Non Small Cell Lung Cancer (NSCLC)Phase 1/2NCT01204099
Study of PX-866 and Docetaxel in Solid Tumors
A Phase 1/2 study testing Docetaxel and PX-866 in people with Non Small Cell Lung Cancer (NSCLC) and Squamous Cell Carcinoma of the Head and Neck (SCCHN), run by Cascadian Therapeutics Inc. at 33 sites in 2 countries.
Trial summary
Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- What is being tested?
- Docetaxel and PX-866
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Sep 2010to Feb 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years at time of consent
- Agrees to use a medically accepted form of contraception from the time of consent to completion of all follow up study visits
- If female of child bearing potential, negative pregnancy test (not required for post menopausal females)
- Signed an informed consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC)
- Has either locally advanced, recurrent, or metastatic NSCLC for which they have received at least 1 and no more than 2 prior systemic treatment regimens that may include up to 1 platinum based chemotherapy regimen and/or an epidermal growth factor receptor (EGFR) inhibitor OR locally advanced, recurrent or metastatic SCCHN for which they have received at least one and no more than two prior systemic treatment regimens.
- Measurable disease per Response Evaluation Criteria In Solid Tumors
Show all 16Show fewer
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- In the opinion of the clinical investigator, life expectancy >3 months
- Adequate hematologic function as defined by:
- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count (ANC) ≥1500 cells/µL
- Platelets ≥100,000/µL
- Adequate hepatic function as defined by the following:
- Bilirubin ≤ ULN
- Aspartate aminotransaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤1.5 x upper limit of normal (ULN)
- Creatinine level ≤1.5 x ULN
Who cannot join
- Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- Is breastfeeding
- Treatment with any systemic chemotherapy, epidermal growth factor receptor (EGFR) inhibitor, radiation or experimental agent within 4 weeks of study drug dosing. Washout period following palliative radiation should be discussed with the study medical monitor
- Previous treatment with docetaxel except for patients in Phase 2 who received a docetaxel containing regimen as part of adjuvant or neoadjuvant therapy which was completed at least 6 months prior to study drug dosing
- Previous treatment with a phosphatidylinositol 3 kinase (PI 3K) inhibitor
- Known human immunodeficiency virus (HIV)
Show all 10Show fewer
- Known or suspected clinically active brain metastases. Previously treated and stable brain metastases are allowable. Stable brain metastases are defined as no change on CT scan or MRI for minimum of two months AND no change in steroid dose for a minimum of four weeks, unless change due to intercurrent infection or other acute event
- Grade >2 peripheral neuropathy, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.02
- Any other significant medical or psychiatric condition that in the opinion of the investigator renders the patient inadequate for participation
- History of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States29 sites
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131
University of Colorado Cancer Center
Aurora, Colorado, 80045
Texas Oncology - South Austin
Austin, Texas, 78745
John Hopkins University
Baltimore, Maryland, 21231
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Roswell Park Cancer Institute
Buffalo, New York, 14263
Medical University of South Carolina
Charleston, South Carolina, 29425
Oncology and Hematology Associates of SW Virginia, DBA Blue Ridge Cancer Care
Christiansburg, Virginia, 24073
Mary Crowley Cancer Center
Dallas, Texas, 75201
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Eastern Colorado Health Care System - Denver VA
Denver, Colorado, 80220
Southwest Cancer Care
Escondido, California, 92025
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Cancer Center of Pasco-Pinellas
Holiday, Florida, 34619
Columbia Basin Hematology & Oncology
Kennewick, Washington, 99336
New York Oncology, Hematology
Latham, New York, 12110
Beth Israel Hospital
New York, New York, 10003
New York University Medical Center
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
Virginia Oncology Associates
Newport News, Virginia, 23606
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523
Medical Oncology Associates
Spokane, Washington, 99208
Washington University
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
Northwest Cancer Specialists
Tualatin, Oregon, 97062
Cancer Center of Kansas
Wichita, Kansas, 67214
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
Canada4 sites
London Regional Cancer Program
London, Ontario, N6A 4L6
Jewish General Hospital
Montreal, Quebec, H3T1E2
CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors
Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors.
Phase 2: To determine the antitumor activity and safety of PX-866 in combination with docetaxel versus docetaxel alone in patients with NSCLC or SCCHN.
Read the detailed description
This is a Phase 1/2 open-label study. In the Phase 1 part of the study, PX-866 was given in combination with docetaxel to patients with incurable locally advanced, recurrent or metastatic cancer.
Phase 2 of the study is an open-label, randomized evaluation of the antitumor activity and safety of PX-866, administered at the MTD/RD identified in Phase 1 (8mg daily), in combination with docetaxel versus docetaxel alone in patients with locally advanced, recurrent, or metastatic NSCLC (Group 1) or patients with locally advanced, recurrent, or metastatic SCCHN (Group 2).
Group 1 (patients with locally advanced, recurrent, or metastatic NSCLC) is now closed to enrollment.
All treatments will be administered on a 21-day cycle. Docetaxel 75 mg/m2 will be administered IV on Day 1 of each 21-day cycle. PX-866 will be administered orally or via PEG tube (if applicable) once per day on Days 1 to 21 of all treatment cycles in patients randomized to the treatment arm containing PX-866.
Patients will be evaluated for progression approximately every 6 weeks. Patients with stable disease (SD) or better, per investigator assessment, will receive repeat cycles of treatment on a 21-day schedule until disease progression, unacceptable toxicity or withdrawal of consent.
- Being tested
- Docetaxel, PX-866
- Keywords
- PX-866, Non small cell lung cancer, solid tumors, Squamous cell cancer of the head and neck, docetaxel, NSCLC, taxotere, SCCHN, PI-3K, PI3 kinase, PI3K
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called taxotere
PX-866Drug
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel (NSCLC) | Active comparator | IV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent. Receives: Drug: Docetaxel |
| PX-866 (NSCLC) | Experimental | Oral PX-866 administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent. Receives: Drug: Docetaxel; Drug: PX-866 |
| Docetaxel (SCCHN) | Active comparator | IV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent. Receives: Drug: Docetaxel |
| PX-866 (SCCHN) | Experimental | Oral PX-866, administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent. Receives: Drug: Docetaxel; Drug: PX-866 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 42 days
Secondary outcomes (3)
Objective response rate (ORR)
Measured: 42 days
Incidence and severity of adverse events
Measured: 42 days
Overall survival
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer (NSCLC)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cascadian Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204099
- Sponsor's protocol ID
- PX-866-002
- Status last verified
- Apr 2015
- First submitted
- 15 Sep 2010
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01204099
- Acronym / sponsor ID
- PX-866-002
- Keywords
- PX-866, Non small cell lung cancer, solid tumors, Squamous cell cancer of the head and neck, docetaxel, NSCLC, taxotere, SCCHN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Cascadian Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Sep 2010 (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.
Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors.
Phase 2: To determine the antitumor activity and safety of PX-866 in combination with docetaxel versus docetaxel alone in patients with NSCLC or SCCHN.
Detailed description
This is a Phase 1/2 open-label study. In the Phase 1 part of the study, PX-866 was given in combination with docetaxel to patients with incurable locally advanced, recurrent or metastatic cancer.
Phase 2 of the study is an open-label, randomized evaluation of the antitumor activity and safety of PX-866, administered at the MTD/RD identified in Phase 1 (8mg daily), in combination with docetaxel versus docetaxel alone in patients with locally advanced, recurrent, or metastatic NSCLC (Group 1) or patients with locally advanced, recurrent, or metastatic SCCHN (Group 2).
Group 1 (patients with locally advanced, recurrent, or metastatic NSCLC) is now closed to enrollment.
All treatments will be administered on a 21-day cycle. Docetaxel 75 mg/m2 will be administered IV on Day 1 of each 21-day cycle. PX-866 will be administered orally or via PEG tube (if applicable) once per day on Days 1 to 21 of all treatment cycles in patients randomized to the treatment arm containing PX-866.
Patients will be evaluated for progression approximately every 6 weeks. Patients with stable disease (SD) or better, per investigator assessment, will receive repeat cycles of treatment on a 21-day schedule until disease progression, unacceptable toxicity or withdrawal of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Docetaxel (NSCLC) | Active comparator | Drug: DocetaxelIV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent. |
| PX-866 (NSCLC) | Experimental | Drug: Docetaxel, Drug: PX-866Oral PX-866 administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent. |
| Docetaxel (SCCHN) | Active comparator | Drug: DocetaxelIV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent. |
| PX-866 (SCCHN) | Experimental | Drug: Docetaxel, Drug: PX-866Oral PX-866, administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At least 18 years at time of consent
- Agrees to use a medically accepted form of contraception from the time of consent to completion of all follow up study visits
- If female of child bearing potential, negative pregnancy test (not required for post menopausal females)
- Signed an informed consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC)
- Has either locally advanced, recurrent, or metastatic NSCLC for which they have received at least 1 and no more than 2 prior systemic treatment regimens that may include up to 1 platinum based chemotherapy regimen and/or an epidermal growth factor receptor (EGFR) inhibitor OR locally advanced, recurrent or metastatic SCCHN for which they have received at least one and no more than two prior systemic treatment regimens.
Key exclusion criteria (10 listed)
- Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- Is breastfeeding
- Treatment with any systemic chemotherapy, epidermal growth factor receptor (EGFR) inhibitor, radiation or experimental agent within 4 weeks of study drug dosing. Washout period following palliative radiation should be discussed with the study medical monitor
- Previous treatment with docetaxel except for patients in Phase 2 who received a docetaxel containing regimen as part of adjuvant or neoadjuvant therapy which was completed at least 6 months prior to study drug dosing
- Previous treatment with a phosphatidylinositol 3 kinase (PI 3K) inhibitor
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 |
|---|---|---|
| DocetaxelAlso: taxotere | Drug | Docetaxel (NSCLC), Docetaxel (SCCHN), PX-866 (NSCLC), PX-866 (SCCHN) |
| PX-866 | Drug | PX-866 (NSCLC), PX-866 (SCCHN) |
Primary outcome
Progression Free Survival
Time frame: 42 days
3 secondary outcomes
Objective response rate (ORR)
Time frame: 42 days
Incidence and severity of adverse events
Time frame: 42 days
Overall survival
Time frame: 42 days
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 16 May 2018.
Related trials for Non Small Cell Lung Cancer (NSCLC)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 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 Docetaxel and PX-866 in people with Non Small Cell Lung Cancer (NSCLC) and Squamous Cell Carcinoma of the Head and Neck (SCCHN), run by Cascadian Therapeutics Inc. at 33 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 16 inclusion and 10 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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?
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: 42 days). 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 16 May 2018.