Solid TumorsPhase 1NCT01525602

Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors

A Phase 1 study testing PLX3397 and Paclitaxel in people with Solid Tumors, run by Daiichi Sankyo at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors
What is being tested?: PLX3397 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: 74 participants
Where: 8 sitesUnited States
Study dates: May 2012to Feb 2018
Phase: Phase 1
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

Patients with:
Part 1 (enrollment closed): an advanced, incurable solid tumor
Part 2 (enrollment closed): an advanced, incurable solid tumor for whom a taxane would be considered a reasonable chemotherapy option
Part 3 (enrollment closed): advanced, metastatic or non-resectable epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer with
platinum-resistant cancer, defined as disease that responded to a platinum-containing chemotherapy regimen, but demonstrated recurrence within six months following the completion of that platinum-containing regimen, OR
platinum-refractory cancer, defined as disease failed to achieve at least a partial response to a platinum-containing regimen (i.e., stable disease or actual disease progression), AND

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have not been treated with a taxane within six months of Cycle 1 Day 1 (C1D1), AND
have not been treated with weekly paclitaxel after first-line treatment in which weekly paclitaxel plus a platinum is permitted
Part 3: Patients must have target (≥2 cm diameter) or non-target lesion cancer that is accessible for core biopsies before starting on study and after one cycle of treatment.
Patients with stable brain metastases are eligible for this trial. However, patients must not have required steroid treatment for their brain metastases within 30 days of Screening.
Bone-directed therapy (e.g., bisphosphonates or denosumab) is permitted.
Washout from any prior investigational therapy of at least five times the T1/2 prior to C1D1
Washout from any prior biologic or targeted therapy at least 4 weeks or five times the plasma half-life (T1/2) (whichever is shorter) prior to C1D1
Washout from prior chemotherapy of at least 2 weeks or 1 elimination half-life, whichever is longer, prior to C1D1
Washout from prior hormonal therapy of at least 2 weeks prior to C1D1
Washout of at least 2 weeks from the most recent radiation treatment prior to C1D1
Resolution of all prior treatment-related toxicities to Grade 1 or less, except for Grade 2 fatigue or alopecia prior to C1D1
Age eighteen years or older
Eastern Cooperative Oncology Group (ECOG) performance status 0-2, inclusive
Anticipated life expectancy of at least 12 weeks
Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥1500/mm3, platelets ≥100,000/mm3
Adequate renal function: serum creatinine <1.5 x ULN or calculated creatinine clearance (CrCl) >60 mL/min using Cockcroft-Gault formula
Adequate hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN), Total and Direct Bilirubin <1.5 x ULN. However, in the presence of liver metastases, AST and ALT must be <5 x ULN
Cardiac ejection fraction ≥50%, and QT interval corrected by Fridericia's formula (QTcF) <450 ms (males) or <470 ms (females) on electrocardiogram (ECG) at Baseline.
Able to swallow capsules and maintain adequate hydration
Ability to give written informed consent and willing to comply with the requirements of the protocol; and for Part 3, to give written informed consent for 2 cancer biopsy procedures
Women of child-bearing potential must agree to use an effective method of birth control during treatment and for three months after receiving their last dose of study drug. Fertile men must also agree to use an acceptable method of birth control while on study drug and for at least 3 months after last dose.

Who cannot join

Presence of an active secondary malignancy.
Patients with a non-melanomatous, in situ malignancy or disease that is completely resectable with surgery may be considered after discussion with the Medical Monitor
Patients with a completely treated prior malignancy with no evidence of disease for ≥3 years are eligible
Refractory nausea and vomiting, malabsorption, external biliary shunt or significant small bowel resection that would preclude adequate absorption of PLX3397
Ongoing treatment with any other investigational therapy
Prior anaphylactic or severe hypersensitivity reaction to paclitaxel or Cremophor-containing agent.

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Persistent grade 2 fatigue at Baseline.
Severe, concurrent illness including congestive heart failure, significant cardiac disease and uncontrolled hypertension, that would likely prevent the patient from being able to comply with the study protocol
Active untreated infection
Known chronic active Hepatitis B or C, or HIV infection
The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Colorado, Anschutz Cancer Pavilion
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43210
Sylvester Comprehensive Cancer Center/UMHC
Miami, Florida, 33136
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Univeristy of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

Official title: A Phase 1b Study to Assess the Safety of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors

This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twice daily (BID) administered in combination with weekly paclitaxel in participants with advanced, metastatic or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Conditions: Solid Tumors
Being tested: PLX3397, Paclitaxel
Keywords: advanced, incurable solid tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PLX3397Drug
Also called Pexidartinib
PLX3397 tablets, 200mg
PaclitaxelDrug
Also called Onxol
Paclitaxel IV

Study groups in NCT01525602
Study group	Role	What they receive
Part 1	Experimental	Open-label, sequential PLX3397 single-agent dose escalation in combination with paclitaxel in approximately 30 patients with advanced solid tumors. Enrollment completed. (Closed to recruitment) Receives: Drug: PLX3397; Drug: Paclitaxel
Part 2	Experimental	Extension cohort at the RP2D of single-agent PLX3397 in combination with paclitaxel in approximately 30 patients in advanced solid tumors. Enrollment completed. (Closed to recruitment) Receives: Drug: PLX3397; Drug: Paclitaxel
Part 3	Experimental	Extension cohort at the RP2D of single-agent PLX3397 in combination with paclitaxel in approximately 30 patients with advanced, metastatic, or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Closed to recruitment) Receives: Drug: PLX3397; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population)
Treatment-emergent adverse events (TEAEs) reported by >10% of all participants in Parts 1 and 2 are reported.
Measured: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population)
Treatment-emergent adverse events (TEAEs) reported by >10% of all participants in Part 3 are reported.
Measured: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population)
Best overall tumor response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From post first dose up to 5 years 9 months post dose
Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)
Best overall tumor response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From 26 days (CR and PR) and 54 days (SD) up to 5 years 9 months post dose

Secondary outcomes (9)

Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population)
Measured: From the date of initial response until disease progression or death, whichever occurs first, up to 5 years 9 months post dose
Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)
Measured: From the date of initial response until disease progression or death, whichever occurs first, up to 5 years 9 months post dose
Progression-free Survival Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)
Progression-free survival (PFS) is defined as the number of days from the start of therapy (i.e. Cycle 1 Day 1) to the date of first documented disease progression/relapse or death, whichever occurs first. If the disease progression/relapse does not occur, PFS will be censored as of the date of their last evaluable tumor assessments.
Measured: From the first day of treatment to the first documented disease progression or date of death, whichever occurred first, up to 5 years 9 months post dose
A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3)
Measured: Cycle 1, Day 15
A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3)
Measured: Cycle 1, Day 15
A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3)
Measured: Cycle 1, Day 15
Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set)
Measured: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set)
Measured: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set)
Measured: From post first dose up to 28 days after the last dose, up to 5 years 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Feb 2018

First posted3 Feb 2012 (estimated)
Study startMay 2012
Primary completionDec 2017
Study completionFeb 2018

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 Solid TumorsStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01525602
Sponsor's protocol ID: PLX108-07
Status last verified: Jul 2020
First submitted: 31 Jan 2012
Last updated: 16 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b Study to Assess the Safety of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT01525602
Acronym / sponsor ID: PLX108-07
Conditions: Solid Tumors
Keywords: advanced, incurable solid tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Collaborators: Plexxikon
Study start: May 2012
Primary completion: Dec 2017 (actual)
Study completion: Feb 2018 (actual)
First posted: 3 Feb 2012 (estimated)
Results: Posted 16 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Part 1	Experimental	Drug: PLX3397, Drug: PaclitaxelOpen-label, sequential PLX3397 single-agent dose escalation in combination with paclitaxel in approximately 30 patients with advanced solid tumors. Enrollment completed. (Closed to recruitment)
Part 2	Experimental	Drug: PLX3397, Drug: PaclitaxelExtension cohort at the RP2D of single-agent PLX3397 in combination with paclitaxel in approximately 30 patients in advanced solid tumors. Enrollment completed. (Closed to recruitment)
Part 3	Experimental	Drug: PLX3397, Drug: PaclitaxelExtension cohort at the RP2D of single-agent PLX3397 in combination with paclitaxel in approximately 30 patients with advanced, metastatic, or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Closed to recruitment)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

Patients with:
Part 3: Patients must have target (≥2 cm diameter) or non-target lesion cancer that is accessible for core biopsies before starting on study and after one cycle of treatment.
Patients with stable brain metastases are eligible for this trial. However, patients must not have required steroid treatment for their brain metastases within 30 days of Screening.
Bone-directed therapy (e.g., bisphosphonates or denosumab) is permitted.
Washout from any prior investigational therapy of at least five times the T1/2 prior to C1D1

Key exclusion criteria (11 listed)

Presence of an active secondary malignancy.
Refractory nausea and vomiting, malabsorption, external biliary shunt or significant small bowel resection that would preclude adequate absorption of PLX3397
Ongoing treatment with any other investigational therapy
Prior anaphylactic or severe hypersensitivity reaction to paclitaxel or Cremophor-containing agent.
Persistent grade 2 fatigue at Baseline.

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
PLX3397Also: PexidartinibPLX3397 tablets, 200mg	Drug	Part 1, Part 2, Part 3
PaclitaxelAlso: OnxolPaclitaxel IV	Drug	Part 1, Part 2, Part 3

Primary outcome

Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population)
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Treatment-emergent adverse events (TEAEs) reported by >10% of all participants in Parts 1 and 2 are reported.
Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population)
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Treatment-emergent adverse events (TEAEs) reported by >10% of all participants in Part 3 are reported.
Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population)
Time frame: From post first dose up to 5 years 9 months post dose
Best overall tumor response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)
Time frame: From 26 days (CR and PR) and 54 days (SD) up to 5 years 9 months post dose
Best overall tumor response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

9 secondary outcomes

Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population)
Time frame: From the date of initial response until disease progression or death, whichever occurs first, up to 5 years 9 months post dose
Duration of Response Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)
Time frame: From the date of initial response until disease progression or death, whichever occurs first, up to 5 years 9 months post dose
Progression-free Survival Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)
Time frame: From the first day of treatment to the first documented disease progression or date of death, whichever occurred first, up to 5 years 9 months post dose
A Summary of Pharmacokinetic Parameter (Tmax) Following Exposure to PLX3397 (Parts 1 and 3)
Time frame: Cycle 1, Day 15
A Summary of Pharmacokinetic Parameter (Cmax) Following Exposure to PLX3397 (Parts 1 and 3)
Time frame: Cycle 1, Day 15
A Summary of Pharmacokinetic Parameters (AUC[0-4h], AUC[0-6h], and AUC[0-12h]) Following Exposure to PLX3397 (Parts 1 and 3)
Time frame: Cycle 1, Day 15
Percentage of Participants With PLX3397-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set)
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Percentage of Participants With Paclitaxel-Related Treatment-emergent Adverse Events (>10%) by Preferred Term (Parts 1 and 2) (Safety Analysis Set)
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months
Percentage of Participants With PLX3397- and/or Paclitaxel-Related TEAEs (>10%) by Preferred Term (Part 3) (Safety Analysis Set)
Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months

Results and safety

Results posted to the registry on 16 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Cohort 1; 600 mg/Day	9	0
Part 1: Cohort 2; 800 mg/Day	3	0
Part 1: Cohort 3; 1000 mg/Day	3	0
Part 1: Cohort 4; 1200 mg/Day	6	0
Part 1 and 2: Cohort 5; 1600 mg/Day	33	0
Part 3: PLX3397 600 mg BID	7	0
Part 3: Paclitaxel 80 mg/m^2	6	0
Part 3: PLX3397 600 mg + Paclitaxel 80 mg/m^2	7	0

Primary outcome: Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population)

Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months. Number. Unit: percentage of participants

Measure	Part 1: Cohort 1; 600 mg/Day n = 9	Part 1: Cohort 2; 800 mg/Day n = 3	Part 1: Cohort 3; 1000 mg/Day n = 3	Part 1: Cohort 4; 1200 mg/Day n = 6	Part 1 and 2: Cohort 5; 1600 mg/Day n = 33
Any TEAE	100	100	100	100	100
Gastrointestinal disorders	89	67	100	83	91
Nausea	44	33	67	67	42
Diarrhea	33	33	67	50	39
Vomiting	33	0	33	33	36
Constipation	33	0	33	0	21
General disorders/administrative site conditions	89	100	67	100	79
Fatigue	78	100	33	83	70

Population analysed: Safety events were assessed in the Safety Population.

Primary outcome: Percentage of Participants With TEAEs (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Safety Population)

Time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months. Number. Unit: percentage of participants

Measure	Part 3: PLX3397 600 mg BID n = 7	Part 3: Paclitaxel 80 mg/m^2 n = 5	Part 3: PLX3397 600 mg + Paclitaxel 80 mg/m^2 n = 6
Any TEAE	100	100	100
Gastrointestinal disorders	100	100	83.3
Nausea	71.4	60	66.7
Diarrhea	57.1	40	50
Constipation	28.6	60	16.7
Vomiting	14.3	40	50
Abdominal distension	14.3	40	16.7
Abdominal pain	28.6	20	16.7

Population analysed: Safety events were assessed in the Safety Population.

Primary outcome: Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Efficacy Evaluable Population)

Time frame: From post first dose up to 5 years 9 months post dose. Number. Unit: percentage of participants

Measure	Part 1: Cohort 1; 600 mg/Day n = 6	Part 1: Cohort 2; 800 mg/Day n = 3	Part 1: Cohort 3; 1000 mg/Day n = 3	Part 1: Cohort 4; 1200 mg/Day n = 6	Part 1 and 2: Cohort 5; 1600 mg/Day n = 20
Complete response (CR)	0	0	0	0	5
Partial response (PR)	17	0	33	17	10
Stable disease	33	33	33	50	30
Progressive disease	50	67	33	33	45
Unable to assess	0	0	0	0	10
Best overall response rate (CR or PR)	17	0	33	17	15
Clinical benefit rate (CR, PR, or stable disease)	50	33	67	67	45

Population analysed: Best overall tumor response was assessed in the Efficacy Evaluable Population.

Primary outcome: Best Overall Tumor Response Based on RECIST V1.1 Following PLX3397 Administered in Combination With Paclitaxel (Part 3) (Efficacy Evaluable Population)

Time frame: From 26 days (CR and PR) and 54 days (SD) up to 5 years 9 months post dose. Number. Unit: percentage of participants

Measure	Part 3: PLX3397 600 mg BID n = 4	Part 3: Paclitaxel 80 mg/m^2 n = 5	Part 3: PLX3397 600 mg BID + Paclitaxel 80 mg/m^2 n = 5
Complete response (CR)	0	0	0
Partial response (PR)	0	40	20
Stable disease (SD)	50	0	20
Progressive disease (PD)	50	60	60
Best overall response rate (CR or PR)	0	40	20
Clinical benefit rate (CR, PR, or stable disease)	50	40	40

Population analysed: Best overall tumor response was assessed in the Efficacy Evaluable Population.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and serious adverse events were recorded from the time the patient received the first dose of study drug up to 28 days after the last dose or before the start of a new anti-tumor therapy, whichever occurred first, up to 5 years 9 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Cohort 1; 600 mg/Day	1 of 9 (11.1%)	9 of 9 (100%)	1 of 9
Part 1: Cohort 2; 800 mg/Day	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part 1: Cohort 3; 1000 mg/Day	3 of 3 (100%)	3 of 3 (100%)	1 of 3
Part 1: Cohort 4; 1200 mg/Day	2 of 6 (33.3%)	6 of 6 (100%)	1 of 6
Part 1 and 2: Cohort 5; 1600 mg/Day	10 of 33 (30.3%)	33 of 33 (100%)	5 of 33
Part 3: PLX3397 600 mg BID	5 of 7 (71.4%)	7 of 7 (100%)	1 of 7
Part 3: Paclitaxel 80 mg/m^2	2 of 5 (40%)	5 of 5 (100%)	1 of 6
Part 3: PLX3397 600 mg BID + Paclitaxel 80 mg/m^2	3 of 6 (50%)	6 of 6 (100%)	1 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

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Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

8 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 PLX3397 and Paclitaxel in people with Solid Tumors, run by Daiichi Sankyo at 8 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 27 inclusion and 11 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 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Yes. Results are posted in the registry (first posted 16 Jul 2020). 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?

Percentage of Participants With Treatment-emergent Adverse Events (>10%) Classified by Preferred Term Following PLX3397 Administered in Combination With Paclitaxel (Parts 1 and 2) (Safety Population) (time frame: From post first dose up to 28 days after the last dose, up to 5 years 9 months). The study lists 4 primary outcomes in all. 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 NCT01525602.

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 16 Jul 2020.