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CancerPhase 1/2NCT00333502

Study of CRLX101 (NLG207) in the Treatment of Advanced Solid Tumors

A Phase 1/2 study testing Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer in people with Cancer and Solid Tumor, run by NewLink Genetics Corporation at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

CRLX101 is a nanopharmaceutical comprised of the chemotherapeutic camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Solid Tumor
What is being tested?
Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
3 sitesUnited States
Study dates
May 2006to Apr 2012
Phase
Phase 1/2
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 and female subjects >18 years of age with advanced, histologically-confirmed solid tumors refractory to standard therapy or for which no standard therapy exists and who have evidence of disease progression documented since their prior therapy.
  • Subjects must have measurable or evaluable disease.
  • Subjects must not have received prior chemotherapy or radiation for >/= 4 weeks prior to first dose of study drug.
  • Subjects may be entered if they have received prior radiation therapy involving </= 30% of the bone marrow. Any prior radiation therapy must have been administered >/= 4 weeks prior to first dose of study drug and the subject must be recovered from the acute toxic effects of the treatment prior to study entry.
  • Subjects may be enrolled with a history of treated brain metastases that are clinically stable for >/= 4 weeks prior to first dose of study drug. Subjects may not be currently receiving dexamethasone.
  • ECOG performance status of < 2.
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  • Life expectancy of greater than 12 weeks.
  • Subjects must have acceptable organ and marrow function at screening and pre-dose visits.
  • Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator and an acceptable QTc interval.
  • The effects of CRLX101 on the developing human fetus are unknown, therefore, women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Female subjects who are pregnant or nursing.
  • Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first dose of study drug or those who have not had adverse events return to baseline severity level or a severity level Grade 1 due to agents administered more than 4 weeks prior to first dose of study drug.
  • Subjects with a history of congestive heart failure (CHF) requiring medical therapy.
  • Subjects with serum amylase or lipase > 1.5X upper limit of normal (ULN).
  • Subjects with previous high dose chemotherapy with autologous stem cell rescue bone marrow transplantation.
  • Use of any investigational agent or drug within 4 weeks prior to first dose of study drug.
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  • Metastatic disease to the CNS requiring treatment or radiation therapy.
  • Subjects with known untreated brain metastases or treated brain metastases that have not been stable >/= 4 weeks prior to first dose of study drug.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.
  • The presence of active coagulation disorder.
  • Subjects with marked baseline prolongation of QT/QTc interval (QTc interval >/= 470 msec for females and QTc interval >/= 450 msec for males).
  • Any prior treatment with a topoisomerase I inhibitor.
  • Any major surgery </= 4 weeks prior to first dose of study drug.
  • Concurrent use of G-CSF or growth factors at the time of initiation of study drug.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • City of Hope National Medical Center

    Duarte, California, 91010

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Virginia G. Piper Cancer Center

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1b/2a Safety and Pharmacokinetic Study of CRLX101 (Formerly Named IT-101) in the Treatment of Advanced Solid Tumors

CRLX101 is a nanopharmaceutical comprised of the chemotherapeutic camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.

OBJECTIVES:

  • Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CRLX101 when administered intravenously to subjects with advanced solid tumors.
Conditions
Cancer, Solid Tumor
Being tested
Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer
Keywords
Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Lung Cancer,, Non Small Cell Lung Cancer, Pancreatic Cancer,, Breast Cancer, Colon Cancer, Endometrial Cancer,, Kidney (Renal Cell) Cancer, Melanoma, Prostate Cancer,, Skin Cancer, Thyroid Cancer,, Solid Malignancies
Medical subject headings
Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Breast Neoplasms, Colonic Neoplasms, Endometrial Neoplasms

What participants receive

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

  • Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymerDrug

    Also called NLG207, IT-101

    Subjects who meet inclusion/exclusion criteria will receive CRLX101 every other week.

Study groups in NCT00333502
Study groupRoleWhat they receive
CRLX101 (formerly known as IT-101)ExperimentalCRLX101 dosing per protocol dose escalation cohorts to MTD, then expansion cohort treated at MTD of CRLX101 15mg/m2
Receives: Drug: Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer

What is being measured

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

  1. To determine the safety, toxicity and maximum tolerated dose of CRLX101 when administered intravenously to subjects with advanced solid tumors.

    Measured: 6 months

Timeline

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

  1. First posted5 Jun 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionNov 2011
  4. Study completionApr 2012

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00333502
Sponsor's protocol ID
CRLX-001
Other IDs
City of Hope IRB number 05127
Status last verified
May 2020
First submitted
1 Jun 2006
Last updated
28 May 2020
Results posted
No

Publications

  • 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

  • Schluep T, Cheng J, Khin KT, Davis ME. Pharmacokinetics and biodistribution of the camptothecin-polymer conjugate IT-101 in rats and tumor-bearing mice. Cancer Chemother Pharmacol. 2006 May;57(5):654-62. doi: 10.1007/s00280-005-0091-7. Epub 2005 Aug 26.

    PubMed 16133526

  • Cheng J, Khin KT, Davis ME. Antitumor activity of beta-cyclodextrin polymer-camptothecin conjugates. Mol Pharm. 2004 May-Jun;1(3):183-93. doi: 10.1021/mp049966y.

    PubMed 15981921

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer in people with Cancer and Solid Tumor, 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 11 inclusion and 14 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 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

To determine the safety, toxicity and maximum tolerated dose of CRLX101 when administered intravenously to subjects with advanced solid tumors. (time frame: 6 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 NCT00333502, which also lists 3 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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