Metastatic Breast CancerPhase 2NCT00645177
Phase 2 Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone to Treat Metastatic Breast Cancer
A Phase 2 study testing ABT-869 and paclitaxel in people with Metastatic Breast Cancer, run by AbbVie (prior sponsor, Abbott) at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine the effect of ABT-869 plus paclitaxel compared to paclitaxel alone on disease progression in metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- ABT-869 and paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2008to Dec 2009
- Phase
- Phase 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be female and > 18 years of age.
- Subject must be diagnosed with adenocarcinoma of the breast.
- Subject must have metastatic disease or locally recurrent disease that is not amenable to surgical resection with curative intent.
- No prior chemotherapy for locally recurrent or metastatic breast cancer.
- At least 12 months since prior adjuvant or neoadjuvant chemotherapy (including prior taxane therapy and prior anti-angiogenic therapy [i.e. bevacizumab or a TKI]).
- No HER-2 -over-expression (3+) breast cancer (unless treated with trastuzumab or lapatinib).
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- Subject has measurable disease by RECIST criteria (randomized portion only).
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
- Subject must have adequate bone marrow, renal and hepatic function.
- Subject must have PTT < 1.5 x ULN and INR < 1.5.
Who cannot join
- Subject has received anti-cancer therapy (other than chemotherapy) including investigational agents, or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to Study Day 1.
- Subject has not recovered to less than or equal to grade 1 clinically significant adverse effects/toxicities of the previous therapy.
- Subject has received radiation therapy within 14 days of Study Day 1.
- Subject has received anti-cancer hormonal therapy within 14 days of Study Day 1.
- Subject has undergone major surgery within 21 days of Study Day 1.
- The subject has untreated brain or meningeal metastases.
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- Subject is receiving therapeutic anticoagulation therapy.
- Subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis).
- Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.
- Subject has a history of myocardial infarction, stroke, or transient ischemic attack (TIA) within 6 months of study day 1.
- Subject has a documented left ventricular (LV) ejection fraction < 50%
- Subject has known autoimmune disease with renal involvement.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Site Reference ID/Investigator# 6920
Harvey, Illinois, 60426
Site Reference ID/Investigator# 8352
San Francisco, California, 94115
About this study
Official title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone as First-line Treatment in Subjects With Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to determine the effect of ABT-869 plus paclitaxel compared to paclitaxel alone on disease progression in metastatic breast cancer.
Read the detailed description
Only the open-label lead-in portion of the study was enrolled (n=10). The randomized portion was not initiated. N = approximately 102 (90 randomized in a 1:1 ratio in Phase 2, approximately 6-12 enrolled in open-label lead-in to assess the tolerability of the combination) Phase 2, randomized, placebo-controlled, double-blind, multi-center study of the efficacy and tolerability of the ABT-869 + paclitaxel versus placebo for ABT-869 + paclitaxel in subjects with documented metastatic breast cancer in the first line metastatic therapy setting. An initial open-label, lead-in cohort of six subjects will be monitored for 2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20 mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities prohibit the cohort from continuing on to Cycle 3. Alternative doses may be explored based on the tolerability of the combination.
- Conditions
- Metastatic Breast Cancer
- Being tested
- ABT-869, paclitaxel, Placebo for ABT-869
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-869Drug
0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle
paclitaxelDrug
90 mg/m2 IV infusion over 1 hour, weekly every 3 out of 4 weeks
Placebo for ABT-869Drug
0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | In study, this arm is a randomized (blinded) to ABT-869 arm plus paclitaxel.
Note: Prior to randomization, approximately 6-12 subjects will be enrolled in open-label lead-in to assess the tolerability of the combination. The initial open-label, lead-in cohort of six subjects will be monitored for 2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20 mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities prohibit the cohort from continuing on to Cycle 3.
Alternative doses may be explored based on the tolerability of the combination Receives: Drug: ABT-869; Drug: paclitaxel |
| B | Placebo comparator | In study, this arm is a randomized (blinded) to placebo for ABT-869 plus paclitaxel arm.
Note: Prior to randomization, approximately 6-12 subjects will be enrolled in open-label lead-in to assess the tolerability of the combination. The initial open-label, lead-in cohort of six subjects will be monitored for 2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20 mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities prohibit the cohort from continuing on to Cycle 3.
Alternative doses may be explored based on the tolerability of the combination Receives: Drug: paclitaxel; Drug: Placebo for ABT-869 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: Radiographic evaluation every 3 months, clincial evaluation monthly
Secondary outcomes (1)
Overall survival
Measured: Subject death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Justin L. Ricker, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645177
- Sponsor's protocol ID
- M10-265
- Other IDs
- 2007-005905-23
- Status last verified
- Jan 2013
- First submitted
- 24 Mar 2008
- Last updated
- 29 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone as First-line Treatment in Subjects With Locally Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00645177
- Acronym / sponsor ID
- M10-265
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 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.
The purpose of this study is to determine the effect of ABT-869 plus paclitaxel compared to paclitaxel alone on disease progression in metastatic breast cancer.
Detailed description
Only the open-label lead-in portion of the study was enrolled (n=10). The randomized portion was not initiated. N = approximately 102 (90 randomized in a 1:1 ratio in Phase 2, approximately 6-12 enrolled in open-label lead-in to assess the tolerability of the combination) Phase 2, randomized, placebo-controlled, double-blind, multi-center study of the efficacy and tolerability of the ABT-869 + paclitaxel versus placebo for ABT-869 + paclitaxel in subjects with documented metastatic breast cancer in the first line metastatic therapy setting. An initial open-label, lead-in cohort of six subjects will be monitored for 2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20 mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities prohibit the cohort from continuing on to Cycle 3. Alternative doses may be explored based on the tolerability of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ABT-869, Drug: paclitaxelIn study, this arm is a randomized (blinded) to ABT-869 arm plus paclitaxel. Note: Prior to randomization, approximately 6-12 subjects will be enrolled in open-label lead-in to assess the tolerability of the combination. The initial open-label, lead-in cohort of six subjects will be monitored for 2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20 mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities prohibit the cohort from continuing on to Cycle 3. Alternative doses may be explored based on the tolerability of the combination |
| B | Placebo comparator | Drug: paclitaxel, Drug: Placebo for ABT-869In study, this arm is a randomized (blinded) to placebo for ABT-869 plus paclitaxel arm. Note: Prior to randomization, approximately 6-12 subjects will be enrolled in open-label lead-in to assess the tolerability of the combination. The initial open-label, lead-in cohort of six subjects will be monitored for 2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20 mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities prohibit the cohort from continuing on to Cycle 3. Alternative doses may be explored based on the tolerability of the combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must be female and > 18 years of age.
- Subject must be diagnosed with adenocarcinoma of the breast.
- Subject must have metastatic disease or locally recurrent disease that is not amenable to surgical resection with curative intent.
- No prior chemotherapy for locally recurrent or metastatic breast cancer.
- At least 12 months since prior adjuvant or neoadjuvant chemotherapy (including prior taxane therapy and prior anti-angiogenic therapy [i.e. bevacizumab or a TKI]).
Key exclusion criteria (12 listed)
- Subject has received anti-cancer therapy (other than chemotherapy) including investigational agents, or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to Study Day 1.
- Subject has not recovered to less than or equal to grade 1 clinically significant adverse effects/toxicities of the previous therapy.
- Subject has received radiation therapy within 14 days of Study Day 1.
- Subject has received anti-cancer hormonal therapy within 14 days of Study Day 1.
- Subject has undergone major surgery within 21 days of Study Day 1.
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 |
|---|---|---|
| ABT-8690.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle | Drug | A |
| paclitaxel90 mg/m2 IV infusion over 1 hour, weekly every 3 out of 4 weeks | Drug | A, B |
| Placebo for ABT-8690.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle | Drug | B |
Primary outcome
Progression-free survival
Time frame: Radiographic evaluation every 3 months, clincial evaluation monthly
1 secondary outcome
Overall survival
Time frame: Subject death
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 29 Jan 2013.
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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.
Justin L. Ricker, MD study director
AbbVie
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-869 and paclitaxel in people with Metastatic Breast Cancer, run by AbbVie (prior sponsor, Abbott) at 3 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 10 inclusion and 12 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 29 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 3 sites in United States, Mexico. 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. Some participants in this study may receive a placebo. 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 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 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?
Progression-free survival (time frame: Radiographic evaluation every 3 months, clincial evaluation monthly). 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 29 Jan 2013.