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Advanced Solid TumorsPhase 1NCT01163071

A Phase 1 Trial of ABI-011 in Patients With Advanced Solid Tumors or Lymphomas

A Phase 1 study testing ABI-011 in people with Advanced Solid Tumors, run by Celgene at 2 sites in United States.

Terminated

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

Official record
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Trial summary

The purpose of this study is to determine the MTD and/or RP2D of ABI-011 when administered by IV on Day 1, Day 8 and Day 15 with one week of rest for patients with advanced solid tumor malignancies and lymphomas. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ABI-011
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
1 Mar 2011to 23 Sep 2011
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

  • Must be equal or greater 18 years of age
  • ECOG performance status less than or equal to 2 (Appendix 2)
  • Pts. must be willing and able to sign informed consent
  • Cytologically or histologically confirmed solid tumor malignancy or lymphoma for which no standard approved therapy is available. Patients should have accessible tumor lesions amendable to 2 serial biopsies which would not put the patient or their treatment at risk
  • Pt. agrees and is willing to provide 2 serial tumor biopsies(optional on first phase, mandatory on 2nd phase)
  • During the dose escalation phase, measurable or non-measurable disease as defined by RECIST criteria. At 2nd phase, only patients with measurable disease
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  • Life expectancy of equal or greater than 12 weeks
  • All AEs of any prior chemotherapy, surgery or radiotherapy, must have resolved to grade equal to or less than 1
  • The following laboratory results must be present within 14 days of initial ABI-011 administration
  • Hemoglobin greater or equal to 9g/dL
  • Absolute neutrophils count(ANC)greater or equal to 1.5 x 10^9/L
  • Platelet count is greater or equal to 100 x 10^9/L
  • Serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
  • Aspartate transaminase (AST) and alanine transaminase (ALT)is less than or equal to 2.5 ULN(except if liver metastases are present; then values must be less than or equal to 5 x ULN)
  • Potassium, corrected calcium and magnesium WNL
  • Serum Creatinine less than or equal to 1.5 x ULN
  • Activated aPTT,PT,INR,WNL
  • WNL levels : Troponin I and T, CK-MB,BNP
  • At least one measurable lesion should be evaluable (DCE-MRI eligibility criteria)and meet at least one of the criteria below:
  • At least one measurable lesions should be at least 3 cm in diameter and should not be near the diaphragm or mediastinum
  • Lesions should be solid masses that enhance with contrast, without signs of calcification on the most recent computed tomography (CT) or magnetic resonance (MRI)scan
  • Pts. must be willing to practice contraceptive methods for the duration of the study and for one month following study completion. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
  • Women of childbearing potential must have a negative serum pregnancy test(B-hCG)within 72 hours prior to first study drug administration

Who cannot join

  • Inability to comply with study and follow-up procedures
  • Women who are pregnant or lactating
  • Treatment with chemotherapy, hormonal therapy(except leuprolide for prostate cancer), immunotherapy, biologic therapy, or radiation therapy as cancer therapy within 4 weeks before initiation of study treatment. Six weeks should have elapsed if prior chemotherapy treatment included nitrosoureas or mitomycin C
  • Pts. who have received antibody-based therapies within 28 days or 5 half-lives of the agent, whichever time period is longer
  • Major surgery within 6 weeks before first study drug administration
  • Prior treatment with tumor vascular disruptive agents
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  • Any uncontrolled medical or psychiatric risk factors
  • Central nervous system(CNS)metastases.
  • History of diabetic retinopathy. All patients must be evaluated by an ophthalmologist prior to study treatment
  • Any history of myopathy, either peripheral or cardiac
  • Current use of medications that may have the potential of QTc prolongation
  • History of allergy or hypersensitivity to any compound of the ABI-011 formulation
  • Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
  • Pt.has known infection with human immunodeficiency virus (HIV),or known chronic Hepatitis B or Hepatitis C
  • Inability to be venipunctured and/or tolerate venous access
  • History of other carcinoma within past 5 years
  • Pts. requiring therapeutic anticoagulation with either coumadin or low molecular weight heparin or with history of any bleeding diathesis. Low dose aspirin and low dose coumadin for catheter maintenance are allowed
  • Lung tumors in a central position.
  • Cardiac exclusion criteria:
  • Left ventricular ejection fraction (LVEF)< 50% by echocardiography;
  • Previous history of MI or ischemic heart disease
  • EKG findings suggestive of current or previous ischemic heart disease, including left bundle branch block
  • Prior treatment with chemotherapy agents known to potentially cause cardiotoxicity
  • Class III or IV heart failure as defined by the New York Heart(NYHA) functional classification
  • Congenital or acquired long QT syndrome
  • Uncontrolled hypertension
  • Current or past history of clinically significant arrhythmias
  • QTc prolongation
  • HO Symptomatic PVD (Venous or arterial)
  • Seizure disease requiring current anticonvulsant treatment
  • HO previous CVA or TIA
  • HO inflammatory bowel disease (active or past) or active PUD
  • HO previous, whole abdomen radiation therapy or more than Grade 1 residual toxicity from previous radiation therapy.
  • History of autoimmune disease or vascular disease (venous or arterial)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Karmanos Cancer Center Institute

    Detroit, Michigan, 48201

  • CTRC @ The Utah Health Science Center @ San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase I Trial of ABI-011 Administered Weekly in Patients With Advanced Solid Tumors or Lymphomas

The purpose of this study is to determine the MTD and/or RP2D of ABI-011 when administered by IV on Day 1, Day 8 and Day 15 with one week of rest for patients with advanced solid tumor malignancies and lymphomas.

Read the detailed description

Dose limiting toxicities (DLT), maximum tolerated dose (MTD)

Being tested
ABI-011

What participants receive

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

  • ABI-011Drug

    ABI-011

Study groups in NCT01163071
Study groupRoleWhat they receive
ABI-011ExperimentalNot described
Receives: Drug: ABI-011

What is being measured

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

  1. DLT's and MTD Safety and Toxicity profile

    Evaluate PK and PD of ABI-011. Preliminary assessment of tumor response.

    Measured: During Cycle 1, treatment period, End of Study and Follow-Up, approximately up to 2 years

Secondary outcomes (5)

  1. Safety and toxicity profile of repeated dosing of ABI-011

    Number of subjects with Adverse Events; laboratory assessments, ECG assessments, opthalmologic assessments

    Measured: End of study and follow up, approximately up to 2 years

  2. Evaluate plasma PK of ABI-011 on this schedule

    Measured: End of Study and follow-up, Up to two years

  3. Assess biological activity and PD of ABI-011

    Measured: End of study and follow-up, approximately 2 years

  4. Make preliminary assessment of tumor response

    Measured: End of study and follow-up, approximately 2 years

  5. Assess biological activity/exploratory during treatment C1, C2, EOS

    Measured: End of Study and follow-up, aproximately two years

Timeline

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

  1. First posted15 Jul 2010 (estimated)
  2. Study start1 Mar 2011
  3. Primary completion23 Sep 2011
  4. Study completion23 Sep 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01163071
Sponsor's protocol ID
CA601
Status last verified
Nov 2019
First submitted
15 Jun 2010
Last updated
14 Nov 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABI-011 in people with Advanced Solid Tumors, run by Celgene at 2 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 34 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 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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?

DLT's and MTD Safety and Toxicity profile (time frame: During Cycle 1, treatment period, End of Study and Follow-Up, approximately up to 2 years). 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 NCT01163071.

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 14 Nov 2019.

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Clinical Trial NCT01163071 | AzTrials