Solid TumorsPhase 1NCT00635284

ABI-009 Trial in Patients With Advanced Non-hematologic Malignancies

A Phase 1 study testing ABI-009 in people with Solid Tumors, run by Celgene at 2 sites in United States.

Completed

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

Trial summary

To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 given weekly; to characterize the toxicities of ABI-009; and to determine the pharmacokinetic parameters for ABI-009 when given on a weekly schedule. 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?: ABI-009
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 2 sitesUnited States
Study dates: 1 Dec 2007to 1 Jun 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

Each subject must meet the following criteria to be enrolled in this study.
Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy.
Patients with advanced non-hematologic malignancies for whom no standard therapy exists.
Measurable disease by RECIST or evaluable disease (e.g., bone metastasis, pleural effusion, ascites, or lesions which do not fulfill RECIST criteria for metastatic disease)
Off all therapy (inclusive of investigational therapies) for at least 4 weeks prior to study drug administration OR off all daily or weekly therapy (inclusive of investigational therapies) for at least 2 weeks prior to study drug administration and without any side effects associated with these therapies.
Female patients of child-bearing potential must have a negative serum pregnancy test within 7 days prior to first study drug administration.

Show all 28Show fewer

Female patients who are postmenopausal must have 12 months of amenorrhea, surgically sterile, or must agree to the use of a physical method of non-hormonal contraception.
Male patients must be surgically sterile or agree to the use of a barrier method of contraception.
Life expectancy of > 3 months.
ECOG Performance Status of 0-1.
Patients must be able to provide informed consent indicating knowledge of his/her disease process, the investigational nature of the therapy, alternatives, benefits, and risks including potential side effects.
Age ≥ 18 years of age.
No major surgery within 4 weeks before treatment with ABI-009. (A biopsy is not considered major surgery).
No chemotherapy, hormonal therapy, immunotherapy or radiotherapy within 4 weeks before treatment with ABI-009 (6 weeks for previous treatment with nitrosoureas, mitomycin, or extensive radiotherapy) and no immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
No immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
Required Initial Laboratory Data:
Hemoglobin > 9.0 g/dL
WBC ≥ 3,000/µl
ANC ≥ 1,500/µl
Platelet count ≥ 100,000/µl
Total Bilirubin ≤ ULN
SGOT (AST) SGPT (ALT) ≤ 1.5 x ULN ≤ 1.5 x ULN
Serum Cholesterol < 350 mg/dL
Serum Triglyceride < 300 mg/dL
Adequate renal function with serum creatinine < 1.5 mg/dL and/or creatinine clearance (cockroft formula) ≥ 60 mL/min.
No active alcohol abuse, drug addiction, or psychotic disorders.
No known concomitant genetic or acquired immunosuppressive diseases (such as AIDS).
If obese, a patient must be treated with doses calculated using his/her actual BSA (The physician must be comfortable treating at the full BSA dose regardless of BSA).

Who cannot join

Subjects who meet any of the following criteria will be excluded from the study.
Pregnant or nursing women.
History of allergic reactions attributed to compounds of similar chemical or biologic composition including macrolide (e.g. azithromycin, clarithromycin, dirithromycin, and erythromycin) and ketolide antibiotics.
Patients have not recovered from adverse affects of radiation therapy or investigational agent within previous 28 days.
Uncontrolled intercurrent illness that in the opinion of the investigator would limit compliance and tolerance to study requirements
Patients with known brain metastases or leptomeningeal tumor involvement.
Receiving any of the following: concomitant antitumor therapy or inhibitors of CYP3A4.
Patients with history of interstitial lung disease and/or pneumonitis.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Sarcoma Oncology Center
Santa Monica, California, 90403

Other trials in United States

About this study

Official title: A Phase I Trial of ABI-009 (Nab-rapamycin) Administered Weekly in Patients With Advanced Non-hematologic Malignancies

Read the detailed description

No extended description necessary

Conditions: Solid Tumors
Being tested: ABI-009

What participants receive

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

ABI-009Drug
Also called nab-rapamycin
nab-rapamycin

Study groups in NCT00635284
Study group	Role	What they receive
ABI-009	Experimental	Not described Receives: Drug: ABI-009

What is being measured

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

Determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 administered weekly and pharmacokinetic parameters for ABI-009.
Measured: End of Study (EOS) and Follow Up

Secondary outcomes (1)

Efficacy of ABI-009 in this patient population
Measured: End of Study (EOS) and Follow Up

Timeline

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

1 Dec 20071 Jun 2011

First posted13 Mar 2008 (estimated)
Study start1 Dec 2007
Primary completion1 Jun 2011
Study completion1 Jun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorsStudies of the same condition, open and under way.
More trials run by CelgeneThe 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: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00635284
Sponsor's protocol ID: CA401
Status last verified: Oct 2019
First submitted: 7 Mar 2008
Last updated: 18 Oct 2019
Results posted: No
Data monitoring committee: No

Publications

Gonzalez-Angulo AM, Meric-Bernstam F, Chawla S, Falchook G, Hong D, Akcakanat A, Chen H, Naing A, Fu S, Wheler J, Moulder S, Helgason T, Li S, Elias I, Desai N, Kurzrock R. Weekly nab-Rapamycin in patients with advanced nonhematologic malignancies: final results of a phase I trial. Clin Cancer Res. 2013 Oct 1;19(19):5474-84. doi: 10.1158/1078-0432.CCR-12-3110.
PubMed 24089446

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Trial of ABI-009 (Nab-rapamycin) Administered Weekly in Patients With Advanced Non-hematologic Malignancies
ClinicalTrials.gov ID: NCT00635284
Acronym / sponsor ID: CA401
Conditions: Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: CelgeneIndustry (pharma, biotech, devices)
Study start: 1 Dec 2007 (actual)
Primary completion: 1 Jun 2011 (actual)
Study completion: 1 Jun 2011 (actual)
First posted: 13 Mar 2008 (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.

Detailed description

No extended description necessary

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ABI-009	Experimental	Drug: ABI-009

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (28 listed)

Each subject must meet the following criteria to be enrolled in this study.
Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy.
Patients with advanced non-hematologic malignancies for whom no standard therapy exists.
Measurable disease by RECIST or evaluable disease (e.g., bone metastasis, pleural effusion, ascites, or lesions which do not fulfill RECIST criteria for metastatic disease)
Off all therapy (inclusive of investigational therapies) for at least 4 weeks prior to study drug administration OR off all daily or weekly therapy (inclusive of investigational therapies) for at least 2 weeks prior to study drug administration and without any side effects associated with these therapies.

Key exclusion criteria (8 listed)

Subjects who meet any of the following criteria will be excluded from the study.
Pregnant or nursing women.
History of allergic reactions attributed to compounds of similar chemical or biologic composition including macrolide (e.g. azithromycin, clarithromycin, dirithromycin, and erythromycin) and ketolide antibiotics.
Patients have not recovered from adverse affects of radiation therapy or investigational agent within previous 28 days.
Uncontrolled intercurrent illness that in the opinion of the investigator would limit compliance and tolerance to study requirements

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
ABI-009Also: nab-rapamycinnab-rapamycin	Drug	ABI-009

Primary outcome

Determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 administered weekly and pharmacokinetic parameters for ABI-009.
Time frame: End of Study (EOS) and Follow Up

1 secondary outcome

Efficacy of ABI-009 in this patient population
Time frame: End of Study (EOS) and Follow Up

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 18 Oct 2019.
Background: PubMed 24089446Gonzalez-Angulo AM, Meric-Bernstam F, Chawla S, Falchook G, Hong D, Akcakanat A, Chen H, Naing A, Fu S, Wheler J, Moulder S, Helgason T, Li S, Elias I, Desai N, Kurzrock R. Weekly nab-Rapamycin in patients with advanced nonhematologic malignancies: final results of a phase I trial. Clin Cancer Res. 2013 Oct 1;19(19):5474-84. doi: 10.1158/1078-0432.CCR-12-3110.

Related trials for Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

Ana M. Gonzalez, MD principal investigator

M.D. Anderson Cancer Center

Sant P. Chawla, MD principal investigator

Sarcoma Oncology Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABI-009 in people with 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 28 inclusion and 8 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 18 Oct 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 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?

Determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 administered weekly and pharmacokinetic parameters for ABI-009. (time frame: End of Study (EOS) and Follow Up). 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 NCT00635284, which also lists 1 linked publication.

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 18 Oct 2019.