Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is AppropriatePhase 1NCT02162888
A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
A Phase 1 study testing Test Product (Bendamustine) in people with Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate, run by Eagle Pharmaceuticals, Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate
- What is being tested?
- Test Product (Bendamustine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2013to Nov 2014
- 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
- Histologically confirmed diagnosis of any malignant disease for which no curative or standard therapy is appropriate.
- Bone Marrow Function and Blood Chemistry results within protocol limits
Who cannot join
- CLL
- HIV
- Presence of brain metastases
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Regional Cancer Care Associates
Cherry Hill, New Jersey
Texas Oncology
Fort Worth, Texas
Greenville Hospital System University Medical Center
Greenville, South Carolina
Penn State University Hershey Medical Center
Hershey, Pennsylvania
Oncology Institute of Hope and Innovation
Long Beach, California
Virginia Oncology Associates
Norfolk, Virginia
Evergreen Hematology & Oncology
Spokane, Washington
Scott & White Healthcare
Temple, Texas
Cancer Center of Kansas
Wichita, Kansas
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington
About this study
The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer.
Read the detailed description
This is an open-label, randomized, crossover, Phase I study intended to demonstrate the BE, and safety and tolerability profile of 2 formulations of BDM HCl administered to cancer patients: Eagle-BDM and Teva-BDM Histologically confirmed diagnosis of any malignant disease (solid tumors and hematologic malignancies are eligible) for which no curative or standard therapy is appropriate.
At the end of the study, patients may be enrolled into an open-label extension (OLE) study (Study EGL-BDM-C-1301-OLE), at the discretion of the investigator.
- Being tested
- Test Product (Bendamustine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Product (Bendamustine)Drug
| Study group | Role | What they receive |
|---|---|---|
| Eagle-BDM; Teva-BDM; Teva-BDM | Other | Eagle-BDM: IV Teva-BDM: IV Receives: Drug: Test Product (Bendamustine) |
| Teva-BDM; Eagle-BDM;Teva-BDM | Other | Eagle-BDM: IV Teva-BDM: IV Receives: Drug: Test Product (Bendamustine) |
| Teva-BDM, Teva-BDM, Eagle-BDM | Other | Eagle-BDM: IV Teva-BDM: IV Receives: Drug: Test Product (Bendamustine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products
Each patient will receive 3, single doses of study medication in a 56 day treatment period (2 cycles of 28 days each). Medication will be administered on Cycle 1, Day 1; Cycle 1, Day 2; and Cycle 2, Day 1. Each patient will receive 1 dose of Eagle-BDM and 2 doses of Teva-BDM in 3 randomly assigned, varying treatment sequences(Eagle-BDM, Teva-BDM, Teva-BDM; Teva-BDM, Eagle-BDM, Teva-BDM; or Teva-BDM, Teva-BDM, Eagle-BDM). Pharmacokinetic assessments will be performed.
Measured: Participants will be in the study for up to 65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
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 Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is AppropriateStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eagle Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162888
- Sponsor's protocol ID
- EGL-BDM-C-1301
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2014
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheung EM, Edenfield WJ, Mattar B, Anthony SP, Mutch PJ, Chanas B, Smith M, Hepner A. Safety and Pharmacokinetics of Bendamustine Rapid-Infusion Formulation. J Clin Pharmacol. 2017 Nov;57(11):1400-1408. doi: 10.1002/jcph.942. Epub 2017 May 31.
PubMed 28561902
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
- ClinicalTrials.gov ID
- NCT02162888
- Acronym / sponsor ID
- EGL-BDM-C-1301
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Eagle Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Jun 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 demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer.
Detailed description
This is an open-label, randomized, crossover, Phase I study intended to demonstrate the BE, and safety and tolerability profile of 2 formulations of BDM HCl administered to cancer patients: Eagle-BDM and Teva-BDM Histologically confirmed diagnosis of any malignant disease (solid tumors and hematologic malignancies are eligible) for which no curative or standard therapy is appropriate.
At the end of the study, patients may be enrolled into an open-label extension (OLE) study (Study EGL-BDM-C-1301-OLE), at the discretion of the investigator.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eagle-BDM; Teva-BDM; Teva-BDM | Other | Drug: Test Product (Bendamustine)Eagle-BDM: IV Teva-BDM: IV |
| Teva-BDM; Eagle-BDM;Teva-BDM | Other | Drug: Test Product (Bendamustine)Eagle-BDM: IV Teva-BDM: IV |
| Teva-BDM, Teva-BDM, Eagle-BDM | Other | Drug: Test Product (Bendamustine)Eagle-BDM: IV Teva-BDM: IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed diagnosis of any malignant disease for which no curative or standard therapy is appropriate.
- Bone Marrow Function and Blood Chemistry results within protocol limits
Key exclusion criteria (3 listed)
- CLL
- HIV
- Presence of brain metastases
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 |
|---|---|---|
| Test Product (Bendamustine) | Drug | Eagle-BDM; Teva-BDM; Teva-BDM, Teva-BDM, Teva-BDM, Eagle-BDM, Teva-BDM; Eagle-BDM;Teva-BDM |
Primary outcome
To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products
Time frame: Participants will be in the study for up to 65 days
Each patient will receive 3, single doses of study medication in a 56 day treatment period (2 cycles of 28 days each). Medication will be administered on Cycle 1, Day 1; Cycle 1, Day 2; and Cycle 2, Day 1. Each patient will receive 1 dose of Eagle-BDM and 2 doses of Teva-BDM in 3 randomly assigned, varying treatment sequences(Eagle-BDM, Teva-BDM, Teva-BDM; Teva-BDM, Eagle-BDM, Teva-BDM; or Teva-BDM, Teva-BDM, Eagle-BDM). Pharmacokinetic assessments will be performed.
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 7 Jun 2021.
- Results publication: PubMed 28561902Cheung EM, Edenfield WJ, Mattar B, Anthony SP, Mutch PJ, Chanas B, Smith M, Hepner A. Safety and Pharmacokinetics of Bendamustine Rapid-Infusion Formulation. J Clin Pharmacol. 2017 Nov;57(11):1400-1408. doi: 10.1002/jcph.942. Epub 2017 May 31.
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.
10 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 Test Product (Bendamustine) in people with Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate, run by Eagle Pharmaceuticals, Inc. at 10 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 2 inclusion and 3 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 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products (time frame: Participants will be in the study for up to 65 days). 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 NCT02162888, 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 7 Jun 2021.