Locally Advanced Rectal CancerPhase 1NCT01589419
A Clinical Study Conducted in Multiple Centers Evaluating Escalating Doses of Veliparib in Combination With Capecitabine and Radiation in Patients With Locally Advanced Rectal Cancer
A Phase 1 study testing veliparib, capecitabine and radiation in people with Locally Advanced Rectal Cancer, run by AbbVie (prior sponsor, Abbott) at 6 sites in 2 countries.
Trial summary
An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with locally advanced rectal cancer (LARC). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- veliparib, capecitabine and radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jun 2012to Jan 2015
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be ≥ 18 years of age
- All subjects must have newly diagnosed, histologically proven adenocarcinoma of the rectum
- All subjects must have an abdominal/pelvis computed tomography (CT ) scan or magnetic resonance imaging (MRI) confirming no evidence of distant metastases
- Distal border of tumor < 12 cm from anal verge
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 2
- No prior treatment for LARC however prior treatments for other cancers are acceptable as long as they are considered curative
Who cannot join
- Subject is an unsuitable candidate for TME surgery
- Subject has received anticancer therapy
- Subject has received prior radiation therapy
- Subject has had major surgery within 28 days prior to the first dose of study drug
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Site Reference ID/Investigator# 68044
Chicago, Illinois, 60611
Site Reference ID/Investigator# 68045
Durham, North Carolina, 27710
Site Reference ID/Investigator# 112395
Goshen, Indiana, 46526
Site Reference ID/Investigator# 68043
Madison, Wisconsin, 53792
Site Reference ID/Investigator# 99095
Scottsdale, Arizona, 85258
About this study
Official title: An Open-Label Phase 1b Study of the Safety and Tolerability of Veliparib in Combination With Capecitabine and Radiation in Subjects With Locally Advanced Rectal Cancer (LARC)
An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with locally advanced rectal cancer (LARC).
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- veliparib, capecitabine, radiation
- Keywords
- DLT, radiation, veliparib, locally advanced rectal cancer, ABT-888, capecitabine, MTD, PARP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
veliparibDrug
Also called ABT-888
see arm description
capecitabineDrug
Also called Xeloda
see arm description
radiationRadiation
see arm description
| Study group | Role | What they receive |
|---|---|---|
| veliparib and capecitabine and radiation | Experimental | Veliparib on days 1-7, capecitabine and radiation on days 1-5 Receives: Drug: veliparib; Drug: capecitabine; Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)
Measured: From first study drug dose and at each weekly treatment visit until dose-limiting toxicities (DLT) observed or completion of dosing period (anticipated to be approximately 5 weeks).
Secondary outcomes (3)
Assess the safety (number of participants with adverse events and types of adverse events observed)
Measured: From screening and ongoing at each weekly treatment visit through dosing period (anticipated to be approximately 5 weeks), prior to surgery and at the final visit.
Assess the tolerability (number of participants with adverse events and types of adverse events observed)
Measured: From first study drug dose and ongoing at each weekly treatment visit, through completion of dosing period (anticipated to be approximately 5 weeks).
Assess the pharmacokinetic profile by area under the curve vs. dose of veliparib
Measured: Multiple measurements over time points (0, .5, 1, 2, 3, 4, 6 hours post dose) Day 1, Day 2 and at the pre-dose time point on Day 5 and week 2 visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2015
- Study completionJan 2015
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 Locally Advanced Rectal 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Komarnitsky, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589419
- Sponsor's protocol ID
- M12-950
- Status last verified
- Jan 2015
- First submitted
- 30 Apr 2012
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Czito BG, Deming DA, Jameson GS, Mulcahy MF, Vaghefi H, Dudley MW, Holen KD, DeLuca A, Mittapalli RK, Munasinghe W, He L, Zalcberg JR, Ngan SY, Komarnitsky P, Michael M. Safety and tolerability of veliparib combined with capecitabine plus radiotherapy in patients with locally advanced rectal cancer: a phase 1b study. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):418-426. doi: 10.1016/S2468-1253(17)30012-2. Epub 2017 Mar 27.
PubMed 28497757
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1b Study of the Safety and Tolerability of Veliparib in Combination With Capecitabine and Radiation in Subjects With Locally Advanced Rectal Cancer (LARC)
- ClinicalTrials.gov ID
- NCT01589419
- Acronym / sponsor ID
- M12-950
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- DLT, radiation, veliparib, locally advanced rectal cancer, ABT-888, capecitabine, MTD, PARP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 May 2012 (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.
An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with locally advanced rectal cancer (LARC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| veliparib and capecitabine and radiation | Experimental | Drug: veliparib, Drug: capecitabine, Radiation: radiationVeliparib on days 1-7, capecitabine and radiation on days 1-5 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be ≥ 18 years of age
- All subjects must have newly diagnosed, histologically proven adenocarcinoma of the rectum
- All subjects must have an abdominal/pelvis computed tomography (CT ) scan or magnetic resonance imaging (MRI) confirming no evidence of distant metastases
- Distal border of tumor < 12 cm from anal verge
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 2
Key exclusion criteria (5 listed)
- Subject is an unsuitable candidate for TME surgery
- Subject has received anticancer therapy
- Subject has received prior radiation therapy
- Subject has had major surgery within 28 days prior to the first dose of study drug
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
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 |
|---|---|---|
| veliparibAlso: ABT-888see arm description | Drug | veliparib and capecitabine and radiation |
| capecitabineAlso: Xelodasee arm description | Drug | veliparib and capecitabine and radiation |
| radiationsee arm description | Radiation | veliparib and capecitabine and radiation |
Primary outcome
Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)
Time frame: From first study drug dose and at each weekly treatment visit until dose-limiting toxicities (DLT) observed or completion of dosing period (anticipated to be approximately 5 weeks).
3 secondary outcomes
Assess the safety (number of participants with adverse events and types of adverse events observed)
Time frame: From screening and ongoing at each weekly treatment visit through dosing period (anticipated to be approximately 5 weeks), prior to surgery and at the final visit.
Assess the tolerability (number of participants with adverse events and types of adverse events observed)
Time frame: From first study drug dose and ongoing at each weekly treatment visit, through completion of dosing period (anticipated to be approximately 5 weeks).
Assess the pharmacokinetic profile by area under the curve vs. dose of veliparib
Time frame: Multiple measurements over time points (0, .5, 1, 2, 3, 4, 6 hours post dose) Day 1, Day 2 and at the pre-dose time point on Day 5 and week 2 visit.
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 20 Nov 2017.
- Results publication: PubMed 28497757Czito BG, Deming DA, Jameson GS, Mulcahy MF, Vaghefi H, Dudley MW, Holen KD, DeLuca A, Mittapalli RK, Munasinghe W, He L, Zalcberg JR, Ngan SY, Komarnitsky P, Michael M. Safety and tolerability of veliparib combined with capecitabine plus radiotherapy in patients with locally advanced rectal cancer: a phase 1b study. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):418-426. doi: 10.1016/S2468-1253(17)30012-2. Epub 2017 Mar 27.
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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.
Philip Komarnitsky, MD study director
AbbVie
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing veliparib, capecitabine and radiation in people with Locally Advanced Rectal Cancer, run by AbbVie (prior sponsor, Abbott) at 6 sites in 2 countries.
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 6 inclusion and 5 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. 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/or establish the recommended phase two dose (RPTD) (time frame: From first study drug dose and at each weekly treatment visit until dose-limiting toxicities (DLT) observed or completion of dosing period (anticipated to be approximately 5 weeks).). 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 NCT01589419, 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 20 Nov 2017.