CarcinomaPhase 1/2NCT03221400
PEN-866 in Patients With Advanced Solid Malignancies
A Phase 1/2 study testing PEN-866 Sodium, fluorouracil and Folinic acid in people with Carcinoma and Endometrial Adenocarcinoma, run by Tarveda Therapeutics at 16 sites in United States.
Trial summary
Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Endometrial Adenocarcinoma, Neoplasms
- What is being tested?
- PEN-866 Sodium, fluorouracil and Folinic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 16 sitesUnited States
- Study dates
- 29 Aug 2017to Jun 2023
- 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
- M/F at least 18 years old
- Performance status 0 or 1
- Adequate bone marrow, liver, and kidney function within 28 days prior to first dose
- Serum potassium, calcium, magnesium, phosphorus within normal limits
- Adequate birth control
- Central venous access line is required
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- Patients in Phase 1a must also have confirmed advanced solid malignancy that has progressed after one or more prior lines of anticancer therapy and no other standard of care therapies that are deemed appropriate for treatment of their malignancy
- Patients in Phase 2a must have measurable disease per RECIST 1.1 and documented disease progression during or after their most recent line of anticancer therapy.
- Patients in Phase 2a must have disease history specific to their disease as listed below:
- Small Cell Lung Cancer (SCLC): Patients with locally recurrent or metastatic SCLC whose disease has progressed after having received one or more prior lines of chemotherapy.
- Gastric or gastroesophageal (GEJ) adenocarcinoma: Patients with locally recurrent or metastatic gastric or GEJ adenocarcinoma whose disease has progressed after having received one or more prior lines of chemotherapy.
- Squamous cell carcinoma (SCC) of the genitalia (anus, cervix, vulva, or penis): Patients with locally recurrent or metastatic SCC of the genitalia (anus, cervix, vulva, or penis) whose disease has progressed after having received one or more prior lines of chemotherapy, including those whose disease has progressed after postoperative adjuvant chemotherapy or neoadjuvant chemotherapy prior to radiation or surgery.
- Pancreatic adenocarcinoma (PDAC): Patients with locally recurrent or metastatic PDAC whose disease has progressed after having received one or more prior lines of chemotherapy, including those whose disease has progressed within 6 months of postoperative adjuvant chemotherapy.
- Endometrial adenocarcinoma (EC): Patients with locally recurrent or metastatic EC whose disease has progressed after having received one or more prior lines of chemotherapy, including those whose disease has progressed within 6 months of postoperative adjuvant chemotherapy.
- For Phase 1b patients receiving PEN-866 in combination with fluorouracil and folinic acid only:
- Patients with metastatic PDAC who have progressed after having received one or more prior lines of chemotherapy, including those whose disease has progressed within 6 months of postoperative adjuvant chemotherapy.
- For Phase 1b patients receiving the Niraparib combination only:
- Patients must have confirmed advanced solid malignancy that has progressed after one or more prior lines of anticancer therapy and no other standard of care therapies that are deemed appropriate for treatment of their malignancy
Who cannot join
- Treatment with anticancer therapy or investigational drug or device within 2 wk (6 wk for nitrosureas or mitomycin C) before C1D1, and any drug-related toxicities must have recovered to grade 1 or less with the exception of alopecia and peripheral neuropathy.
- Phase 2a only: Prior treatment with topoisomerase I inhibitor(s).
- Cardiac disease such as unstable angina within 6 months of screening, myocardial infarction within 6 months of screening, NY Heart Association Class III - IV heart failure, QTc greater than 470 msec, congenital long Qt syndrome, symptomatic orthostatic hypotension within 6 months of screening, uncontrolled hypertension, or clinically important abnormalities in heart rhythm, conduction, morphology of resting ECG.
- -For Phase 1b patients receiving the Niraparib combination only: hypertension as defined as diastolic > 90 mmHg or systolic > 140 mmHg
- Stroke or transient ischemic attack within 6 months of screening
- Prior history of posterior reversible excephalopathy scyndrome (PRES).
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- Peripheral neuropathy greater than grade 2
- Patients requiring medications with drugs that are inhibitors of UGT1A1 or substrates of CYP1A2, P-gP, BCRP, OATP1B1, OATP1B3 or OCT1 transporters
- Leptomeningeal disease or spinal cord compression unless controlled and asymptomatic with surgery, radiation, and not requiring steroids within 4 weeks prior to C1D1.
- Brain metastases unless previously treated and asymptomatic. Stable low dose of steroids is permitted.
- Major surgery within 28 days of first drug dose
- If female, pregnant or breast feeding
- Evidence of severe uncontrolled systemic disease, bleeding diatheses, renal or liver transplant, active infection with hep B or C or HIV
- Hypersensitivity or anaphylactic reaction to ganetespib or other HSP90 inhibitors, irinotecan, SN-38 or its derivatives
- Any medical, psychological, or social condition that would interfere with the patient's participation in the study.
- Live virus and bacterial vaccines administered within 30 days prior to C1D1.
- Any medical, psychological, or social condition that would interfere with the patient's participation in the study.
- For Phase 1b patients receiving niraparib combination only, the following additional exclusion criteria apply:
- Prior treatment with niraparib.
- Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastatses or otherwise stable chronic liver disease per investigator assessment).
- Severe hepatic impairment.
- Treatment with transfusions and/or erythropoietin for the treatment of anemia within 4 weeks prior to C1D1.
- Any known or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- History of prostate cancer.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
National Institutes of Health / National Cancer Institute
Bethesda, Maryland, 20892
- Recruiting
Sarah Cannon Reasearch Institute at HealthONE
Denver, Colorado, 80218
- Recruiting
Henry Ford
Detroit, Michigan, 48202
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
- Recruiting
The West Clinic
Germantown, Tennessee, 38138
- Recruiting
Prisma Health - Upstate
Greenville, South Carolina, 29605
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Recruiting
Stephenson Cancer Center, University of Oklahoma
Oklahoma City, Oklahoma, 73104
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
- Recruiting
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
- Recruiting
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705
- Recruiting
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401
About this study
Official title: A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies
Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
Read the detailed description
Phase 1a will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD) of PEN-866 (single agent).
Phase 1b will employ a standard 3 + 3 design to make dose recommendations and estimate the MTD of PEN-866 in combination therapy.
Phase 2a (single agent) will assess the safety, tolerability, pharmacokinetic, and pharmacodynamics profile of PEN-866 (single agent) at the recommended Phase 2 dose determined at the conclusion of Phase 1a in patients with advanced solid malignancies.
- Conditions
- Carcinoma, Endometrial Adenocarcinoma, Neoplasms, Squamous Cell Carcinoma of the Anus, Adenocarcinoma of the Pancreas, Advanced Cancer
- Being tested
- PEN-866 Sodium, fluorouracil, Folinic acid, Niraparib
- Medical subject headings
- Carcinoma, Neoplasms, Anus Neoplasms, Carcinoma, Squamous Cell, Stomach Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEN-866 SodiumDrug
PEN-866 Sodium is a miniaturized conjugate that comprises an HSP90 targeting ligand linked to SN-38, the active metabolite of irinotecan. PEN-866 is available as a sterile lyophilized powder for solution for infusion.
fluorouracilDrug
Also called 5-Fluorouracil, 5-FU
Fluorouracil 2400 mg/m2 IV
Folinic acidDrug
Also called Leucovorin
Folinic acid 400 mg/m2 IV
NiraparibDrug
Also called Zejula
Niraparib
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a PEN-866 Sodium (Single Agent) | Experimental | Dose escalation of PEN-866 Sodium administered intravenously Receives: Drug: PEN-866 Sodium |
| Phase 1b PEN-866 Sodium + Flurouracil + Folinic Acid | Experimental | Dose escalation of intravenous administration of PEN-866 Sodium in combination with fluorouracil and folinic acid Receives: Drug: PEN-866 Sodium; Drug: fluorouracil; Drug: Folinic acid |
| Phase 2a PEN-866 Sodium (Single Agent) | Experimental | Intravenously administered PEN-866 Sodium at the Recommended Phase 2 Dose Receives: Drug: PEN-866 Sodium |
| Phase 1b PEN-866 Sodium + Niraparib | Experimental | Dose escalation of intravenous administration of PEN-866 Sodium in combination with niraparib Receives: Drug: PEN-866 Sodium; Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a and 1b : Incidence of Dose-Limiting Toxicities (DLTs)
The Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) will be determined by assessing the incidence of DLTs and treatment related adverse events of PEN-866 as a single agent (Phase 1a) or in combination therapy (Phase 1b).
Measured: Patients will be followed for 28 days to determine the incidence of DLTs.
All Phases: Incidence of treatment related adverse events (Safety and tolerability)
Safety and tolerability will be determined by assessing the incidence of treatment related adverse events.
Measured: From date of first treatment/trial entry up to 28 days following the last treatment.
Phase 2a: Efficacy of PEN-866 in patients with SCLC using best overall response rate
Efficacy of PEN-866 in patients with SCLC will be assessed using best overall tumor response rate defined as complete response (CR) or partial response (PR) according to RECIST 1.1.
Measured: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Phase 2a: Efficacy of PEN-866 in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma using best overall response rate
Efficacy of PEN-866 in patients with gastric or GEJ adenocarcinoma will be assessed using best overall tumor response rate defined as CR or PR according to RECIST 1.1.
Measured: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Phase 2a: Efficacy of PEN-866 in patients with pancreatic adenocarcinoma using Disease Control Rate (DCR)
Efficacy of PEN-866 in patients with pancreatic adenocarcinoma will be assessed using DCR defined as a best response of CR, PR, or stable disease (SD) according to RECIST 1.1.
Measured: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Phase 2a: Efficacy of PEN-866 in patients with endometrial adenocarcinoma using best overall response rate
Efficacy of PEN-866 in patients with endometrial adenocarcinoma will be assessed using best over all tumor response rate defined as CR or PR according to RECIST 1.1.
Measured: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Phase 2a: Efficacy of PEN-866 in patients with squamous cell carcinoma of the genitalia (anus, cervix, vulva, or penis) using best overall response rate
Efficacy of PEN-866 in patients with squamous cell carcinoma of the genitalia will be assessed using best over all tumor response rate defined as CR or PR according to RECIST 1.1.
Measured: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Secondary outcomes (11)
Maximum concentration (Cmax) of PEN-866 and its components (HSP90 ligand and SN-38)
Characterize the pharmacokinetic properties of PEN-866 and its components (HSP90 targeting ligand and SN-38)
Measured: 1 Month (Phase 1a); 14 days (Phase 1b); assessed up to (estimated) 18 months for Phase 2a
Area under the curve (AUC) of PEN-866 and its components (HSP90 ligand and SN-38)
Characterize the pharmacokinetic properties of PEN-866 and its components (HSP90 targeting ligand and SN-38)
Measured: 1 Month (Phase 1a); 14 days (Phase 1b); assessed up to (estimated) 18 months for Phase 2a
Half-life (t1/2) of PEN-866 and its components (HSP90 ligand and SN-38)
Characterize the pharmacokinetic properties of PEN-866 and its components (HSP90 targeting ligand and SN-38)
Measured: 1 Month (Phase 1a); 14 days (Phase 1b); assessed up to (estimated) 18 months for Phase 2a
Phase 1b: Characterize the plasma pharmacokinetics (PK) of the combination therapies and their components
PK parameters (CMax, AUC) will be evaluated in plasma by standard non-compartmental methods (compartmental modeling may be performed if appropriate).
Measured: 14 days
Phase 1a: Tumor response using RECIST 1.1 criteria
Size of tumors by CT or MRI using tumor response criteria according to RECIST 1.1 and duration of response.
Measured: Baseline and every 6 weeks until date of first documented progression or death (estimated 6 months)
Phase 1b: Disease Control Rate
Efficacy of PEN-866 in combination therapy will be assessed using DCR as defined as CR, PR, or SD according to RECIST 1.1.
Measured: From date of first treatment through the date of date of first documented progression, assessed up to (estimated) 18 months
Phase 2a: Disease Control Rate in patients with SCLC, gastric or gastroesophageal junction adenocarcinoma, endometrial adenocarcinoma, and squamous cell carcinoma of the genitalia (anus, cervix, vulva, and penis)
Efficacy of PEN-866 in SCLC, gastric or gastroesophageal junction adenocarcinoma, endometrial adenocarcinoma, and squamous cell carcinoma of the genitalia (anus, cervix, vulva, and penis) will be assessed using DCR as defined as CR, PR, or SD according to RECIST 1.1.
Measured: From date of first treatment through the date of date of first documented progression, assessed up to (estimated) 18 months
Phase 2a: Evaluate the best overall response rate in patients with pancreatic adenocarcinoma
Efficacy of PEN-866 in pancreatic adenocarcinoma using best overall tumor response rate as defined as CR or PR according to RECIST 1.1
Measured: From date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Phase 1b and 2a: Duration of Response
Time from first documented response (CR or PR) to date of first documented disease progression or death due to underlying cancer.
Measured: From date of first treatment until the date of date of death from any cause, assessed up to (estimated) 18 months
Phase 2a: Radiographic progression free survival
Time from first PEN-866 dose to date of first documented progression or date of death from any cause, whichever came first
Measured: From date of first treatment until the date of first documented progression or date of death from any cause, whichever is first, assessed up to (estimated) 18 months
Phase 2a: Overall survival
Time from first PEN-866 dose to date of death from any cause
Measured: From date of first treatment until the date of date of death from any cause, assessed up to (estimated) 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start29 Aug 2017
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarveda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anish Thomas, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221400
- Sponsor's protocol ID
- PEN-866-001
- Status last verified
- Feb 2022
- First submitted
- 13 Jul 2017
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT03221400
- Acronym / sponsor ID
- PEN-866-001
- Conditions
- Carcinoma, Endometrial Adenocarcinoma, Neoplasms, Squamous Cell Carcinoma of the Anus, Adenocarcinoma of the Pancreas, Advanced Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Tarveda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 18 Jul 2017 (actual)
- 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.
Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
Detailed description
Phase 1a will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD) of PEN-866 (single agent).
Phase 1b will employ a standard 3 + 3 design to make dose recommendations and estimate the MTD of PEN-866 in combination therapy.
Phase 2a (single agent) will assess the safety, tolerability, pharmacokinetic, and pharmacodynamics profile of PEN-866 (single agent) at the recommended Phase 2 dose determined at the conclusion of Phase 1a in patients with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1a PEN-866 Sodium (Single Agent) | Experimental | Drug: PEN-866 SodiumDose escalation of PEN-866 Sodium administered intravenously |
| Phase 1b PEN-866 Sodium + Flurouracil + Folinic Acid | Experimental | Drug: PEN-866 Sodium, Drug: fluorouracil, Drug: Folinic acidDose escalation of intravenous administration of PEN-866 Sodium in combination with fluorouracil and folinic acid |
| Phase 2a PEN-866 Sodium (Single Agent) | Experimental | Drug: PEN-866 SodiumIntravenously administered PEN-866 Sodium at the Recommended Phase 2 Dose |
| Phase 1b PEN-866 Sodium + Niraparib | Experimental | Drug: PEN-866 Sodium, Drug: NiraparibDose escalation of intravenous administration of PEN-866 Sodium in combination with niraparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- M/F at least 18 years old
- Performance status 0 or 1
- Adequate bone marrow, liver, and kidney function within 28 days prior to first dose
- Serum potassium, calcium, magnesium, phosphorus within normal limits
- Adequate birth control
Key exclusion criteria (24 listed)
- Treatment with anticancer therapy or investigational drug or device within 2 wk (6 wk for nitrosureas or mitomycin C) before C1D1, and any drug-related toxicities must have recovered to grade 1 or less with the exception of alopecia and peripheral neuropathy.
- Phase 2a only: Prior treatment with topoisomerase I inhibitor(s).
- Cardiac disease such as unstable angina within 6 months of screening, myocardial infarction within 6 months of screening, NY Heart Association Class III - IV heart failure, QTc greater than 470 msec, congenital long Qt syndrome, symptomatic orthostatic hypotension within 6 months of screening, uncontrolled hypertension, or clinically important abnormalities in heart rhythm, conduction, morphology of resting ECG.
- -For Phase 1b patients receiving the Niraparib combination only: hypertension as defined as diastolic > 90 mmHg or systolic > 140 mmHg
- Stroke or transient ischemic attack within 6 months of screening
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 |
|---|---|---|
| PEN-866 SodiumPEN-866 Sodium is a miniaturized conjugate that comprises an HSP90 targeting ligand linked to SN-38, the active metabolite of irinotecan. PEN-866 is available as a sterile lyophilized powder for solution for infusion. | Drug | Phase 1a PEN-866 Sodium (Single Agent), Phase 1b PEN-866 Sodium + Flurouracil + Folinic Acid, Phase 1b PEN-866 Sodium + Niraparib, Phase 2a PEN-866 Sodium (Single Agent) |
| fluorouracilAlso: 5-Fluorouracil, 5-FUFluorouracil 2400 mg/m2 IV | Drug | Phase 1b PEN-866 Sodium + Flurouracil + Folinic Acid |
| Folinic acidAlso: LeucovorinFolinic acid 400 mg/m2 IV | Drug | Phase 1b PEN-866 Sodium + Flurouracil + Folinic Acid |
| NiraparibAlso: ZejulaNiraparib | Drug | Phase 1b PEN-866 Sodium + Niraparib |
Primary outcome
Phase 1a and 1b : Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Patients will be followed for 28 days to determine the incidence of DLTs.
The Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) will be determined by assessing the incidence of DLTs and treatment related adverse events of PEN-866 as a single agent (Phase 1a) or in combination therapy (Phase 1b).
All Phases: Incidence of treatment related adverse events (Safety and tolerability)
Time frame: From date of first treatment/trial entry up to 28 days following the last treatment.
Safety and tolerability will be determined by assessing the incidence of treatment related adverse events.
Phase 2a: Efficacy of PEN-866 in patients with SCLC using best overall response rate
Time frame: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Efficacy of PEN-866 in patients with SCLC will be assessed using best overall tumor response rate defined as complete response (CR) or partial response (PR) according to RECIST 1.1.
Phase 2a: Efficacy of PEN-866 in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma using best overall response rate
Time frame: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Efficacy of PEN-866 in patients with gastric or GEJ adenocarcinoma will be assessed using best overall tumor response rate defined as CR or PR according to RECIST 1.1.
Phase 2a: Efficacy of PEN-866 in patients with pancreatic adenocarcinoma using Disease Control Rate (DCR)
Time frame: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Efficacy of PEN-866 in patients with pancreatic adenocarcinoma will be assessed using DCR defined as a best response of CR, PR, or stable disease (SD) according to RECIST 1.1.
Phase 2a: Efficacy of PEN-866 in patients with endometrial adenocarcinoma using best overall response rate
Time frame: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Efficacy of PEN-866 in patients with endometrial adenocarcinoma will be assessed using best over all tumor response rate defined as CR or PR according to RECIST 1.1.
Phase 2a: Efficacy of PEN-866 in patients with squamous cell carcinoma of the genitalia (anus, cervix, vulva, or penis) using best overall response rate
Time frame: From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Efficacy of PEN-866 in patients with squamous cell carcinoma of the genitalia will be assessed using best over all tumor response rate defined as CR or PR according to RECIST 1.1.
11 secondary outcomes
Maximum concentration (Cmax) of PEN-866 and its components (HSP90 ligand and SN-38)
Time frame: 1 Month (Phase 1a); 14 days (Phase 1b); assessed up to (estimated) 18 months for Phase 2a
Area under the curve (AUC) of PEN-866 and its components (HSP90 ligand and SN-38)
Time frame: 1 Month (Phase 1a); 14 days (Phase 1b); assessed up to (estimated) 18 months for Phase 2a
Half-life (t1/2) of PEN-866 and its components (HSP90 ligand and SN-38)
Time frame: 1 Month (Phase 1a); 14 days (Phase 1b); assessed up to (estimated) 18 months for Phase 2a
Phase 1b: Characterize the plasma pharmacokinetics (PK) of the combination therapies and their components
Time frame: 14 days
Phase 1a: Tumor response using RECIST 1.1 criteria
Time frame: Baseline and every 6 weeks until date of first documented progression or death (estimated 6 months)
Phase 1b: Disease Control Rate
Time frame: From date of first treatment through the date of date of first documented progression, assessed up to (estimated) 18 months
Phase 2a: Disease Control Rate in patients with SCLC, gastric or gastroesophageal junction adenocarcinoma, endometrial adenocarcinoma, and squamous cell carcinoma of the genitalia (anus, cervix, vulva, and penis)
Time frame: From date of first treatment through the date of date of first documented progression, assessed up to (estimated) 18 months
Phase 2a: Evaluate the best overall response rate in patients with pancreatic adenocarcinoma
Time frame: From date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
Phase 1b and 2a: Duration of Response
Time frame: From date of first treatment until the date of date of death from any cause, assessed up to (estimated) 18 months
Phase 2a: Radiographic progression free survival
Time frame: From date of first treatment until the date of first documented progression or date of death from any cause, whichever is first, assessed up to (estimated) 18 months
Phase 2a: Overall survival
Time frame: From date of first treatment until the date of date of death from any cause, assessed up to (estimated) 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Anish Thomas, MD study chair
National Cancer Institute (NCI)
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PEN-866 Sodium, fluorouracil and Folinic acid in people with Carcinoma and Endometrial Adenocarcinoma, run by Tarveda Therapeutics at 16 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 18 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tarveda Clinical Information Center ((617) 923-4100, clinical.information@tarvedatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a and 1b : Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Patients will be followed for 28 days to determine the incidence of DLTs.). The study lists 7 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 17 Feb 2022.