CancerPhase 1/2NCT01325441
A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies
A Phase 1/2 study testing BBI608 and Paclitaxel in people with Cancer, run by Sumitomo Pharma America, Inc. at 22 sites in 2 countries.
Trial summary
This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- BBI608 and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 565 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Apr 2011to 1 Jun 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
- A histologically or cytologically confirmed ovarian, breast, non-small cell lung, melanoma, gastric/GEJ/esophageal or other type of advanced cancer that is metastatic, unresectable, or recurrent and for which weekly paclitaxel is an acceptable therapeutic option.
- Patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer must also meet the following criteria: a. Must be either platinum-resistant or platinum-refractory according to the following definitions:(1)Platinum-resistant: a response to platinum therapy followed by progression within 6 months after completing therapy (2)Platinum-refractory: best response of stable disease or progression during platinum therapy; b. Must have had prior systemic treatment with a taxane; c. Must have received no more than 4 prior systemic cytotoxic regimens
- Patients with melanoma must also meet the following criteria: a. If melanoma is BRAF wild-type or has BRAF mutations that are not amenable to BRAF inhibitor therapy, and the patient is a candidate for immunotherapy, must have received ipilimumab; b. If melanoma is positive for the V600E or V600K BRAF mutation, must have received at least one line of prior therapy with a BRAF-specific inhibitor; either alone or in combination.
- Patients with triple negative breast cancer (estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), and human epidermal growth factor receptor 2-negative (Her2-) must also meet the following criteria: a. Must have received at least one prior chemotherapy regimen for locally advanced or metastatic disease; b. Must have received prior taxane therapy.
- Patients with NSCLC (adenocarcinoma, squamous, or adenosquamous histopathology) must also meet the following criteria: a. Must have disease that is stage IIIB, not curable by surgery or radiotherapy, or stage IV; b. Must have received at least one prior chemotherapy regimen for locally advanced or metastatic disease; c. EGFR-positive or ALK-positive patients must have received at least one line of EGFR-directed or ALK-directed therapy, respectively; d. Must have received prior taxane therapy.
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- Patients with adenocarcinoma arising from the esophagus, gastroesophageal junction, or stomach must also meet the following criteria: a. Must have received prior treatment with a platinum/fluoropyrimidine-based therapy with or without an anthracycline in the metastatic setting; or, in the adjuvant setting if recurrence occurred within 6 months of completing systemic adjuvant treatment; b. Patients with HER2 positive tumors must have had prior treatment with a Her2 inhibitor (e.g. trastuzumab or lapatinib); c. Patients who have received prior taxane therapy may be enrolled.
- Patients with thymic carcinoma must have received at least one prior systemic chemotherapy regiment for metastatic, recurrent, locally advanced or otherwise unresectable disease.
- ≥ 18 years of age
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1, see Section 9)
- Karnofsky performance Status ≥ 70% (Section 15)
- Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI608 dose
- Females of childbearing potential must have a negative serum pregnancy test
- Aspartate transaminase (AST) and alanine transaminase (ALT) £1.5 × upper limit of normal (ULN), or ≤ 2.5 × ULN with metastatic liver disease
- Hemoglobin (Hgb) ≥ 10 g/dl
- Total bilirubin £ 1.5 × ULN
- Creatinine £ 1.5 ´ ULN or creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Absolute neutrophil count ³ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Life expectancy ≥ 3 months
Who cannot join
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose provided all treatment-related adverse events have resolved or have been deemed irreversible, with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 7 days before beginning the administration of BBI608.
- Surgery within 4 weeks prior to first dose
- Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated
- Pregnant or breastfeeding
- Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
- Unable or unwilling to swallow BBI608 capsules daily
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- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
- Known severe hypersensitivity to paclitaxel
- Abnormal ECGs (ie, QT prolongation - QTc > 480 msec, signs of cardiac enlargement or hypertrophy, bundle branch block, signs of ischemia or necrosis and Wolff Parkinson White patterns)
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States17 sites
New York Oncology Hematology, P.C.
Albany, New York, 12206
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Virginia Cancer Specialists, P.C.
Fairfax, Virginia, 22031
Texas Oncology- Fort Worth
Fort Worth, Texas, 76104
Prisma Health (formerly Institute for Translational Oncology Research)
Greenville, South Carolina, 29605
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee, 37920
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
USC - University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Virginia Oncology Associates
Norfolk, Virginia, 23502
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Texas Oncology- Tyler
Tyler, Texas, 75702
Compass Oncology- Northwest Cancer Specialists
Vancouver, Washington, 98684
Canada5 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
St. Mary's Hospital
Montreal, Quebec, H3T 1M5
McGill University Health Center-Glenn Site
Montreal, Quebec, H4A 3J1
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies
This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced malignancies.
Read the detailed description
This is an open label, multi-center, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced solid tumors for whom weekly paclitaxel is an acceptable option.
- Conditions
- Cancer
- Being tested
- BBI608, Paclitaxel
- Keywords
- BBI608, thymic cancer
- Medical subject headings
- Neoplasms, Thymus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI608Drug
Also called Napabucasin, BB608, BBI-608
PaclitaxelDrug
Also called Abraxane
| Study group | Role | What they receive |
|---|---|---|
| BBI608 and Paclitaxel 200mg BID | Experimental | Patients will receive BBI608 orally continuously at 200mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. Receives: Drug: BBI608; Drug: Paclitaxel |
| BBI608 and Paclitaxel 240mg BID | Experimental | Patients will receive BBI608 orally continuously at 240mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. Receives: Drug: BBI608; Drug: Paclitaxel |
| BBI608 and Paclitaxel 400mg BID | Experimental | Patients will receive BBI608 orally continuously at 400mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. Receives: Drug: BBI608; Drug: Paclitaxel |
| BBI608 and Paclitaxel 480mg BID | Experimental | Patients will receive BBI608 orally continuously at 480mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. Receives: Drug: BBI608; Drug: Paclitaxel |
| BBI608 and Paclitaxel 500mg BID | Experimental | Patients will receive BBI608 orally continuously at 500mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. Receives: Drug: BBI608; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events and Serious Adverse Events
Assessment of safety of napabucasin administered in participants with advanced malignancies for whom weekly paclitaxel was an acceptable option by reporting of adverse events and serious adverse events
Measured: The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.
Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)
Determination of the Recommended Phase 2 dose (RP2D) of napabucasin when administered with paclitaxel in patients with advanced malignancies.
Measured: 28 days
Secondary outcomes (7)
Determination of the Maximum Observed Concentration (Cmax) and Area Under the Plasma Concentration vs. Time Curve (AUClast)
To determine the maximum concentration of napabucasin and the area under the plasma concentration vs. time curve of napabucasin when administered in combination with weekly paclitaxel
Measured: Blood samples drawn on days 16 and 17 of the first study cycle
Preliminary Anti-tumor Activity of BBI608 When Administered in Combination With Paclitaxel in Patients With Advanced Malignancies
To assess the preliminary anti-tumor activity, specifically the objective response rate (ORR) of napabucasin administered in combination with paclitaxel. The Objective Response Rate (ORR) is the proportion of participants with a complete response or partial response who have measurable disease at baseline imaging.
Measured: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, for an anticipated average of six months
The Objective Response Rate of Napabucasin Administered in Combination With Paclitaxel in Patients With Advanced Malignancies
Assessment of the objective response rate (ORR) of napabucasin administered in combination with paclitaxel in patients with advanced malignancies.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; The Objective Response Rate (ORR) is the proportion of participants with a complete response or partial response.
Measured: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 60 months
Disease Control Rate
To determine the disease control rate (CDR) of napabucasin administered in combination with paclitaxel in patients with advanced malignancies.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. The Disease Control Rate (DCR) is the proportion of patients whose best overall response is CR, PR or SD.
Measured: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 60 months.
Progression Free Survival of Patients With Advanced Malignancies
The effect of napabucasin given in combination with paclitaxel on Progression Free Survival (PFS) of patients with advanced malignancies.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 60 months
Overall Survival of Patients With Advanced Malignancies
The effect of napabucasin given in combination with paclitaxel on Overall Survival (OS) of patients with advanced malignancies
Measured: 4 weeks after the patient has been off study treatment, every 3 months up to 18 months, then every 6 months thereafter until death, up to 118 months
Pharmacodynamics
To determine the response (increase or decrease) of biomarkers from biopsied tumors following the administration of napabucasin
Measured: Day 17 of cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startApr 2011
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Lebedinsky, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325441
- Sponsor's protocol ID
- BBI608-201
- Status last verified
- Nov 2023
- First submitted
- 25 Mar 2011
- Last updated
- 15 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01325441
- Acronym / sponsor ID
- BBI608-201
- Conditions
- Cancer
- Keywords
- BBI608, thymic cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 565 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 3 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced malignancies.
Detailed description
This is an open label, multi-center, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced solid tumors for whom weekly paclitaxel is an acceptable option.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BBI608 and Paclitaxel 200mg BID | Experimental | Drug: BBI608, Drug: PaclitaxelPatients will receive BBI608 orally continuously at 200mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. |
| BBI608 and Paclitaxel 240mg BID | Experimental | Drug: BBI608, Drug: PaclitaxelPatients will receive BBI608 orally continuously at 240mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. |
| BBI608 and Paclitaxel 400mg BID | Experimental | Drug: BBI608, Drug: PaclitaxelPatients will receive BBI608 orally continuously at 400mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. |
| BBI608 and Paclitaxel 480mg BID | Experimental | Drug: BBI608, Drug: PaclitaxelPatients will receive BBI608 orally continuously at 480mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. |
| BBI608 and Paclitaxel 500mg BID | Experimental | Drug: BBI608, Drug: PaclitaxelPatients will receive BBI608 orally continuously at 500mg BID. A treatment cycle will be 4 weeks (28 days). BBI608 will be administered twice daily. On days 3, 10, and 17 of each 28 day cycle, patients will receive a 1 hour infusion of paclitaxel. Cycles will be repeated until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, adjustment is permitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
- A histologically or cytologically confirmed ovarian, breast, non-small cell lung, melanoma, gastric/GEJ/esophageal or other type of advanced cancer that is metastatic, unresectable, or recurrent and for which weekly paclitaxel is an acceptable therapeutic option.
- Patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer must also meet the following criteria: a. Must be either platinum-resistant or platinum-refractory according to the following definitions:(1)Platinum-resistant: a response to platinum therapy followed by progression within 6 months after completing therapy (2)Platinum-refractory: best response of stable disease or progression during platinum therapy; b. Must have had prior systemic treatment with a taxane; c. Must have received no more than 4 prior systemic cytotoxic regimens
- Patients with melanoma must also meet the following criteria: a. If melanoma is BRAF wild-type or has BRAF mutations that are not amenable to BRAF inhibitor therapy, and the patient is a candidate for immunotherapy, must have received ipilimumab; b. If melanoma is positive for the V600E or V600K BRAF mutation, must have received at least one line of prior therapy with a BRAF-specific inhibitor; either alone or in combination.
- Patients with triple negative breast cancer (estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), and human epidermal growth factor receptor 2-negative (Her2-) must also meet the following criteria: a. Must have received at least one prior chemotherapy regimen for locally advanced or metastatic disease; b. Must have received prior taxane therapy.
Key exclusion criteria (9 listed)
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose provided all treatment-related adverse events have resolved or have been deemed irreversible, with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 7 days before beginning the administration of BBI608.
- Surgery within 4 weeks prior to first dose
- Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated
- Pregnant or breastfeeding
- Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
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 |
|---|---|---|
| BBI608Also: Napabucasin, BB608, BBI-608 | Drug | BBI608 and Paclitaxel 200mg BID, BBI608 and Paclitaxel 240mg BID, BBI608 and Paclitaxel 400mg BID, BBI608 and Paclitaxel 480mg BID, BBI608 and Paclitaxel 500mg BID |
| PaclitaxelAlso: Abraxane | Drug | BBI608 and Paclitaxel 200mg BID, BBI608 and Paclitaxel 240mg BID, BBI608 and Paclitaxel 400mg BID, BBI608 and Paclitaxel 480mg BID, BBI608 and Paclitaxel 500mg BID |
Primary outcome
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.
Assessment of safety of napabucasin administered in participants with advanced malignancies for whom weekly paclitaxel was an acceptable option by reporting of adverse events and serious adverse events
Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs)
Time frame: 28 days
Determination of the Recommended Phase 2 dose (RP2D) of napabucasin when administered with paclitaxel in patients with advanced malignancies.
7 secondary outcomes
Determination of the Maximum Observed Concentration (Cmax) and Area Under the Plasma Concentration vs. Time Curve (AUClast)
Time frame: Blood samples drawn on days 16 and 17 of the first study cycle
Preliminary Anti-tumor Activity of BBI608 When Administered in Combination With Paclitaxel in Patients With Advanced Malignancies
Time frame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, for an anticipated average of six months
The Objective Response Rate of Napabucasin Administered in Combination With Paclitaxel in Patients With Advanced Malignancies
Time frame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 60 months
Disease Control Rate
Time frame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 60 months.
Progression Free Survival of Patients With Advanced Malignancies
Time frame: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 60 months
Overall Survival of Patients With Advanced Malignancies
Time frame: 4 weeks after the patient has been off study treatment, every 3 months up to 18 months, then every 6 months thereafter until death, up to 118 months
Pharmacodynamics
Time frame: Day 17 of cycle 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Claudia Lebedinsky, MD study director
Sumitomo Pharma America, Inc.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BBI608 and Paclitaxel in people with Cancer, run by Sumitomo Pharma America, Inc. at 22 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 20 inclusion and 9 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 3 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events and Serious Adverse Events (time frame: The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.). The study lists 2 primary outcomes in all. 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 15 Nov 2023.