Lymphoid Hematological MalignanciesPhase 1CLC-102NCT02223598
A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological Malignancies
A Phase 1 study testing CB-5083 and Dexamethasone in people with Lymphoid Hematological Malignancies and Relapsed and Refractory Multiple Myeloma, run by Cleave Biosciences, Inc. at 8 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety, tolerability, dose limiting toxicities, and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoid Hematological Malignancies, Relapsed and Refractory Multiple Myeloma
- What is being tested?
- CB-5083 and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 25 Aug 2014to 26 Jul 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥18 years of age at the time of signing the consent form.
- Dose Escalation Phase: Have a documented diagnosis of a lymphoid hematological malignancy as described by the 2008 World Health Organization (WHO) classification that requires therapy and for which there is no standard of care or standard of care is not expected to be effective. Subjects must not be candidates for anti-tumor regimens known to provide clinical benefit.
- MM Dose Expansion Cohort:
- Must have a documented diagnosis of relapsed and refractory multiple myeloma defined by the International Myeloma Working Group (IMWG) criteria.
- Must have measurable disease defined as:
- Serum M-protein ≥ 0.5g/dL of IgA or ≥ 1 g/dL of IgG, or
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- Urine M-protein ≥ 200 mg/24 hr, or
- Involved FLC assay > 10 mg/dL with abnormal FLC ratio.
- Must have received at least 4 prior therapies, including an alkylating agent (unless not clinically indicated), proteasome inhibitor, an immunomodulatory (IMiD) and CD38 targeted therapy. At least 3 prior therapies where CD38 targeted therapies are not approved, not commercially accessible, contraindicated or refused by subject.
- DLBCL Dose Expansion Arm:
- Must have histologically confirmed DLBCL that is relapsed or refractory to previous therapy.
- Must have ≥1 measurable disease sites as defined by standard Lugano classification.
- Must have received at least 2 prior therapies, including a CD20 targeted therapy, alkylating agent or corticosteroid; subjects who are not eligible for high-dose chemotherapy and autologous stem cell transplantation (HD-ASCT) are eligible with exposure to at least 1 prior therapy.
- Waldstrom's Macroglobulinemia Dose Expansion Arm:
- Must have a confirmed diagnosis of WM as defined by the Second International Workshop, with a clinical indication for treatment.
- Must have measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of ≥ 2 times the upper limit of each institution's normal value is required.
- Must have relapsed/refractory disease after receiving 1 or more lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor (eg ibrutinib) if approved by the local health authority and commercially accessible.
- All Arms:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Adequate bone marrow function without transfusion or growth factor support, defined as:
- Absolute neutrophil count ≥ 1,000/μL;
- Platelet count ≥ 50,000/μL;
- Hemoglobin ≥ 8.0 g/dL
- Adequate organ function defined as:
- Serum creatinine ≤ 1.5 mg/dL or creatinine clearance > 45 mL/min according to Cockcroft-Gault formula; (If creatinine clearance calculated from a 24-hour urine sample is ≥45 mL/min, the subject will qualify for the study).
- Serum total bilirubin ≤ 2.0 mg/dL (34.2 μmol/L); or > 3.0 × upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinemia
- AST (SGOT) ≤ 3 × the ULN;
- ALT (SGPT) ≤ 3 × the ULN;
- Subjects who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female subjects need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if subject is of childbearing potential. Non-childbearing is defined as ≥ 1 year postmenopausal or surgically sterilized).
- Willing and able to provide written Informed Consent and adhere to study procedures.
Who cannot join
- Subjects with leukemia are excluded, with the exception of chronic lymphocytic leukemia (CLL), who are allowed in the dose escalation phase. Subjects with Burkitt lymphoma, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or amyloidosis are also excluded.
- Clinically active central nervous system (CNS) cancer involvement. Imaging to exclude CNS involvement not required.
- Previous or concomitant malignancy, except for basal-cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix. Subjects with other malignancies are eligible if they have remained disease free for at least 2 years prior to study entry;
- Use of any anti-cancer drug therapy within 14 days prior to Baseline (within 28 days for monoclonal antibodies [eg anti-CD38]).
- Use of any investigational agent within 28 days prior to Baseline.
- Presence of clinically significant non-hematological toxicity of prior chemotherapy that has not resolved to ≤ Grade 1 as determined by CTCAE v 4.0, with the exception of alopecia and peripheral neuropathy. Note: Peripheral neuropathy > Grade 2 plus pain, or Grade 3 or Grade 4 are excluded.
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- Radiotherapy within 14 days prior to Baseline.
- Major surgery within 6 weeks prior to Baseline. The subject must have recovered from surgery and be without current complications of infection or dehiscence.
- Peripheral autologous stem cell transplant within 12 weeks prior to Baseline; prior allogeneic transplants within 16 weeks or chronic use of immunosuppressants.
- Active infection requiring systemic therapy, including known human immunodeficiency virus (HIV), acquired immunodeficiency syndrome-related illness, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Major cardiac abnormalities as defined but not limited to the following: uncontrolled angina or unstable life-threatening arrhythmias, history of myocardial infarction within 12 weeks prior to Baseline, Class 3 or higher New York Heart Association (NYHA) congestive heart failure, or severe cardiac insufficiency, persistent (3 consecutive electrocardiograms (ECGs) performed ≥ 5 minutes apart) prolongation of the QTc (Fridericia) interval to > 480 msec.
- Cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 12 weeks prior to Baseline.
- Major gastrointestinal (GI) disease as defined but not limited to the following: history of inflammatory bowel disease or other illness resulting in chronic diarrhea, known achlorhydria or history of GI surgery that could reduce the acidity of the stomach, acute pancreatitis or cholecystitis within 6 months prior to Baseline, or GI disease that may interfere with the absorption of orally-administered drugs.
- Grade 3 or 4 eye disorder at study entry, unless stable and longstanding (>3 months) and unlikely to interfere with protocol-required ophthalmology assessments.
- A condition that is expected to require concomitant use of any medication listed as prohibited while on study.
- Is a pregnant or lactating female.
- Has any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of the study results and, in the Investigator's opinion, would make the subject inappropriate for entry into this study.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Emory University
Atlanta, Georgia, 30322
RCCA MD
Bethesda, Maryland, 20817
City of Hope National Medical Center
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of California, San Francisco
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63110
Canada2 sites
Cedars Cancer Centre, McGill University Health Centre
Montreal, Quebec, H4A 3J1
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1, Dose-Escalation/Dose-Expansion Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamic Effects of Orally Administered CB-5083 in Subjects With Lymphoid Hematological Malignancies
The purpose of this study is to determine the safety, tolerability, dose limiting toxicities, and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological malignancies.
- Being tested
- CB-5083, Dexamethasone
- Keywords
- Lymphoid Hematological Malignancies
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-5083Drug
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation - CB-5083 | Experimental | CB-5083 will be administered orally, 4 days on and 3 days off, for 28 day cycles, as a single agent to subjects with lymphoid hematological malignancies Receives: Drug: CB-5083 |
| Dose Expansion - CB-5083, Dexamethasone | Experimental | CB-5083 will be administered orally, 4 days on and 3 days off, for 28 day cycles, as a single agent to subjects with relapsed and refractory multiple myeloma; in addition, subjects who develop progressive disease at the end of Cycle 1, or beyond, may receive their current dose of CB-5083 in combination with oral or IV low dose Dexamethasone (40 mg) Receives: Drug: CB-5083; Drug: Dexamethasone |
| Dose Expansion - CB-5083 | Experimental | CB-5083 will be administered orally, daily, 4 days on and 3 days off, for 28 day cycles, as a single agent to subjects with diffuse large B-cell lymphoma (DLBCL) or Waldenstrom Macroglobulinemia, if such arm is opened, per Sponsor Receives: Drug: CB-5083 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the dose limiting toxicities (DLTs) of oral CB-5083 in subjects with lymphoid hematological malignancies
Measured: Dose Escalation Stage - the first 28 days of treatment (Cycle 1) with CB-5083
To determine the pharmacokinetic (PK) profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the AUC
Measured: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 in the second 28 days (Cycle 2) of treatment with CB-5083
To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmax
Measured: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmin
Measured: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Tmax
Measured: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the T1/2
Measured: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed and refractory Multiple Myeloma at the maximum tolerated dose (MTD) at the end of the Dose Escalation Stage
Measured: Dose Expansion Stage - from day 1 of Cycle 1 through 28 days after the patient's last cycle of treatment
To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed/refractory DLBCL or Waldenstrom Macroglobulinemia at the MTD
Measured: Dose Expansion Stage - from day 1 of Cycle 1 through 28 days after the patient's last cycle of treatment
Secondary outcomes (7)
To assess the pharmacodynamic (PD) effects of CB-5083 in peripheral blood cells and cancer cells
Measured: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1
To further asses the PK profile of oral CB-5083 in subjects by measuring the AUC
Measured: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To further asses the PK profile of oral CB-5083 in subjects by measuring the Cmax
Measured: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To further asses the PK profile of oral CB-5083 in subjects by measuring the Cmin
Measured: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To further asses the PK profile of oral CB-5083 in subjects by measuring the Tmax
Measured: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To further asses the PK profile of oral CB-5083 in subjects by measuring the T1/2
Measured: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To evaluate preliminary efficacy of oral CB-5083 in subjects, using standard response criteria
Measured: Dose Expansion Stages - at the end of each 28 day cycle of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study start25 Aug 2014
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Why it stopped: MTD determined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoid Hematological MalignanciesStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleave Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223598
- Sponsor's protocol ID
- CLC-102
- Acronym
- CLC-102
- Status last verified
- Jun 2017
- First submitted
- 15 Aug 2014
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose-Escalation/Dose-Expansion Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamic Effects of Orally Administered CB-5083 in Subjects With Lymphoid Hematological Malignancies
- ClinicalTrials.gov ID
- NCT02223598
- Acronym / sponsor ID
- CLC-102 / CLC-102
- Keywords
- Lymphoid Hematological Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: MTD determined
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cleave Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2014 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 22 Aug 2014 (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 determine the safety, tolerability, dose limiting toxicities, and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation - CB-5083 | Experimental | Drug: CB-5083CB-5083 will be administered orally, 4 days on and 3 days off, for 28 day cycles, as a single agent to subjects with lymphoid hematological malignancies |
| Dose Expansion - CB-5083, Dexamethasone | Experimental | Drug: CB-5083, Drug: DexamethasoneCB-5083 will be administered orally, 4 days on and 3 days off, for 28 day cycles, as a single agent to subjects with relapsed and refractory multiple myeloma; in addition, subjects who develop progressive disease at the end of Cycle 1, or beyond, may receive their current dose of CB-5083 in combination with oral or IV low dose Dexamethasone (40 mg) |
| Dose Expansion - CB-5083 | Experimental | Drug: CB-5083CB-5083 will be administered orally, daily, 4 days on and 3 days off, for 28 day cycles, as a single agent to subjects with diffuse large B-cell lymphoma (DLBCL) or Waldenstrom Macroglobulinemia, if such arm is opened, per Sponsor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Males and females ≥18 years of age at the time of signing the consent form.
- Dose Escalation Phase: Have a documented diagnosis of a lymphoid hematological malignancy as described by the 2008 World Health Organization (WHO) classification that requires therapy and for which there is no standard of care or standard of care is not expected to be effective. Subjects must not be candidates for anti-tumor regimens known to provide clinical benefit.
- Must have a documented diagnosis of relapsed and refractory multiple myeloma defined by the International Myeloma Working Group (IMWG) criteria.
- Must have measurable disease defined as:
- Must have received at least 4 prior therapies, including an alkylating agent (unless not clinically indicated), proteasome inhibitor, an immunomodulatory (IMiD) and CD38 targeted therapy. At least 3 prior therapies where CD38 targeted therapies are not approved, not commercially accessible, contraindicated or refused by subject.
Key exclusion criteria (17 listed)
- Subjects with leukemia are excluded, with the exception of chronic lymphocytic leukemia (CLL), who are allowed in the dose escalation phase. Subjects with Burkitt lymphoma, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or amyloidosis are also excluded.
- Clinically active central nervous system (CNS) cancer involvement. Imaging to exclude CNS involvement not required.
- Previous or concomitant malignancy, except for basal-cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix. Subjects with other malignancies are eligible if they have remained disease free for at least 2 years prior to study entry;
- Use of any anti-cancer drug therapy within 14 days prior to Baseline (within 28 days for monoclonal antibodies [eg anti-CD38]).
- Use of any investigational agent within 28 days prior to Baseline.
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 |
|---|---|---|
| CB-5083 | Drug | Dose Escalation - CB-5083, Dose Expansion - CB-5083, Dose Expansion - CB-5083, Dexamethasone |
| Dexamethasone | Drug | Dose Expansion - CB-5083, Dexamethasone |
Primary outcome
To determine the dose limiting toxicities (DLTs) of oral CB-5083 in subjects with lymphoid hematological malignancies
Time frame: Dose Escalation Stage - the first 28 days of treatment (Cycle 1) with CB-5083
To determine the pharmacokinetic (PK) profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the AUC
Time frame: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 in the second 28 days (Cycle 2) of treatment with CB-5083
To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmax
Time frame: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmin
Time frame: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Tmax
Time frame: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the T1/2
Time frame: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed and refractory Multiple Myeloma at the maximum tolerated dose (MTD) at the end of the Dose Escalation Stage
Time frame: Dose Expansion Stage - from day 1 of Cycle 1 through 28 days after the patient's last cycle of treatment
To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed/refractory DLBCL or Waldenstrom Macroglobulinemia at the MTD
Time frame: Dose Expansion Stage - from day 1 of Cycle 1 through 28 days after the patient's last cycle of treatment
7 secondary outcomes
To assess the pharmacodynamic (PD) effects of CB-5083 in peripheral blood cells and cancer cells
Time frame: Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1
To further asses the PK profile of oral CB-5083 in subjects by measuring the AUC
Time frame: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To further asses the PK profile of oral CB-5083 in subjects by measuring the Cmax
Time frame: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To further asses the PK profile of oral CB-5083 in subjects by measuring the Cmin
Time frame: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To further asses the PK profile of oral CB-5083 in subjects by measuring the Tmax
Time frame: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To further asses the PK profile of oral CB-5083 in subjects by measuring the T1/2
Time frame: Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083
To evaluate preliminary efficacy of oral CB-5083 in subjects, using standard response criteria
Time frame: Dose Expansion Stages - at the end of each 28 day cycle of treatment
Results and safety
The study was stopped early (reason given: MTD determined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CB-5083 and Dexamethasone in people with Lymphoid Hematological Malignancies and Relapsed and Refractory Multiple Myeloma, run by Cleave Biosciences, Inc. at 8 sites in 2 countries.
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 30 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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 was stopped early (reason given: MTD determined). Results are not available in the source record.
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?
To determine the dose limiting toxicities (DLTs) of oral CB-5083 in subjects with lymphoid hematological malignancies (time frame: Dose Escalation Stage - the first 28 days of treatment (Cycle 1) with CB-5083). The study lists 8 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 27 Feb 2018.