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Solid TumorsPhase 1NCT02648711

Alternative Dosing for CRLX101(NLG207) Alone, With Avastin and With mFOLFOX6 in Advanced Solid Tumors

A Phase 1 study testing CRLX101, Bevacizumab and mFOLFOX6 in people with Solid Tumors, run by NewLink Genetics Corporation at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of weekly dosing of CRLX101 (both as monotherapy; (Schedule 1) and in combination with bevacizumab every 2 weeks (Schedule 2) and weekly with a 3 week on / 1 week off schedule in combination with mFOLFOX6… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
CRLX101, Bevacizumab and mFOLFOX6
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
3 sitesUnited States
Study dates
Oct 2015to 7 May 2018
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

  • Male or female adult subjects ≥18 years of age
  • Diagnosis of histologically or cytologically confirmed for:
  • For Schedule 1 and 2: advanced solid tumor malignancy that is refractory to standard therapy and/or for whom no further standard therapy is available
  • For Schedule 3: advanced/metastatic tumors for which mFOLFOX6 is appropriate, or advanced/metastatic tumors that may be sensitive to each component of mFOLFOX6 or sensitive to topoisomerase 1 inhibitors including pancreatic, colorectal, esophageal, gastric, bladder or ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC), cholangiocarcinoma, among others
  • For Schedules 1 and 2: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2, For Schedule 3: ECOG Performance Status of 0 or 1
  • Life expectancy >12 weeks in the opinion of the Investigator
Show all 23Show fewer
  • Subjects with acceptable pre-study* hematology and biochemistry labs ≤3 days prior to Week 1 Day 1 (W1D1) defined as:
  • absolute neutrophil count (ANC) ≥1.500 cells / µL (1.5 x 10°/L, without growth factor support
  • platelet count ≥100,000 cells/µL (100 x 10° cells/L), without growth factor support
  • hemoglobin ≥9 g/dL (90/g/L)
  • serum total bilirubin ≤1.5 upper limit of normal (ULN), unless Gilbert's disease
  • alanine transaminase (ALT) or aspartate transaminase (AST) ≤2.5 x ULN, (5 x ULN for subjects with liver metastases)
  • calculated or measured creatinine clearance ≥40 mL/min
  • NOTE: If screening hematology and biochemistry labs are performed ≤3 days prior to W1D1, additional pre-study labs do not need to be repeated to confirm eligibility. However, if screening hematology and biochemistry labs are performed greater than 3 days prior to W1D1, additional pre-study labs will need to be performed to confirm continued eligibility to ensure labs remain acceptable per protocol
  • Females of childbearing potential must agree to use two effective methods of contraception (or abstain completely from heterosexual intercourse) from the time of informed consent and for 30 days following last dose of study drug
  • NOTE: Females of childbearing potential are defined as women physically capable of becoming pregnant unless the female subject cannot have children due to surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal). Fertile males of childbearing potential are defined as men who are sexually capable to impregnate the female partner even if surgically sterilized (i.e., vasectomy).
  • highly effective methods of contraception include intra-uterine device (IUD) and hormonal contraception (oral, injectable, patches or implant)
  • effective methods of contraception include barrier methods (latex condom, diaphragm with spermicide, cervical cap, sponge)
  • when possible, subjects should be strongly encouraged to include at least one highly effective method of contraception
  • Male subjects must agree to use appropriate method of barrier contraception (latex condom with a spermicidal agent) or abstain completely from heterosexual intercourse fro the time of informed consent and for 120 days following last dose of study drug unless female partner absolutely cannot have children because of surgery or for other medical reasons
  • Negative urine pregnancy test
  • Ability to understand and willingness to sign a written informed consent form
  • Able to comply with study visit schedule and assessments

Who cannot join

  • Subject has received:
  • chemotherapy or small molecular targeted therapy <2 weeks prior to W1D1
  • approved antibody therapy <5 half-lives from W1D1 (or 4 weeks since last therapy, whichever is the shortest)
  • local palliative radiation <14 days from W1D1
  • invasive surgery requiring general anesthesia <30 days from W1D1
  • chemotherapy with nitrosoureas or mitomycin C <45 days from W1D1
Show all 43Show fewer
  • Uncontrolled grade 2 or greater toxicity except alopecia related to any prior treatment (i.e., chemotherapy, targeted therapy, radiation or surgery) within 7 days prior to W1D1 unless approved by the Medical Monitor
  • Prolongation of QT/QTc interval (QTc interval >470) using the Fredericia method of QTc analysis
  • Women who are pregnant or nursing
  • Any known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) or any concurrent infection requiring IV antibiotics
  • Any known clinically significant or concurrent acute liver disease, including viral hepatitis
  • Primary brain malignant tumors
  • Subjects with uncontrolled symptomatic central nervous system (CNS) involvement
  • Subjects requiring steroids at stable dose (>4 mg/day dexamethasone or equivalent) for at least 2 weeks
  • Uncontrolled hypertension >150/100 mmHg
  • Concurrent participation in any other investigational therapeutic study, unless non-interventional study and approved by Sponsor
  • History of stroke, deep venous thrombosis (DVT), transient ischemic attack (TIA), unstable angina, or myocardial infarction within 3 months prior to W1D1
  • Uncontrolled concurrent disease or illness including but not limited to:
  • symptomatic congestive heart failure (NYHA Class III or IV) per the NYHA Classification, unstable angina pectoris, clinically significant cardiac arrhythmia
  • unstable or untreated cardiac conditions or ejection fraction of <50% as determined by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
  • diabetes mellitus (i.e., fasting blood glucose >220 despite acceptable chronic diabetes therapy)
  • psychiatric illness that would limit compliance with study requirements, as determined by the Investigator
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for the study.
  • Known hypersensitivity to any component of CRLX101 or excipient or documented medical condition that would prohibit adequate pre-medication with antihistamine.
  • Presence of ≥Grade 1 cystitis
  • Minor surgical procedure, excluding placement of a vascular access device, within 24 hours prior to W1D1.
  • Cardiovascular disease defined as congestive heart failure (NYHA Class II, III, or IV) per the NYHA Classification, angina pectoris requiring nitrate therapy, or myocardial infarction within the last 6 months prior to therapy
  • Uncontrolled hypertension (defined as the presence of systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg on two separate occasions. Blood pressure must be controlled to a systolic blood pressure <150 mmHg and/or to diastolic blood pressure <100 mmHg prior to study treatment), or any prior history of hypertensive crisis or hypertensive encephalopathy
  • Peripheral vascular disease >Grade 1
  • Known congenital long QT syndrome, history of torsades de pointes or ventricular tachycardia.
  • Known history of pulmonary hypertension or non-infectious interstitial pneumonitis.
  • History or evidence of thrombotic or hemorrhagic disorders: including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA), intracerebral hemorrhage or sub- arachnoid hemorrhage ≤ 6 months prior to W1D1
  • Chronic daily aspirin >325 mg/day or clopidogrel (>75 mg/day)
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization
  • Any of the following serious, non-healing conditions:wound, ulcer, or bone fracture
  • Proteinuria at screening as demonstrated by either: urine dipstick ≥2+ (subjects discovered to have a ≥2+ proteinuria on dipstick urinalysis at baseline should undergo 24-hour urine collection and must demonstrate <1g of protein in 24 hours to be eligible): 24-hour urine collection demonstrates >1g of protein in 24 hours
  • Immunocompromised subjects, including known seropositivity for human immunodeficiency virus (HIV), or current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen [HbsAg] or antibody to hepatitis C virus [anti HCV] with confirmatory testing). [Note: testing is not mandatory to be eligible for the study. However, if a subject is at risk for having undiagnosed hepatitis C virus (HCV) (due to history of injection drug use or due to geographic location for example), testing at screening should be considered]
  • Chronic treatment with corticosteroids (prednisone >12.5 mg/day or dexamethasone >2 mg/day excluding inhaled steroids
  • Known hypersensitivity to 5FU, oxaliplatin or other platinum agent, or to their excipients
  • Known dihydropyridine dehydrogenase (DPD) enzyme deficiency (testing not required)
  • Baseline peripheral neuropathy grade ≥ 2
  • Progressive disease within ≤ 6 months of completing an oxaliplatin containing adjuvant therapy
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • START Midwest/Cancer & Hematology Centers of Western Michigan, PC

    Grand Rapids, Michigan, 49503

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • South Texas Accelerated Research Therapeutics (START), LLC

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Evaluation of an Alternative Schedule for CRLX101 Alone in Combination With Bevacizumab and in Combination With mFOLFOX6 in Subjects With Advanced Solid Tumor Malignancies

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of weekly dosing of CRLX101 (both as monotherapy; (Schedule 1) and in combination with bevacizumab every 2 weeks (Schedule 2) and weekly with a 3 week on / 1 week off schedule in combination with mFOLFOX6 (Schedule 3) to affirm the dose for future clinical studies.

Read the detailed description

This is an open-label, dose escalation study. Subjects enrolled in Schedule 1 will receive weekly CRLX101 alone. The starting dose for Schedule 1 is 12 mg/m^2 and the next dose level is 15 mg/m^2 (or 10 mg/m^2 if 12 mg/m^2 is not well tolerated). No other dose levels in Schedule 1 will be explored.

Subjects enrolled in Schedule 2 will receive weekly CRLX101 in combination with bi-weekly bevacizumab (10 mg/kg) The starting dose for Schedule 2 is 12 mg/m^ and the next dose is 15 mg/m^2. No other dose levels in Schedule 2 will be explored

Subjects enrolled in Schedule 3 will receive weekly CRLX101 for 3 of every 4 weeks in combination with bi-weekly mFOLFOX6 (oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 and 5FU (fluorouracil) 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous infusion). The starting dose for Schedule 3 is 12 mg/m^2 and the next dose is 15 mg/m^2.

In the absence of dose-limiting toxicities (DLTs) additional subjects may be enrolled (expansion cohort) at the same, intermediate or lower dose levels following consultation between the Investigator and Sponsor.

Enrollment of 6-8 subjects will occur in each cohort for all 3 Schedules.

The MTD is defined as the highest dose level at which fewer than 2 out of 6 subjects experience a DLT. RP2D will be selected based on overall tolerability data from all subjects treated at different dose cohorts in this study.

No intra-patient dose escalation is allowed.

Approximately 61 evaluable subjects are anticipated to be enrolled: 15 subjects in Schedule 1, 15 subjects in Schedule 2 and approximately 31 subjects are anticipated in Schedule 3 (approximately 16 in the dose escalation cohort and up to 15 in the expansion cohort).

The exact number of subjects is dependent on the actual number of subjects enrolled per cohort and the number of cohorts investigated.

Conditions
Solid Tumors
Being tested
CRLX101, Bevacizumab, mFOLFOX6
Keywords
solid tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRLX101Drug

    Also called NLG207

    infusion CRLX101 weekly

  • BevacizumabDrug

    Also called Avastin

    infusion weekly CRLX101 + bevacizumab biweekly

  • mFOLFOX6Drug

    Also called oxaliplatin, leucovorin, 5FU

    infusion weekly CRLX101 for 3 or every 4 weeks and in combination with bi-weekly mFOLFOX6

Study groups in NCT02648711
Study groupRoleWhat they receive
CRLX101 aloneExperimentalSubjects will receive weekly infusion of CRLX101 alone. Starting dose is 12 mg/m^2 and the next dose level is 15 mg/m^2 (or 10 mg/m^2 if 12 mg/m^2 is not well tolerated. No other dose levels will be explored.
Receives: Drug: CRLX101
CRLX101 in combination with bevacizumabExperimentalSubjects receive weekly infusion of CRLX101 in combination with bi-weekly bevacizumab (10 mg/kg. The starting dose is 12 mg/m^2 and the next dose level is 15 mg/m^2. No other dose levels will be explored.
Receives: Drug: CRLX101; Drug: Bevacizumab
CRLX101 in combination with mFOLFOX6ExperimentalSubjects receive weekly infusion of CRLX101 for 3 of every 4 weeks in combination with bi-weekly mFOLFOX6 (oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 and 5FU 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous infusion). The starting dose is 12 mg/m^2 and the next dose level is 15 mg/m^2.
Receives: Drug: CRLX101; Drug: mFOLFOX6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D)

    To determine the maximum tolerated dose (MTD) / recommended Phase 2 dose (RP2D) of CRLX101 when administered by intravenous (IV) infusion every week (QW) alone (Schedule 1), (QW) in combination with bevacizumab (Q2W) (Schedule 2) and weekly with a 3-week on / 1-week off schedule in combination with mFOLFOX6 (Q2W) (Schedule 3) in subjects with advanced solid tumor malignancies

    Measured: 15 months

Secondary outcomes (8)

  1. Safety and Tolerability (Weekly Dosing) determined by reported adverse events, serious adverse events, physical exam findings, vital sign measurements,12-lead ECG readings, clinical lab evaluations, and treatment discontinuation due to toxicity.

    Will be determined by reported AEs, SAEs, physical exam findings, vital sign measurements,12-lead ECG readings, clinical lab evaluations, and treatment discontinuation due to toxicity.

    Measured: 15 months

  2. Pharmacokinetic Profile (PK) - Urine

    Urine samples will be collected to evaluate the urinary excretion of total and unconjugated drug before, during, and after infusion. PK parameters in urine will include the maximum concentration (Cmax), amount of drug in the urine, % of drug eliminated in the urine. PK parameters will be calculated using non-compartmental analysis. Actual sampling times will be used to calculate PK parameters in this study.

    Measured: 15 months

  3. Pharmacokinetic Profile (PK) - Plasma:CL

    Plasma PK parameters will include clearance (CL) for both total and unconjugated drug.

    Measured: 15 months

  4. Pharmacokinetic Profile (PK) - Plasma:Vd

    The plasma PK parameters will include volume of distribution (Vd)

    Measured: 15 months

  5. Pharmacokinetic Profile (PK) - Plasma:t1/2

    Plasma PK parameters will include half-life (t1/2)

    Measured: 15 months

  6. Pharmacokinetic Profile (PK) - Plasma:Cmax

    Plasma PK parameters will include maximum concentration (Cmax)

    Measured: 15 months

  7. Pharmacokinetic Profile (PK) - Plasma:AUC

    Plasma PK parameters will include area under the concentration versus time curve (AUC)

    Measured: 15 months

  8. Anti-tumor Activity

    To further explore preliminary signs of anti-tumor activity of CRLX101 when administered alone (Schedule 1) and in combination with bevacizumab (Schedule 2), and in combination with mFOLFOX6 (Schedule 3)

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2016 (estimated)
  2. Study startOct 2015
  3. Primary completion17 Oct 2017
  4. Study completion7 May 2018

Why it stopped: Company decision

Resources

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
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02648711
Sponsor's protocol ID
CRLX101-102
Status last verified
May 2020
First submitted
18 Nov 2015
Last updated
28 May 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Kummar S, Raffeld M, Juwara L, Horneffer Y, Strassberger A, Allen D, Steinberg SM, Rapisarda A, Spencer SD, Figg WD, Chen X, Turkbey IB, Choyke P, Murgo AJ, Doroshow JH, Melillo G. Multihistology, target-driven pilot trial of oral topotecan as an inhibitor of hypoxia-inducible factor-1alpha in advanced solid tumors. Clin Cancer Res. 2011 Aug 1;17(15):5123-31. doi: 10.1158/1078-0432.CCR-11-0682. Epub 2011 Jun 14.

    PubMed 21673063

  • Eliasof S, Lazarus D, Peters CG, Case RI, Cole RO, Hwang J, Schluep T, Chao J, Lin J, Yen Y, Han H, Wiley DT, Zuckerman JE, Davis ME. Correlating preclinical animal studies and human clinical trials of a multifunctional, polymeric nanoparticle. Proc Natl Acad Sci U S A. 2013 Sep 10;110(37):15127-32. doi: 10.1073/pnas.1309566110. Epub 2013 Aug 26.

    PubMed 23980155

  • Schluep T, Hwang J, Cheng J, Heidel JD, Bartlett DW, Hollister B, Davis ME. Preclinical efficacy of the camptothecin-polymer conjugate IT-101 in multiple cancer models. Clin Cancer Res. 2006 Mar 1;12(5):1606-14. doi: 10.1158/1078-0432.CCR-05-1566.

    PubMed 16533788

  • Numbenjapon T, Wang J, Colcher D, Schluep T, Davis ME, Duringer J, Kretzner L, Yen Y, Forman SJ, Raubitschek A. Preclinical results of camptothecin-polymer conjugate (IT-101) in multiple human lymphoma xenograft models. Clin Cancer Res. 2009 Jul 1;15(13):4365-73. doi: 10.1158/1078-0432.CCR-08-2619. Epub 2009 Jun 23.

    PubMed 19549776

  • Pham E, Birrer MJ, Eliasof S, Garmey EG, Lazarus D, Lee CR, Man S, Matulonis UA, Peters CG, Xu P, Krasner C, Kerbel RS. Translational impact of nanoparticle-drug conjugate CRLX101 with or without bevacizumab in advanced ovarian cancer. Clin Cancer Res. 2015 Feb 15;21(4):808-18. doi: 10.1158/1078-0432.CCR-14-2810. Epub 2014 Dec 18.

    PubMed 25524310

  • Gaur S, Chen L, Yen T, Wang Y, Zhou B, Davis M, Yen Y. Preclinical study of the cyclodextrin-polymer conjugate of camptothecin CRLX101 for the treatment of gastric cancer. Nanomedicine. 2012 Jul;8(5):721-30. doi: 10.1016/j.nano.2011.09.007. Epub 2011 Oct 25.

    PubMed 22033079

  • Rapisarda A, Melillo G. Overcoming disappointing results with antiangiogenic therapy by targeting hypoxia. Nat Rev Clin Oncol. 2012 Apr 24;9(7):378-90. doi: 10.1038/nrclinonc.2012.64.

    PubMed 22525710

  • Rapisarda A, Zalek J, Hollingshead M, Braunschweig T, Uranchimeg B, Bonomi CA, Borgel SD, Carter JP, Hewitt SM, Shoemaker RH, Melillo G. Schedule-dependent inhibition of hypoxia-inducible factor-1alpha protein accumulation, angiogenesis, and tumor growth by topotecan in U251-HRE glioblastoma xenografts. Cancer Res. 2004 Oct 1;64(19):6845-8. doi: 10.1158/0008-5472.CAN-04-2116.

    PubMed 15466170

  • Conley SJ, Baker TL, Burnett JP, Theisen RL, Lazarus D, Peters CG, Clouthier SG, Eliasof S, Wicha MS. CRLX101, an investigational camptothecin-containing nanoparticle-drug conjugate, targets cancer stem cells and impedes resistance to antiangiogenic therapy in mouse models of breast cancer. Breast Cancer Res Treat. 2015 Apr;150(3):559-67. doi: 10.1007/s10549-015-3349-8. Epub 2015 Apr 2.

    PubMed 25833208

  • Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N; AVOREN Trial investigators. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007 Dec 22;370(9605):2103-11. doi: 10.1016/S0140-6736(07)61904-7.

    PubMed 18156031

  • Weiss GJ, Chao J, Neidhart JD, Ramanathan RK, Bassett D, Neidhart JA, Choi CHJ, Chow W, Chung V, Forman SJ, Garmey E, Hwang J, Kalinoski DL, Koczywas M, Longmate J, Melton RJ, Morgan R, Oliver J, Peterkin JJ, Ryan JL, Schluep T, Synold TW, Twardowski P, Davis ME, Yen Y. First-in-human phase 1/2a trial of CRLX101, a cyclodextrin-containing polymer-camptothecin nanopharmaceutical in patients with advanced solid tumor malignancies. Invest New Drugs. 2013 Aug;31(4):986-1000. doi: 10.1007/s10637-012-9921-8. Epub 2013 Feb 9.

    PubMed 23397498

  • Griggs JJ, Mangu PB, Anderson H, Balaban EP, Dignam JJ, Hryniuk WM, Morrison VA, Pini TM, Runowicz CD, Rosner GL, Shayne M, Sparreboom A, Sucheston LE, Lyman GH; American Society of Clinical Oncology. Appropriate chemotherapy dosing for obese adult patients with cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2012 May 1;30(13):1553-61. doi: 10.1200/JCO.2011.39.9436. Epub 2012 Apr 2.

    PubMed 22473167

  • Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.

    PubMed 33532112

  • Keefe, SM, Heitjan D, Hennessy M., et al. Interim results of a phase 1b/2a study evaluating the nano pharmaceutical CRLX101 with bevacizumab (bev) in the treatment of subjects (pts) with refractory metastatic renal cell carcinoma (mRCC). J Clin Oncol 32, 2014 (suppl 4; abstr 412).

  • Yen et al, Final phase 1/2a results evaluating the cyclodextrin-containing nanoparticle CRLX101 in subjects with advanced solid tumor malignancies, 23rd EORTC-NCI-AACR, Nov 12-16, 2011: abstract A97

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CRLX101, Bevacizumab and mFOLFOX6 in people with Solid Tumors, run by NewLink Genetics Corporation 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 43 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 28 May 2020. 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 was stopped early (reason given: Company decision). 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?

Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) (time frame: 15 months). 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 NCT02648711, which also lists 39 linked publications.

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 28 May 2020.

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