DLT at the highest dose level (dose level 3), then that dose level will be called the MTD.
Measured: During the first 28-day Cycle
Secondary outcomes (3)
Antitumor Activity
Disease evaluation will take place after completion of the first cycle (CT, MRI, PET and/or MIBG). If the patient has a Partial Response (PR), Complete Response (CR) or Stable Disease (SD) the patient may continue on study.
Measured: At the end of the first 28-day Cycle
Biologic efects of drug combination
Collect preliminary data on the biologic effects of sirolimus on proteins involved in the mTOR signaling pathway.
Pharmacokinetic and pharmacodynamic studies (blood tests) of sirolimus to assess inhibition of the mTOR pathway will be done twice during the first 28-day Cycle.
Measured: During the first 28-day Cycle
Antiangiogenic properties of drug combination
Collect preliminary data regarding the antiangiogenic properties of the combination of sirolimus, topotecan and cyclophosphamide when administered on this schedule.
Pharmacokinetic and pharmacodynamic studies (blood tests) of sirolimus to assess antiangiogensis will be done twice during the first 28-day Cycle.
Measured: During the first 28-day Cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Hyundai Hope On Wheels
- Responsible party
- Sponsor
- Investigators
- Steven Dubois, MD, Study chair, Dana-Farber Cancer InstituteKatherine Matthay, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670175
- Sponsor's protocol ID
- UCSF CC# 12083
- Other IDs
- IRB # 12-09399
- Status last verified
- Jun 2017
- First submitted
- 17 Aug 2012
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Sirolimus in Combination With Oral Cyclophosphamide and Oral Topotecan in Children and Young Adults With Relapsed and Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01670175
- Acronym / sponsor ID
- UCSF CC# 12083
- Conditions
- Malignant Solid Tumor, Childhood Solid Tumor
- Keywords
- Histologic verification of solid tumor, including lymphomas, Original diagnosis or relapse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Hyundai Hope On Wheels
- Study start
- Aug 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Aug 2012 (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 is a Phase I study of the combination of three drugs: sirolimus, cyclophosphamide, and topotecan. This is the first study to evaluate the safety and clinical activity of the combination of oral sirolimus, oral cyclophosphamide and oral topotecan in pediatric and young adult patients with relapsed and refractory solid tumors.
In this phase I study, the mTOR inhibitor sirolimus will be administered in combination with oral cyclophosphamide and oral topotecan to children with relapsed or refractory solid tumors. The primary aim of this study is to recommend a phase II dose schedule and describe the toxicity of this combination. Myelosuppression will be a targeted toxicity.
Detailed description
The combination of cyclophosphamide and topotecan is well-tolerated and provides an oral therapy option for heavily pre-treated patients. The toxicity profile and activity level suggest that this combination will provide a useful platform onto which novel compounds may be added. Sirolimus has been shown to demonstrate single-agent activity in preclinical models of rhabdomyosarcoma, Ewing sarcoma, medulloblastoma, glioblastoma, neuroblastoma, and osteosarcoma. Sirolimus has also been shown to have additive effects in pre-clinical models of solid tumors when combined with cyclophosphamide. This trial therefore will evaluate the combination of sirolimus with cyclophosphamide and topotecan. Pharmacokinetic studies of sirolimus as well as pharmacodynamic studies to assess antiangiogensis and inhibition of the mTOR pathway will be done.
Patients will be accrued to dose levels in cohorts of 3 using a 3 + 3 design. Patients will initially be enrolled on dose level 1. Patients will receive daily oral sirolimus and cyclophosphamide on days 1 - 21 in a 28 day cycle. This will be combined with oral topotecan given on days 1 - 14. Sirolimus will be dosed based on steady-state plasma trough concentrations with a goal level in dose level 1 of 3-7.9 ng/ML and goal levels in subsequent dose levels of 8-12.0 ng/ML. Dosing of cyclophosphamide and topotecan will be 25 mg/m2/dose and 0.8 mg/ m2 /dose respectively for dose levels 1 and 2. Level 3 dosing will escalate cyclophosphamide to 50 mg/ m2/dose. If level 1 dosing is not tolerated, patients will then be enrolled in a level -1 cohort with cyclophosphamide and sirolimus administered only on days 1 - 14. If level -1 is not tolerated, patients will be enrolled in level -2 with topotecan administration limited to days 1 - 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sirolimus, Cyclophosphamide, Topotecan | Experimental | Drug: Sirolimus, Cyclophosphamide, TopotecanSirolimus, Cyclophosphamide, Topotecan Patients accrued to dose levels in cohorts of 3 (3+3 design). Patients will receive daily oral sirolimus and cyclophosphamide days 1-21 in 28-day cycle, combined with oral topotecan given on days 1-14. Sirolimus will be dosed based on steady-state plasma trough concentrations. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (35 listed)
- Age: Patients must be > than 12 months and 30 years of age at the time of study enrollment.
- Diagnosis: Patients must have had histologic verification of solid tumor, including lymphomas, at original diagnosis or relapse except in patients with intrinsic brain stem tumors, patients with optic pathway gliomas, and patients with pineal tumors and elevations of serum or CSF alpha-fetoprotein or beta-HCG.
- Disease Status: Patients must have either measurable or evaluable disease
- Therapeutic Options: Patient's current disease state must be one for which there is no known curative therapy.
- Performance Level: Karnofsky 50% for patients > 16 years of age and Lansky 50 for patients 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. (Appendix I)
Key exclusion criteria (9 listed)
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Concomitant Medications:
- Infection: Patients who have an active or uncontrolled infection are not eligible. Patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
- Patients with history of allergic reactions attributed to compounds of similar composition to sirolimus, cyclophosphamide, or topotecan are not eligible.
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 |
|---|---|---|
| Sirolimus, Cyclophosphamide, TopotecanDosing of cyclophosphamide and topotecan will be 25 mg/m2/dose and 0.8 mg/ m2 /dose respectively for dose levels 1 and 2. Level 3 dosing will escalate cyclophosphamide to 50 mg/ m2/dose. If level 1 dosing not tolerated, patients will be enrolled in level -1 cohort with cyclophosphamide and sirolimus administered only on days 1-14. If level -1 not tolerated, patients will be enrolled in level -2 with topotecan administration limited to days 1-7. | Drug | Sirolimus, Cyclophosphamide, Topotecan |
Primary outcome
Dose Limiting Toxicity
Time frame: During the first 28-day Cycle
Define the dose limiting toxicities to recommend a Phase 2 trough concentration of sirolimus when administered on a protracted schedule in combination with oral topotecan and oral cyclophosphamide. Evaluations done during first Cycle to assess/define DLT: Physical exams, vitals, blood tests: CBC, CMB, coagulation-PT, LDH, D-dimer, peripheral smear, urine glucose, performance evaluations. All toxicities observed will be summarized in terms of type (organ affected or laboratory determination), severity (by NCI CTCAE v 4.0), and attribution. The MTD is the highest dose level tested at which 0/6 or 1/6 patients experience DLT that is possibly, probably, or definitely related to the study drug(s) with at least 2/3 or 2/6 patients encountering DLT at the next higher dose. If 0/6 or 1/6 patients experience DLT at the highest dose level (dose level 3), then that dose level will be called the MTD.
3 secondary outcomes
Antitumor Activity
Time frame: At the end of the first 28-day Cycle
Biologic efects of drug combination
Time frame: During the first 28-day Cycle
Antiangiogenic properties of drug combination
Time frame: During the first 28-day Cycle
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 21 Jun 2017.
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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.
Steven Dubois, MD study chair
Dana-Farber Cancer Institute
Katherine Matthay, MD principal investigator
University of California, San Francisco
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 Sirolimus, Cyclophosphamide, Topotecan in people with Malignant Solid Tumor and Childhood Solid Tumor, run by University of California, San Francisco 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 35 inclusion and 9 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 21 Jun 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?
Dose Limiting Toxicity (time frame: During the first 28-day Cycle). 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 21 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.