Locally Advanced Esophageal or GE Junction CancerPhase 1/2NCT00561197
An Open-label, Single-center, Phase 1/ 2 Study of Chemoradiotherapy and AT-101 in Patients With Locally Advanced Esophageal or Gastroesophageal Junction Cancer
A Phase 1/2 study testing AT-101 in people with Locally Advanced Esophageal or GE Junction Cancer, run by Ascenta Therapeutics at 1 site in United States.
Trial summary
This is a Phase 1/ 2, open-label, single-center study of preoperative chemoradiotherapy and AT-101 in patients with locally advanced esophageal or gastroesophageal junction cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Esophageal or GE Junction Cancer
- What is being tested?
- AT-101
- Type of treatment
- Injection or infusion
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2010
- 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 or female patients age ≥18 years
- Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction.
- For Phase 1: Phase 1 patients must have unresectable disease (Stage II to IVa). A patient can be unresectable for medical reasons or technical reasons but eligible for chemoradiation.
- For Phase 2: Phase 2 patients must have resectable cancer defined as: T2, T3, N0; OR T1-3, N+
- Patients must have archived tumor tissue to correlate tumor biomarker expression with clinical response. Availability of tumor specimens in paraffin blocks or at least two unstained slides must be confirmed prior to study entry. Results will not be used to determine patient eligibility for the study.
- ECOG performance status 0-1
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- Adequate hematologic function
- Adequate liver and renal function
- Ability to swallow and retain oral medication.
Who cannot join
- Patients with distant metastasis, including M1b lymph node status. (M1b status allowed on Phase I only for patients appropriate for chemoradation). Lymph nodes suspicious of M1b status by diagnostic imaging must be verified by fine-needle aspiration cytology. (Phase 2 only)
- For Phase 2: Patients with positive pleural, pericardial, or peritoneal cytology.
- For Phase 2: Patients with carcinoma of the cervical esophagus.
- For Phase 2: Patients with clinical evidence of metastasis to cervical or supraclavicular lymph nodes.
- Prior chemotherapy or radiotherapy for esophageal or gastroesophageal junction cancer. Phase 1 patients with prior chemotherapy are permitted to enter.
- Prior radiotherapy that would overlap the anticipated study treatment fields or radiotherapy to >30% of the marrow cavity (no prior chest irradiation).
- Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
- Pregnant or nursing females. Fertile patients (male and female) must use effective contraception.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase 1/ 2, open-label, single-center study of preoperative chemoradiotherapy and AT-101 in patients with locally advanced esophageal or gastroesophageal junction cancer.
- Being tested
- AT-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-101Drug
Patients will receive AT-101 starting at 10 mg once daily for 5 of 7 days in conjunction with RT (50.4 Gy for 28 fractions) for approximately 5.5 weeks. Concurrently, patients will receive docetaxel (20 mg/m2) IV weekly (Monday) and 5-fluorouracil (300 mg/m2) as a 24 hour continuous infusion for 5 of 7 days (Monday-Friday) of each RT week for approximately 5 weeks. Patients will continue for full 5.5 weeks unless unacceptable toxicity occurs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Safety and tolerability of AT-101 in combination with chemoradiotherapy, and determine a dose for Phase 2. Phase 2: Determine the pathologic complete response (pathCR) rate and to correlate tumor biomarker expression with clinical response.
Measured: 1 year
Secondary outcomes (1)
To assess the safety and toxicity of chemoradiotherapy and AT-101 in patients with esophageal or gastroesophageal junction cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Drug not being developed for this indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Esophageal or GE Junction CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascenta Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lance Leopold, MD, Study director, Ascenta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561197
- Sponsor's protocol ID
- AT-101-CS-102
- Status last verified
- Jan 2013
- First submitted
- 19 Nov 2007
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center, Phase 1/ 2 Study of Chemoradiotherapy and AT-101 in Patients With Locally Advanced Esophageal or Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT00561197
- Acronym / sponsor ID
- AT-101-CS-102
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug not being developed for this indication
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ascenta TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 Nov 2007 (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.
This is a Phase 1/ 2, open-label, single-center study of preoperative chemoradiotherapy and AT-101 in patients with locally advanced esophageal or gastroesophageal junction cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients age ≥18 years
- Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction.
- For Phase 1: Phase 1 patients must have unresectable disease (Stage II to IVa). A patient can be unresectable for medical reasons or technical reasons but eligible for chemoradiation.
- For Phase 2: Phase 2 patients must have resectable cancer defined as: T2, T3, N0; OR T1-3, N+
- Patients must have archived tumor tissue to correlate tumor biomarker expression with clinical response. Availability of tumor specimens in paraffin blocks or at least two unstained slides must be confirmed prior to study entry. Results will not be used to determine patient eligibility for the study.
Key exclusion criteria (8 listed)
- Patients with distant metastasis, including M1b lymph node status. (M1b status allowed on Phase I only for patients appropriate for chemoradation). Lymph nodes suspicious of M1b status by diagnostic imaging must be verified by fine-needle aspiration cytology. (Phase 2 only)
- For Phase 2: Patients with positive pleural, pericardial, or peritoneal cytology.
- For Phase 2: Patients with carcinoma of the cervical esophagus.
- For Phase 2: Patients with clinical evidence of metastasis to cervical or supraclavicular lymph nodes.
- Prior chemotherapy or radiotherapy for esophageal or gastroesophageal junction cancer. Phase 1 patients with prior chemotherapy are permitted to enter.
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 |
|---|---|---|
| AT-101Patients will receive AT-101 starting at 10 mg once daily for 5 of 7 days in conjunction with RT (50.4 Gy for 28 fractions) for approximately 5.5 weeks. Concurrently, patients will receive docetaxel (20 mg/m2) IV weekly (Monday) and 5-fluorouracil (300 mg/m2) as a 24 hour continuous infusion for 5 of 7 days (Monday-Friday) of each RT week for approximately 5 weeks. Patients will continue for full 5.5 weeks unless unacceptable toxicity occurs. | Drug | – |
Primary outcome
Phase 1: Safety and tolerability of AT-101 in combination with chemoradiotherapy, and determine a dose for Phase 2. Phase 2: Determine the pathologic complete response (pathCR) rate and to correlate tumor biomarker expression with clinical response.
Time frame: 1 year
1 secondary outcome
To assess the safety and toxicity of chemoradiotherapy and AT-101 in patients with esophageal or gastroesophageal junction cancer.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Drug not being developed for this indication). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
Related trials for Locally Advanced Esophageal or GE Junction Cancer
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Locally Advanced Esophageal or GE Junction Cancer
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.
Lance Leopold, MD study director
Ascenta Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AT-101 in people with Locally Advanced Esophageal or GE Junction Cancer, run by Ascenta Therapeutics at 1 site 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 9 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: stopped early, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Drug not being developed for this indication). 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?
Phase 1: Safety and tolerability of AT-101 in combination with chemoradiotherapy, and determine a dose for Phase 2. Phase 2: Determine the pathologic complete response (pathCR) rate and to correlate tumor biomarker expression with clinical response. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2013.